Self-acupressure for Cancer-related Symptom Cluster of Insomnia, Depression, and Anxiety in Cancer Patients: a Feasibility Randomized Controlled Trial
Phase: NA
Conditions: Insomnia, Anxiety, Depression
Sponsor: The Hong Kong Polytechnic University

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SELF-ACUPRESSURE FOR CANCER-RELATED SYMPTOM CLUSTER OF 
INSOMNIA, DEPRESSION, AND ANXIETY IN CANCER PATIENTS: A 
FEASIBILITY RANDOMIZED CONTROLLED TRIAL  
 
 
 
 
 
 
 
PhD Student: HOANG Thi Xuan Huong (16901761r) 
 
 
 
 
Chef supervisor: Prof. MOLASSIOTIS Alex 
 
 
 
 
Co-Supervisor: Dr. CHAN Choi Wan 
 
 
 
 
 
 
 
 
 
 
The Hong Kong Polytechnic University 
November 2018 

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Contents 
1. 
Background .......................................................................................................... 6 
2. 
Aim ........................................................................................................................ 8 
3. 
Objective of the study .......................................................................................... 8 
4. 
Methodologies of the study.................................................................................. 8 
4.1. The theoretical framework of the intervention .................................................. 8 
4.2. Aim and objectives of the study: ........................................................................ 12 
4.2.1. Aim of the study ........................................................................................... 12 
4.2.2. Objectives of the study ................................................................................. 12 
4.3. The application of the MRC framework for the development of the 
intervention. .............................................................................................................. 12 
4.4. The development of the self-acupressure protocols for managing insomnia, 
depression, and anxiety ............................................................................................ 16 
4.4.1. The development of the true self-acupressure protocol. .............................. 16 
4.4.1.1. Justification of the selected acupoints ...................................................... 16 
4.4.1.2. Justification for the dose of the self-acupressure treatment ...................... 18 
4.4.2. Development of Protocol for the sham self-acupressure ............................. 24 
4.4.2.1. Justification for choosing sham acupressure approach ............................. 24 
4.4.2.2. Sham self-acupressure protocol ................................................................ 24 
4.4.3. Validation of the true self-acupressure and sham self-acupressure protocol
 .............................................................................................................................. 28 

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4.5. Methods of the feasibility study .......................................................................... 35 
4.5.1. The study design ............................................................................................... 35 
4.5.2. Study participants ......................................................................................... 36 
4.5.3. Trial arms ..................................................................................................... 37 
4.5.4. Outcomes measurement ............................................................................... 42 
4.5.5. Sample size .................................................................................................. 46 
4.5.6. Settings ......................................................................................................... 46 
4.5.7. Randomization, allocation concealment, and blinding ................................ 47 
4.5.7.1. Randomization and allocation concealment. ............................................ 47 
4.5.7.2. Blinding ..................................................................................................... 48 
4.5.8. Study procedures .......................................................................................... 49 
4.5.9. Fidelity of the study ..................................................................................... 54 
4.5.10. Ethical consideration .................................................................................. 57 
4.5.11. Data Analysis ............................................................................................. 59 
4.6. Potential implication of the study ...................................................................... 60 
Potential implication for nursing research ............................................................. 60 
The potential implication for nursing practice ....................................................... 60 
4.7. Proposed timeline for the study .......................................................................... 62 
4.8. Estimated Budget for study ................................................................................ 63 
REFERENCES ........................................................................................................... 64 

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Appendix 1. Assessment and Evaluation form (English and Vietnamese version)
 .............................................................................................................................. 71 
Part 1. Demographic data .......................................................................................... 71 
Part 2. Health history ................................................................................................. 71 
Part 3. Insomnia Severity Index ................................................................................ 72 
Part 4. Assessment depression and Anxiety ............................................................. 73 
Part 5. Assessment Quality of Life ............................................................................ 75 
Part 6. Assessment the severity of the cluster of insomnia, depression, and 
anxiety ........................................................................................................................ 76 
Part 7. Sleep diary ...................................................................................................... 77 
Part 8. Self-Acupressure Record Form .................................................................... 79 
Appendix 2.  The intervention rating profile-15 ...................................................... 91 
Appendix 3. Protocol for the self-acupressure training section for participants . 93 
Appendix 4. Interventionist Skill Check of Acupressure and Sham Acupressure
 .............................................................................................................................. 94 
Appendix 5. Acupressure Skill Check Forms for participants* ............................ 98 
Appendix 6. Acupresssure Protocol Validation Form .......................................... 102 
 
 
 
 
 

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List of tables 
Table 1. Standard protocol for self-acupressure for insomnia, depression, and anxiety
 ...................................................................................................................................... 21 
Table 2. Sham acupressure protocol ............................................................................. 25 
Table 3. Characteristics of experts in the panel for validating treatment protocols ..... 28 
Table 4. Components of proposed acupressure protocols do not meet the agreement 
level in the first round of validation study .................................................................... 31 
Table 5. Result of the true acupressure protocol validation ......................................... 32 
Table 6. Results of the sham acupressure protocol validation ..................................... 33 
Table 7. The revised acupressure protocols ................................................................. 34 
Table 8. Detail of provided components in each study arm. ........................................ 41 
Table 9. Time points for data collection ....................................................................... 45 
List of figures 
Figure 1. The Theory of Unpleasant Symptoms (Lenz & Pugh, 2003, p. 170) ............. 9 
Figure 2. Theoretical framework of the intervention (Adapted from TOUS) .............. 11 
Figure 3. The MRC's framework for Developing and Evaluating Complex 
Intervention ................................................................................................................... 13 
Figure 4. Process of study design following the MRC framework for Developing and 
Evaluating Complex Interventions ............................................................................... 15 
Figure 5. The flowchart of the study ............................................................................ 52 
 
 

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1. 
Background 
Cancer is the term of more than 200 different diseases caused by an uncontrolled 
division of abnormal cells in a part of the body and spread to other organs and it is a 
leading cause of death worldwide, with approximately nearly one in six deaths being 
due to cancer globally (World Health Organization, 2017). Cancer is rapidly becoming 
a global pandemic and it is estimated that by 2030 there will be 21.7 million cases and 
13 million deaths worldwide (American Cancer Society, 2017).  
According to World Health Organization, the main purpose of cancer treatment is to 
cure or prolong the patient’s life as well as ensure the best possible quality of life for 
cancer survivors. Major treatments for cancer include surgery, radiotherapy, and 
chemotherapy improve patient’s survival but also can exert a significant psychosocial 
and physical impact on patients by producing a variety of unpleasant symptoms. Among 
different kind of cancer treatments, chemotherapy is considered partially to cause 
insomnia (Dahiya, Ahluwalia, & Walia, 2013). As a result, insomnia is a common 
symptom among patient undergoing chemotherapy treatment. However, insomnia often 
goes unrecognized and receives litter attention compared to other symptoms (e.g., pain, 
fatigue, depression) by clinicians and researchers (Dahiya et al., 2013; J Savard & 
Morin, 2001). Literature suggests that insomnia reduce patient’s quality of life 
significantly (Clevenger et al., 2013; Davidson et al., 2002; Romito et al., 2014; Vargas 
et al., 2010). Nevertheless, recent studies also indicated insomnia co-occurs with others 
symptoms to form a sleep-related symptom cluster. A symptom cluster has been firstly 
defined as three or more symptoms occurring together, related to each other and may 
not have the same etiology (Dodd, Miaskowski, & Paul, 2001). Recently, other research 
has expanded the concept of symptom clusters and defined it as “two or more symptoms 
that are clinically meaningful together, related to each other at a given time and share a 
significant variance in their cluster” (Molassiotis, Wengström, & Kearney, 2010). 
Applying the concept of identification symptom cluster by the correlation between 
symptom, different sleep-related symptom clusters among cancer patient have been 
identified across studies such as: fatigue, depression and insomnia (Ho, Rohan, Parent, 

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Tager, & McKinley, 2015; Roscoe et al., 2007); pain, fatigue and insomnia (Chen & 
Tseng, 2006; Cleeland et al., 2000; Ivanova et al., 2005; Romito et al., 2014) or pain, 
depression, and insomnia (J. Savard et al., 2005). However, due to the limitation of 
previous studies, the correlation between insomnia and other symptoms was not fully 
explored. Therefore, to identify current evidence of sleep-related symptom cluster, we 
have conducted a cross-sectional survey among 213 cancer patients undergoing 
chemotherapy in Vietnam. The results indicated that among participants, a symptom 
cluster of insomnia, depression, and anxiety was evident.  
The result of our survey indicates the needs to develop an intervention aimed at 
managing sleep-related symptom cluster. However, interventions to manage sleep-
related symptom cluster are still infancy in the literature. To date, only eight studies 
have tested an intervention designed to manage a sleep-related symptom cluster. In 
those randomized control trials, non-pharmacological treatments (psycho-education, 
cognitive behavioral strategies, and acupressure) were used to managing the pain, 
fatigue and sleep disturbance symptom cluster with some initial evidence of success 
(Kwekkeboom, 2016).  Therefore, further development of sleep-related symptom 
cluster intervention is needed. Nevertheless, while most current treatment not only 
required the physical presence of healthcare provider to deliver and manage but also 
consume more time, money and effort for patient to administer, there is sufficient 
evidence to support the development of a self-management intervention that can 
potentially improve insomnia.  
Based on the literature review, acupressure can potentially reduce insomnia as well as 
other symptoms in cancer patients. This is a safe and non-invasive treatment with 
minimal unpleasant for patients. However, the use of acupressure in specific self-
acupressure in managing symptom cluster of insomnia, depression, and anxiety is 
unknown but worthy for further research. Therefore, there is a need for conducting an 
intervention study to evaluate the effectiveness of using self-acupressure to manage this 
cluster in cancer patients. 
 

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2. 
Aim 
To assess the acceptability and make estimations about the effectiveness of the 
intervention using self-acupressure to manage the symptom cluster of insomnia, 
depression, and anxiety in cancer patients undergoing chemotherapy. 
3. 
Objective of the study  
- 
To evaluate recruitment capability. 
- 
To evaluate the acceptability of the intervention and study procedures. 
- 
To identify potential adverse events associated with self-acupressure. 
- 
To preliminary evaluate the effects of self-acupressure on the severity of 
insomnia, depression, anxiety, and severity of the symptom cluster of these 
symptoms. 
- 
To preliminary evaluate the effects of self-acupressure on participants’ sleep 
parameter (Total Sleep time (minute), total time in bed (minute), the number of 
night awaken after sleep onset and sleep efficiency)    
- 
To preliminary evaluate the effects of self-acupressure on participants’ quality 
of life. 
- 
To determine the sample size for the future full-scaled randomized controlled 
trial. 
- 
To refine the study protocol for a future full-scaled randomized controlled trial. 
4. 
Methodologies of the study 
4.1. The theoretical framework of the intervention 
In this study, the Theory of Unpleasant Symptoms (TOUS) developed by Lenz et al. 
(1997) is used to explain how acupressure can help in reducing the severity of symptom 
cluster and model the outcome of the trial. There are three components in the TOUS 
which are: experienced symptoms, influencing factors, and performance. The model 

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proposed that symptoms can occur alone or in association with others. Every symptoms 
four dimensions: timing (frequency, duration, and pattern of symptom’s occurrence) 
distress (degree the symptoms bother) intensity (severity of the symptoms) and quality 
(nature of the symptoms).  Influencing factors are determinants of symptoms. They are 
classified as: Psychology, physiologic and situational variables and they relate to each 
other and influence symptoms. The third component of TOUS is Performance. 
Performance is the results of the symptoms experience which includes functional and 
cognitive activities. The model assumes that more numerous or more severe symptom, 
the worse the performances manifested. These components of the model interact with 
each other. Influencing factors determine symptoms, symptoms influence patient’s 
performance and the performance can also conversely impact on symptoms and the 
influencing factors. The figure below depicts the TOUS  
 
Figure 1. The Theory of Unpleasant Symptoms (Lenz & Pugh, 2003, p. 170) 
According to the Traditional Chinese Medicine theory, the symptoms (insomnia, 
depression, and anxiety) are caused by pathogenic changes in Qi, the imbalance of Yin 
and Yang (Liu, 1998) and the insufficiency of blood circulation to the organs (Li, 2007, 
p. 1023). As such, in this study, the “pathogenic changes in Qi,” “the imbalance of  Yin 
and Yang,” and “the insufficient of blood circulation” are categorized as “influence 
factors” in the model. This trial tackles the “influence factors” by using acupressure. 

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Stimulating acupoints improves the symptom cluster by incresing the blood circulation 
resulting in enhancing Qi and balancing the Yin and Yang (Li, 2007, p. 1023). Improving 
this symptom cluster will cause the effect on patient’s “performance”. Therefore, the 
primary outcomes of the intervention are the “symptoms” the secondary outcome is 
“performance” According to the TOUS, symptoms are measured in four dimensions. 
However, founders of the model suggested measuring one, two, or three dimensions of 
symptoms is “valid and informative for assessing the effectiveness of an intervention” 
(Lenz & Pugh, 2003, p. 174). Therefore, in this study, we measure the intensity which 
refers to the severity of the symptoms. Several specific and standardized measurements 
will measure the severity of individual symptoms in the cluster. Since the symptoms in 
the cluster co-occurred together and correlated to each other, the symptoms severity at 
a cluster level will also be measured. The “performance” in the TOUS model is defined 
as patient’s quality of life in this study. The theoretical framework of the trial is depicted 
in figure 3. 

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Figure 2. Theoretical framework of the intervention (Adapted from TOUS) 
 
 
Depression 
Anxiety 
Pathogenic 
changes in Qi 
Imbalance of 
Yin and Yang 
 Quality of life 
Insomnia 
Severity 
             Influences 
             Interacts with 
Self-acupressure 
Sufficiency of blood 
circulation to the organs 

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4.2. Aim and objectives of the study:  
4.2.1. Aim of the study 
 To assess the acceptability and make estimations about the effectiveness of the 
intervention using self-acupressure to manage the symptom cluster of insomnia, 
depression, and anxiety in cancer patients undergoing chemotherapy. 
4.2.2. Objectives of the study 
- 
To evaluate recruitment capability. 
- 
To evaluate the acceptability of the intervention and study procedures. 
- 
To identify potential adverse events associated with self-acupressure. 
- 
To preliminary evaluate the effects of self-acupressure on the severity of 
insomnia, depression, anxiety, and severity of the symptom cluster of these 
symptoms. 
- 
To preliminary evaluate the effects of self-acupressure on participants’ sleep 
parameter (Total Sleep time (minute), total time in bed (minute), the number of 
night awaken after sleep onset and sleep efficiency)    
- 
To preliminary evaluate the effects of self-acupressure on participants’ quality 
of life. 
- 
To determine the sample size for the future full-scaled randomized controlled 
trial. 
- 
To refine the study protocol for a future full-scaled randomized controlled trial. 
4.3. The application of the MRC framework for the development of the 
intervention. 
A complex intervention has been defined as an intervention which contains several 
interacting components, and this kind of intervention has been used widely in healthcare 
research (Craig et al., 2008). The framework provides researcher an appropriate 
framework for developing and evaluating an intervention. The key elements of the 

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development and evaluation process include development phase, feasibility, and 
piloting phase, evaluation phase, and implementation phase. Figure 3 depicts the 
components of MRC framework.  
 
Figure 3. The MRC's framework for Developing and Evaluating Complex Intervention 
In the first phase of the MRC framework is the development of the intervention. In this 
phase evident and the related theory of the intervention must be identified, and the 
process and outcomes should also be modeled. The second phase is the feasibility and 
piloting phase, the procedures of the intervention are tested to make an important 
estimation of the future full-scale randomized control trial (e.g., recruitment rate, 
sample size). In the third phase - evaluation phase, the effectiveness of the intervention 
is assessed by conducting a full-scale randomized control trial. In the implementation 
phase, the intervention is disseminated and also the long-term follow up, surveillance 
and monitoring of its effectiveness should be conducted. The four phases are in a cycle 
in which study can move backward and forward between the phases. If a problem is 
identified that make the study impossible to move to next stage, the study must be 
revised and can move back to the previous phase.  
In this doctoral research study, three research works are conducted to study the effects 
of self-acupressure in managing the cluster of insomnia, depression, and anxiety among 
cancer patients undergoing chemotherapy. The three research works are the cross-

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sectional survey, literatural reviews, and the feasibility study. This study will cover the 
first two phases in the MRC framework. 
In the first phase of MRC framework, the cross-sectional survey was conducted to 
ascertain the magnitude of insomnia among Vietnamese cancer patients. Nevertheless, 
it also hepls to determine factors that influence the result of the intervention that need 
to be controlled (e.g. patient’s characteristics, treatment-related factors), to determine 
the correlation between insomnia and other symptoms, and to make the decision on 
choosing the outcome measurement for the future intervention study.  
In the second phase of the MRC framework, a feasibility study with three groups 
intervention will be implemented to assess the acceptability of the intervention and 
make estimations about the effectiveness of using self-administered acupressure for 
managing cancer-related symptom cluster of insomnia, depression, and anxiety. Before 
testing the intervention protocol, evidence-based acupressure treatment protocol and 
sham acupressure protocol were being developed based on available systematic 
reviews, TCM theories, and TCM textbook, and were evaluated by a group of TCM 
experts for the appropriateness of the protocol for use in cancer patients. Afterward, a 
feasibility study designed as a  randomized placebo-control trial study was designed to 
evaluate the feasibility and acceptability of the intervention and study’s procedures. The 
process of current study design following the MRC framework for Developing and 
Evaluating Complex Interventions is presented in Figure 4.  The development of 
evidence-based acupressure treatment protocol and sham acupressure protocol  is 
detailed in the next sections. 

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Feasibility/piloting 
Test procedures 
Estimating recruitment/retention 
Determining sample size 
Implementation 
Dissemination 
Surveillance and monitoring 
Long term follow-up 
Development 
Identifying the evidence base 
Identifying develop the theory 
Modeling process and outcomes 
Phase 1 
- Identify the magnitude of insomnia, 
factors that influence the result of the 
intervention, correlation between insomnia 
and 
other 
symptoms, 
outcomes 
measurement. 
 
Phase 2 
Three-arm randomized controlled feasibility 
study will be conducted evaluate: 
- 
The 
recruitment 
capacity 
and 
acceptability of the intervention 
- 
Potential adverse events associated 
with self-acupressure 
- 
The 
effects 
of 
intervention 
(preliminary) 
- 
The sample size for the future full-
scale RCT 
Evaluation 
Assessing effectiveness 
Understanding change process 
Assessing cost-effectiveness 
Figure 4. Process of study design following the MRC framework for Developing and Evaluating Complex Interventions 

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4.4. The development of the self-acupressure protocols for managing insomnia, 
depression, and anxiety  
Self-acupressure treatment protocol for managing the symptom cluster of insomnia, 
depression, and anxiety in cancer patients was developed. To distinguish the specific 
treatment (true) effects of acupressure treatment from the nonspecific treatment 
(placebo) effects, a true self-acupressure protocol and a sham self-acupressure protocol 
were being developed accordingly. The true acupressure protocol was developed based 
on the theory of Traditional Chinese Medicine (TCM) (Li, 2007; Young, 2001), 
available systematic reviews are used for selecting acupoints and choosing treatment 
dose (Pilkington, 2010; Tan, Suen, Wang, & Molassiotis, 2015; Waits, Tang, Cheng, 
Tai, & Chien, 2016; Yang et al., 2013; Yeung et al., 2012b), and WHO standard 
acupuncture point location guidelines were used to locate the acupoint and technique 
for self-acupressure (World Health Organization, 2009). Meanwhile, the sham 
acupressure was developed based on available systematic review and recommendation 
from TCM experts. This section describes the development of self-acupressure 
protocols based on systematic reviews and the validation of the acupressure protocols. 
4.4.1. The development of the true self-acupressure protocol. 
4.4.1.1. Justification of the selected acupoints 
From Traditional Chinese Medicine (TCM) theory, the frequently involved organs 
causing insomnia, depression, and anxiety are heart, liver, stomach, and spleen (Young, 
2001). Based on this point, Acupoints are selected based on their effect on the organs 
and their effect on the symptoms from the literature reviews. 
In a systematic review from 43 studies on the efficacy of acupressure for insomnia, 
Yeung et al. (2012a) indicated the commonly used acupoints were: Baihui (GV20), 
Shenmen (HT7), Taiyang (EX-HN5), Fengchi (GB20), Yintang (EX-HN3) and 
Sanyinnjiao (SP6). Regarding depression and anxiety, Baihui (GV20), Yintang (EX-
HN3). Taichong (LR3), Hegu (LI4) and Shenmen (HT7) were listed as commonly used 
acupoints from a review of 13 studies (Pilkington, 2010). From this evidence, Baihui 

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(GV20), Yintang (EX-HN3), Shenmen (HT7), Fengchi (GB20) and Hegu (LI4), 
Taichong (LR3) are included in the acupressure protocol for this study.  
Baihui (GV20) linked with all Yang channels, this acupoints response for sufficiency 
of blood circulation in the Heart and Spleen resulting in enhancing the “the source of 
generation and transformation of Qi and Blood” to improve insomnia, depression, and 
anxiety. The combination of GV20 and HT7 supplies and boosts the Heart and Spleen 
(Li, 2007). 
Shenmen (HT7) has been demonstrated to be effective in improving sleep across 
studies in both cancer and non-cancer population (Cerrone et al., 2008; Sok, Erlen, & 
Kim, 2003; Sun, Sung, Huang, Cheng, & Lin, 2010; Yeung et al., 2012a). Also, HT 7 
proved to stimulate the release of Melatonin from the pineal gland (Spence et al., 2004). 
HT 7 is selected to supplement, clear and settle the Heart also calm the Spirit to treat 
insomnia, depression, and anxiety by “depletion of Blood in the Heart and Spleen, Qi 
deficiency of the heart and Gall-bladder, effulgent Yin deficiency fire and disharmony 
of the stomach (Li, 2007). 
Fengchi (GB20) has been demonstrated to be effective to clear the Brain and calm the 
sleep. It was commonly used to treat insomnia due to depletion of blood in the Heart 
and Spleen or lack of interaction between the Heart and the Kidneys or Qi deficiency in 
the body. This acupoint is related to depression and anxiety (Li, 2007). 
Yintang (EX-HN3) has been demonstrated to treat insomnia, depression, and anxiety 
by calming the mind (Marley, 2010). 
Hegu (LI4):  is effective in treating disorders of the spirit and mind and commonly uses 
in the treatment of disease pattern due to Qi deficiency (Li, 2007). 
Taichong (LR3): has demonstrated to treat the symptoms related to activities of Liver 
Qi such as depression, anger by enhancing and regulates the functions of the liver and 
eliminates pathological symptoms and sign caused by dysfunction of the liver (Li, 2007) 

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4.4.1.2. Justification for the dose of the self-acupressure treatment  
The dose of the treatment refers to the combination of frequency and duration of each 
treatment section and duration of the treatment period. This section will report the 
justification for choosing the duration of the treatment, the frequency, and duration of 
each treatment section. 
Duration of the whole treatment and frequency of each treatment section 
An optimal acupressure treatment dose is a gap in the literature since a wide range of 
duration treatment was reported, and the guidelines for such dose of each symptom or 
disease have not been established (Deng et al., 2015). Therefore, we reviewed previous 
systematic reviews to find an optimal acupressure treatment duration and frequency of 
insomnia, depression, and anxiety. 
In the systematic review on managing cancer-related insomnia, Choi, Kim, Lim, and 
Lee (2016) reported the duration of treatment was one week to ten weeks with the 
frequency was once a day. Among six studies included in this review, the duration of 
four or five weeks resulted in a significant improvement of sleep (Bokmand & Flyger, 
2013; Williams, Kay, Rowe, & McCrae, 2013) while the shorter duration (one week) 
and longer duration (ten weeks) did not (Mao et al., 2015; Song, Zhao, Peng, & Hu, 
2015). In general population, a systematic review of 32 RCTs indicated most treatment 
protocols involved a duration of three to four weeks with the frequency was once a day 
(Waits et al., 2016). Yeung et al. (2012a) reviewed 40 RCTs and indicated the effects 
of acupressure on improving insomnia were observed after four weeks of treatment. 
Therefore, an acupressure treatment duration of four weeks with the frequency of once 
a day seems to be optimal for improving insomnia (equal to 28 sections).   
For the duration of clinical anxiety, a review from twelve studies conducted by 
Pilkington, Kirkwood, Rampes, Cummings, and Richardson (2007) reported that 
treatment duration was six days to six weeks with the frequency was once a day. The 
finding of this review indicated the treatment group showed a significant improvement 
than the control with six days to ten days treatment duration (equal to six to ten treatment 
sections) but not with longer duration (six weeks, 30 treatment sections).  

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Regarding the duration of depression, a various duration of treatment from two weeks 
to sixteen weeks with the frequency ranged from once a week to twice a week (total 
sessions ranged from ten to 30) was reported in systematic reviews (Pilkington, 2010; 
Wang et al., 2008). The result from this two reviews indicated the duration of six to 
eight weeks with a frequency of once to twice a week (equal to six to 16 treatment 
sections) brought significant improvement in the intervention group compared with 
control groups.  
To summarize, evident from available systematic reviews suggests that a frequency of 
once a day in four weeks (equal to 28 treatment sections) is optimal for improving 
insomnia, once a day in six to ten days (equal to six to ten treatment sections) and once 
to twice a week in six to eight weeks (equal to six to 16 treatment sections) are the 
appropriated duration treatment for anxiety and depression respectively. Based on the 
findings a duration of four weeks with a frequency of once a day which equal to 28 
treatment sections is applied to the acupressure protocol of this study since such dose 
of treatment covers the optimal doses for insomnia, depression, and anxiety. 
Duration of each treatment section 
The duration of each treatment section is calculated on the number of acupoints and the 
stimulation time for each acupoint. Systematic reviews indicated the time to stimulate 
a acupoint rank from one to three minute which made the length of each treatment 
section ranged from 15 to 45 minutes (Choi et al., 2016; Pilkington, 2010; Pilkington et 
al., 2007; Waits et al., 2016; Wang et al., 2008; Yeung et al., 2012a). Others recent 
studies also showed that practicing acupressure three minutes per acupoint significantly 
reduced the burden of the symptoms (Abedian, Eskandari, Abdi, & Ebrahimzadeh, 
2015; Lu, Lin, Chen, Tsang, & Su, 2013; Tsay & Chen, 2003; Zheng, Chen, Chen, 
Zhang, & Wu, 2014). Based on these finding, participants will perform self-acupressure 
with three-minute stimulation per acupoint. There are six acupoints with four of the 
acupoint located on both sides of the body giving a total of ten acupoints to stimulate. 
Among these acupoints that located on both sides of the body, Fengchi and Taichong 
can be pressed bilaterally at a time. Therefore, the duration of treatment time is 24 
minutes.  

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Intensity and technique for self-acupressure 
According to the TCM theory, acupressure only shows its effects on symptoms when 
patients experience deqi sensation (Yang et al., 2013). The deqi sensation is described 
as the feeling of sore, numb, heavy, distended and warm at the acupoints and is felt by 
patients (Tsay & Chen, 2003; Yeung et al., 2017). Therefore, the technique for 
acupressure using in this study will be using the thumb pad to massage the surrounding 
area of the specific acupoint firmly and the participant must feel the deqi sensation 
during performing self-acupressure. However, the pressure techniques for Baihua and 
Fengchi are different from other acupoints due to their specific locations (on the scalp). 
For Baihua, participants use four finger pads to tap gently the area of this acupoint on 
the scalp. For Fengchi, participants using two thumbs, press in the acupoint bilaterally 
while the other four fingers should hold the back of the head naturally. The self-
acupressure protocol is depicted in Table 1.  
Time for practicing acupressure 
Participants will perform self-acupressure one hour before going to bed since 
stimulation of Shenmen has been proved to release Melatonin (Spence et al., 2004). 

21 
 
Table 1. Standard protocol for self-acupressure for insomnia, depression, and anxiety 
Sequence/acupoint Location (*) 
Pressing technique 
Frequency, duration 
1. Baihui (GV20) 
On the head, 5 B-cun superior 
to the anterior hairline on the 
anterior median line (5 B-cun 
is equal to the distance from 
the center of the umbilicus to 
the superior border of the 
pubic symphysis) 
 
 
using four finger pads, 
gently tap the area of this 
acupoint on the scalp  
3 minutes 
Once a day for four 
weeks 
2. Yintang (EN-
HN3) 
The midpoint between the 
eyebrows 
 
using thumb pad, firmly 
massage the surrounding 
area of this acupoint 
3 minutes 
Once a day for four weeks 

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3. Fengchi (GB20) 
In the anterior region of the 
neck, inferior to the occipital 
bone, in the depression 
between the origins of 
sternocleidomastoid and the 
trapezius muscle 
 
using two thumbs, press in 
the acupoint bilaterally 
while the other four fingers 
should hold the back of the 
head naturally 
3 minutes for each side 
(total 3 minutes, both side 
at the same time) 
Once a day for four weeks 
Sequence/acupoint Location (*) 
Pressing technique 
Frequency, duration 
4. Hegu (LI 4) 
On the dorsum of the hand, 
radial to the midpoint of the 
second metacarpal bone. 
Using thumb pad, firmly 
massage the surrounding 
area of this acupoints and 
press on the acupoints with 
rotation movements 
3 minutes for each side 
(total 6 minutes) 
Once a day for four weeks 

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5. Shenmen (HT7) 
On the anteromedial aspect of 
the wrist, radial to the flexor 
carpi ulnaris tendon, on the 
palmar wrist crease. 
 
Using thumb pad, firmly 
massage the surrounding 
area of this acupoint on the 
ulnar side of the wrist with 
rotation movements. 
3 minutes for each side 
(total 6 minutes) 
Once a day for four weeks 
6. Taichong (LR3) 
On the dorsum of the foot in 
the depression distal to the 
junction of the first and second 
metatarsal bones. 
 
Using thumb pad, firmly 
massage the surrounding 
area of this acupoints and 
press on the acupoints 
with rotation movements 
3 minutes for each side 
(total 3 minutes, both side 
at the same time) 
Once a day for four weeks 
* directly quote from World Health Organization (2009) 

24 
 
 4.4.2. Development of Protocol for the sham self-acupressure  
4.4.2.1. Justification for choosing sham acupressure approach 
In a recent systematic review on the application of sham acupressure in 66 randomized 
controlled trials, Tan et al. (2015)  listed out two approaches of using sham acupressure: 
using irrelevant acupoints/non-acupoints and using the same acupoints as true treatment 
with light touching. The approach of using the same acupoints as true treatment with 
light touching/no stimulation is believed not to create any therapeutic effect (Tan et al., 
2015), however, Vietnamese people are familiar with acupressure technique so the light 
stimulation may not be adequate to maintain blinding participants. Using irrelevant 
acupoints refers to the use of acupoints to relief different symptom (Zhang, Bian, & Lin, 
2010). This approach is also not appropriated as the “holism concept” of acupuncture 
theory indicated that every stimulation on any acupoints could create responses of the 
body and generate specific or non-specific effects (as cited in Tan et al., 2015). As such, 
it should not be included in the research design to investigate the specific effect of 
acupressure. Therefore, we decide to choose the using of non-acupoints approach for 
the protocol of sham-acupressure since pressing non-acupoints cannot produce any 
therapeutic effects and maintain blinding participants.  
4.4.2.2. Sham self-acupressure protocol 
Non-acupoints are located 2 to 5 cm away from the true acupoints. Location of sham 
acupoints and technique of sham acupressure are described in table 2. The treatment 
dose in the sham acupressure protocol will be the same as in the true acupressure 
protocol.  
 
 
 
 
 
 

25 
 
Table 2. Sham acupressure protocol  
Sequence/acupoint 
Location  
Pressing technique 
Frequency, duration 
SA 1 
3 cm from GV20 
 
using four finger pads, 
gently tap the area of this 
acupoint on the scalp  
3 minutes 
Once a day for four 
weeks 
SA 2 
3 cm away from 
Ying Tang 
 
using thumb pad, firmly 
massage the surrounding 
area of this acupoint with 
rotation movements at a 
rhythm of 1 second per 
cycle. 
3 minutes 
Once a day for four 
weeks 

26 
 
SA 3 
The mastoid bone 
 
using two thumbs, press in 
the acupoint bilaterally 
while the other four 
fingers should hold the 
back of the head naturally 
3 minutes 
Once a day for four 
weeks 
SA 4 
The head of ulnar 
styloid 
 
Using thumb pad, firmly 
massage the surrounding 
area of this acupoints and 
press on the acupoints 
with rotation movements  
3 minutes for each side 
(total 6 minutes) 
Once a day for four 
weeks 
SA 5 
The base of 
metacarpal bone of 
the index finger 
 
Using thumb pad, firmly 
massage the surrounding 
area of this acupoints and 
press on the acupoints 
with rotation movements 
3 minutes for each side 
(total 6 minutes) 
Once a day for four 
weeks 

27 
 
SA 6 
3 cm away from Tai 
Chong 
 
Using thumb pad, firmly 
massage the surrounding 
area of this acupoints and 
press on the acupoints 
with rotation movements 
3 minutes for each side 
(total 3 minutes, both 
side at the same time) 
Once a day for four 
weeks 

28 
 
4.4.3. Validation of the true self-acupressure and sham self-acupressure protocol 
A panel of TCM experts was invited to validate the suitability of self-acupressure 
treatment and sham self-acupressure protocol before implementation of the feasibility 
study. To provide a sufficient level of control for chance agreement, a panel of at six 
experts was recommended by Lynn (1986). Six TCM experts who specialized in TCM 
from Hong Kong and Vietnam were invited to validate treatment protocol. The six 
experts work in a university. All had at least ten years of working experience related to 
TCM and acupuncture. Among six experts, two was appointed as associate professors, 
two held the positions of assistant professor, one held the position of senior lecturer, 
and one held the position of clinical associate. The Characteristics of the six experts are 
presented in the table below. 
Table 3. Characteristics of experts in the panel for validating treatment protocols 
Characteristics of the Experts (n=6) 
Number (%) 
TCM registration location 
Hong Kong 
4 (67%) 
Vietnam 
2 (33%) 
Highest academic qualifications 
 
Doctorate 
5 (83.3%) 
Master’s degree 
1 (16.7%) 
Academic and professional rank 
 
Associate Professor 
2 (33.3%) 
Assistance Professor 
2 (33.3%) 
Senior Lecturer 
1 (16.7%) 
Clinical Associate 
1 (16.7%) 
 
After identifying potential members of the panel, an invitation email was sent by the 
researcher to each member. The experts had one week to respond to the invitation 
(Rubio, Berg-Weger, Tebb, Lee, & Rauch, 2003). After receiving the invitation letter, 
all six experts agreed to participate in the study. Afterward, a cover letter briefly 
introduced the study purposes, the criteria for selecting experts, intervention protocol 
and scoring method (Rubio et al., 2003) was sent to experts. The acupressure protocols 
were made to assessment form. Each expert rated each item on the acupressure protocol 
by using a 4-point Likert scale, where four = very appropriate, 3 = appropriate, 2 = 
inappropriate, and 1 = very inappropriate. Comment or suggestion for each item will be 

29 
 
encouraged (Please appendix 9). Experts were required to return their feedback by email 
within one week of receiving the assessment form. For expert who did not reply, a 
gently reminder was sent two days after the deadline for returning the validation form. 
The validity index for each component (C-VI) was calculated based on the number of 
the expert rate the acupoints either “very appropriate” or “appropriate” divided by the 
total number of experts. The components were rated as valid when at least five out of 
six experts agree as “very appropriate” or “appropriate”. The C-VI should be at least 
0.83; an item has C-VI less than 0.83 were revised based on comments and suggestions 
of experts (Lynn, 1986). The validity index for the whole acupressure protocol (P-VI) 
was calculated based on the average C-VI (Lynn, 1986; Rubio et al., 2003). An C-VI of 
0.83 was considered as a satisfactory agreement level.   
Two round of validation was conducted in this doctoral research project. In the 
first round of validation study the majority of components in the true and sham 
acupressure protocols reached the consensus between experts. However, there were two 
components in the true acupressure protocol, and three in the sham acupressure protocol 
did not meet the agreement level (Table 4). In the proposed true acupressure protocol, 
Hegu was rated as inappropriate by two experts. One expert did not provide the reason 
for his decision but suggest to use Neiguan (PC6) instead because Neiguan (PC6) can 
support Shenmen to promote sleep better. Another expert indicated to trigger the effect 
of Hegu; participant should press until it is sore. Moreover, this is not pleasant, and the 
subject sure will not be pressing hard enough throughout the entire course of the 
treatment. The pressing technique of Baihua was also rated as inappropriate by two 
experts because they indicated the proposed pressing technique was wrong. In the 
proposed sham acupressure protocol, the location sham acupoint SA1, SA2, and SA6 
were rated inappropriate because their locations are in the same meridian with the true 
acupoints and touch another acupoint (3 experts). In addition, the pressing technique for 
SA1 was rated as inappropriate by three experts. Among them, two experts indicated 
this pressing technique is wrong and one expert indicated it is easy to stimulating 
Sishencong if using this technique. However, none of the experts who rated 
“inappropriate” provide a reference for their decisions. 

30 
 
Based on the result, Hegu was replaced by Neiguan (PC6).  Neiguan regulates the 
circulation of chi, strengthens the spleen and stomach which resulted in calming the 
mind, restoring clarity to the brain, and improving anxiety, irritability, depression, and 
anxiety (Cross, 2010; Stein, 2009; Young, 2001). The pressing technique for Baihui 
was revised (see table 2). SA1 was relocated to the base of metacarpal bone of the left 
index finger. As such the pressing technique for SA1 was also revised.  The location of 
SA 2 was relocated to 2cm superior to the end of the right eyebrow.   The location of 
SA 6 was relocated to medial malleolus.  
In the second round of the acupressure protocols validation, all the components of the 
true and sham acupressure protocols were determined to be valid, with the validity index 
for each component (C-VI) ranging from 0.83 to 1.00. The validity index for the true 
and sham acupressure protocol (P-VI) also met the satisfactory agreement level with P-
VI was 0.92 and 0.89 respectively (see table 5 and table 6 for more detail). Although 
satisfactory agreement for the true acupressure was achieved among panel, one expert 
held different opinion in term of pressing technique for Baihui. However, the expert did 
not suggest any pressing technique for this acupoint. Four experts suggested to describe 
the pressing technique for Baihui as “using middle or index finger pad firmly massage 
the surrounding area of the acupoints with moderate pressure at rhythm of one second 
per cycle” and for other acupoint expect for Fengchi as “using thumb pad firmly 
massage the surrounding area of the acupoints with rotation movements at rhythm of 
one second per cycle”. After discussing between the doctoral researcher and her 
supervisor and a TCM expert, who both work in acupuncture/acupressure research area, 
the modification was made to revise the pressing technique for true acupressure 
protocol. The process of validation acupressure protocols was therefore completed. The 
revised acupressure protocol is described in table 7  
 
 

31 
 
Table 4. Components of proposed acupressure protocols do not meet the agreement level in the first round of validation study 
Components 
Validation Assessment of the content 
Reason for rating as inappropriate 
I-IV 
Number of 
experts rating 
“very 
appropriate” 
Number of 
experts rating 
“appropriate” 
Number of 
experts rating 
“inappropriate” 
 
 
Section of the true acupoints 
Hegu 
1 
3 
2 
- In order to trigger effect, this point should be 
pressed until it is SORE. And this is not pleasant 
and the subject sure will not be pressing HARD 
enough throughout the entire course of the 
treatment  
- Do provide reason but suggest to using Neiquan 
instead of this acupoint  
0.67 
Location of the sham acupoints 
SA1 (3cm away from Baihui) 
0 
3 
3 
Touches other acupoint  
0.5 
SA2 (3cm away from Yintang) 0 
4 
2 
Touches other acupoint  
0.67 
SA6 
(3 
cm 
away 
from 
Taichong) 
0 
4 
2 
Touches other acupoint  
0.67 
Pressing technique 
For Baihui (using four finger 
pads, gently tap the area of this 
acupoint on the scalp) (Yeung et 
al., 2017) 
3 
1 
2 
Wrong technique  
0.67 
For SA1 (using four finger 
pads, gently tap the area of this 
acupoint on the scalp) 
2 
1 
3 
Wrong technique  
There is a high chance of stimulating Sishencong 
if using this pressing technique  
0.5 

32 
 
Table 5. Result of the true acupressure protocol validation  
Components 
Validation Assessment of the components 
C-VI 
Number of experts rating 
“very appropriate” 
Number of experts 
rating “appropriate” 
Number of experts 
rating valid 
 
True acupressure protocol 
 
 
 
 
Selection of the acupoints 
 
 
 
 
Baihui 
3 
2 
5 
0.83 
Yintang 
2 
4 
6 
1 
Fengchi 
2 
4 
6 
1 
Neiguan 
3 
3 
6 
1 
Shenmen 
5 
1 
6 
1 
Taichong 
1 
5 
6 
1 
Pressing technique 
 
 
 
 
Baihui 
3 
2 
5 
0.83 
Fengchi 
5 
1 
6 
1 
Other acupoints 
4 
2 
6 
1 
Duration of each section 
1 
4 
5 
0.83 
Duration of whole treatment 
3 
2 
5 
0.83 
Frequency 
4 
1 
5 
0.83 
Time for practice self-acupressure 
4 
1 
5 
0.83 
P-VI 
0.92 

33 
 
Table 6. Results of the sham acupressure protocol validation 
Components 
Validation Assessment of the components 
C-VI 
Number of experts rating 
“very appropriate” 
Number of experts 
rating “appropriate” 
Number of experts 
rating valid 
 
Selection of the sham acupoints 
SA 1 
2 
3 
5 
0.83 
SA 2 
2 
4 
6 
1 
SA 3 
3 
2 
5 
0.83 
SA 4 
2 
3 
5 
0.83 
SA 5 
2 
3 
5 
0.83 
SA 6 
2 
4 
6 
1 
Pressing technique 
 
 
 
 
SA 3 
3 
3 
6 
1 
Other acupoints 
4 
2 
6 
1 
Duration of each section 
2 
3 
5 
0.83 
Duration of whole treatment 
4 
1 
5 
0.83 
Frequency 
4 
1 
5 
0.83 
Time for practice self-acupressure 
4 
1 
5 
0.83 
P-VI 
0.89 

34 
 
Table 7. The revised acupressure protocols 
Sequence 
acupoint 
Location  
Pressing technique 
Frequency, 
duration 
True acupressure protocol 
Baihui 
(GV20) 
On the head, 5 B-cun superior to the 
anterior hairline on the anterior median 
line  
using middle or index finger pad firmly 
massage the surrounding area of the 
acupoints with moderate pressure at 
rhythm of one second per cycle. 
3 mins 
Yintang 
(EX-HN3) 
The midpoint between the eyebrows 
using thumb pad, firmly massage the 
surrounding area of this acupoint with 
rotation movements at rhythm of one 
second per cycle. 
3 mins 
Fengchi 
(GB20) 
In the anterior region of the neck, inferior 
to the occipital bone, in the depression 
between the origins of 
sternocleidomastoid and the trapezius 
muscle 
using two thumbs, press in the acupoint 
bilaterally while the other four fingers 
should hold the back of the head 
naturally 
3 mins both 
size at the 
same time 
Neiguan 
(PC6) 
On the anterior aspect of the forearm, 
between the tendons of the palmaris 
longus and the flexor carpi radialis, 2 B-
cun proximal to the palmar wrist crease. 
using thumb pad, firmly massage the 
surrounding area of this acupoint with 
rotation movements at rhythm of one 
second per cycle. 
3 mins for 
each side 
Shenmen 
(HT7) 
On the anteromedial aspect of the wrist, 
radial to the flexor carpi ulnaris tendon, 
on the palmar wrist crease. 
using thumb pad, firmly massage the 
surrounding area of this acupoint with 
rotation movements at rhythm of one 
second per cycle. 
3 mins for 
each side 
Taichong 
(LR3) 
On the dorsum of the foot in the 
depression distal to the junction of the 
first and second metatarsal bones. 
using thumb pad, firmly massage the 
surrounding area of this acupoint with 
rotation movements at rhythm of one 
second per cycle. 
3 mins both 
size at the 
same time 
Sham acupressure protocol 
SA 1 
Base of metacarpal bone of the right 
middle finger 
using thumb pad, firmly massage the 
surrounding area of this acupoint with 
rotation movements at rhythm of one 
second per cycle. 
3 mins 
SA 2 
2 cm superior to the end of the right 
eyebrow 
3 mins 
SA 3 
Mastoid bone 
using two thumbs, press in the acupoint 
bilaterally while the other four fingers 
should hold the back of the head 
naturally 
3 mins both 
size at the 
same time 
SA 4 
Head of ulnar styloid 
using thumb pad, firmly massage the 
surrounding area of this acupoint with 
rotation movements at rhythm of one 
second per cycle. 
3 mins for 
each side 
SA 5 
Base of metacarpal bone of the index 
finger 
3 minutes 
each side 
SA 6 
Medial malleolus 
3 mins both 
size at the 
same time 
Duration of each section: 24 minutes 
 
Duration of whole treatment: 4 weeks (28 days) 
 
Time for practice self-acupressure: Before bedtime (final activities of the day, after practicing acupressure the 
participants should attempt to sleep) 

35 
 
4.5. Methods of the feasibility study 
A Randomized Control Trial study is the golden standard for evaluating the efficacy of 
an intervention since this is the most rigorous method to examine the effectiveness of a 
treatment (Schulz, Altman, & Moher, 2010). This method not only minimizes the 
treatment bias but also control confounding or prognostic factor among groups (Viera 
& Bangdiwala, 2007). However, before running a large-scale trial, there is a need to 
assess the feasibility of the study procedure. Feasibility study generally is used to 
identify possible issues and resolving problems related to the implementation of the trial 
(Hertzog, 2008). A feasibility study is conducted to examine whether the study can be 
done. Therefore, it needs to be conducted to assess the research an intervention process. 
For this reason, a feasibility study designed as a randomized control trial was developed 
to assess the acceptability of the intervention and make estimations about the 
effectiveness of the intervention. 
 4.5.1. The study design 
A feasibility study with three-arms randomized sham-controlled trial will be set up. The 
three arms are the true acupressure group, the sham acupressure group, and the 
enhanced standard care group.  
Managing 
non-specific 
effect 
was 
found 
to 
improve 
the 
reliability 
of 
acupuncture/acupressure treatment (Hrobjartsson & Gotzsche, 2010). The non-specific 
effect is referred to positive change in patient outcomes that are associated with patient’s 
desire for symptom relief (Tough, White, Richards, Lord, & Campbell, 2009), or 
patient’s perceptions of the treatment (Dowrick & Bhandari, 2012), or the 
communication between the therapists and participants (Paterson & Dieppe, 2005). As 
such, the sham acupressure group must be included to serves as a control group to test 
the efficacy of the treatment. In the sham acupressure group, participants will practice 
the same treatment protocol with those in the true acupressure group except for the 
acupoint. In this study, participants in the sham group will stimulate a non-acupoint 
without eliciting deqi sensation. As such, the sham treatment is believed to create no 
therapeutic effect (Xiang, He, & Li, 2018). Therefore, the sham treatment helps to 
distinguish between the specific therapeutic effect and non-specific effect of 

36 
 
acupressure which cannot be managed in the waiting-list control or standard care 
control group. 
The “enhanced standard care” control group must also be included. An enhanced 
standard care control group refers to a group that receives no intervention but standard 
care provided by health professionals and leaflet with some tips to manage insomnia, 
depression, and anxiety provided by the researcher. The enhanced standard care control 
group (ESC) serves as a benchmark, allowing researchers to compare the intervention 
group to the control group to see the changes in the outcomes of the study. It allows 
researchers to assess the effect of the intervention against not receiving treatment during 
that same period. Also, this group also helps to test the size of the non-specific effects 
of the acupressure treatment by comparing the effect of the intervention between sham 
acupressure group and “enhanced standard care” group (Tan et al., 2015). 
For these above reasons, a three-arm trial will be adopted. Specific effects of self-
acupressure will be measured by comparing the patient’s outcomes between the true 
self-acupressure group and sham self-acupressure group. The non-specific effect of the 
treatment will be measured by comparing the patient’s outcomes between the sham self-
acupressure group and the enhanced standard care group. Information about each of the 
three study groups will be detailed in the section 5.3.5. 
4.5.2. Study participants 
The participants are patients receiving chemotherapy at the chemotherapy unit. The 
results from our cross-sectional study indicate insomnia was not correlated with age, 
gender, cancer diagnosis, cancer stage and treatment-related factors, therefore, there are 
no specific inclusion criteria regarding cancer diagnosis, cancer stage, number of chemo 
cycles, and gender. 
Inclusion criteria: 
To be included in the trial, patients have to be: 
- 
Undergoing chemotherapy currently. 
- 
Age 20 – 84 years’ old and legally independent with respect to signing the 
consent form. 

37 
 
- 
Able to read and write Vietnamese (to complete the questionnaires and provide 
informed consent). 
- 
Have Karnofsky score ≥ 80 (to be able to practice self-acupressure). 
- 
Have Insomnia Severity Index score ≥ 11 (as an optimal cutoff point to detect a 
majority of patients with insomnia and this score has obtained sensitivity of 
97.2% and specificity of 100% (M. H. Savard et al., 2005) 
- 
Have Anxiety score measured by HADS ≥ 8 and Depression score measured by 
HADS ≥ 8 (as an optimal cutoff point to detect cases with sensitivity and 
specificity of 90% for both anxiety and depression as shown in the study by 
Bjelland, Dahl, Haug, and Neckelmann (2002). 
Exclusion criteria: 
Patients are excluded from the trial if they: 
- 
Are unable to understand or cooperate with study procedures. 
- 
Are receiving other cancer treatments (e.g., radiotherapy, hormonal therapy) at 
the same time as receiving chemotherapy and during the period of their 
involvement in the trial.  
- 
Are participating in other research studies which may have interacted with the 
current trial or affect insomnia, depression, anxiety perception. 
- 
Have difficulties or are unable to practice self-acupressure by themselves. 
- 
Are receiving insomnia or depression/anxiety treatment currently. 
4.5.3. Trial arms 
There are one group receiving the intervention and two control groups in this study. 
They are the true self-acupressure group, the sham self-acupressure group, and the 
enhanced standard care group. After being evaluated as eligible participants of the 
study, patients will be invited to the study. They will be given information sheet to 
provide more information about the study and the consent form to sign. After that, they 
will be asked to completed baseline assessment and be randomized into study groups.  
The following gives detail on how these three group will be operated (see table 4). 

38 
 
4.5.3.1. True self-acupressure group [Enhanced standard care + True self-
acupressure intervention protocol]:  
Participants in this group will practice the four-week acupressure protocol plus standard 
care. When participants admit hospital to receive chemotherapy treatment, they will 
receive a self-acupressure training section (Detail of training section will be described 
in section 4.5.8).  Participants will be requested to practice acupressure at home once a 
day at night time (before going to bed) for four weeks. During the four weeks treatment, 
participants will receive a weekly phone call follow up from researchers. Enhanced 
standard care for the participants is described in section 4.5.3.3. 
4.5.3.2. Sham self-acupressure group [Enhanced standard care + Sham self-
acupressure intervention protocol]:  
Patients in this group will practice the four weeks sham self-acupressure protocol plus 
standard care. When participants admit hospital to receive chemotherapy treatment, 
they will receive a self-acupressure training section (Detail of training section will be 
described in section 4.5.8).  Participants will be requested to practice sham acupressure 
at home once a day at night time (before going to bed) for four weeks. During the four 
weeks treatment, participants will receive a weekly follow up phone call from 
researchers. Enhanced standard care for the participants is described in section 4.5.3.3. 
4.5.3.3. Enhanced standard care group  
The standard care in potential settings for cancer patients undergoing chemotherapy 
includes health assessment, regular health advices regarding symptoms that patients 
report and nutrition advice during taking chemotherapy treatment. On the first day 
admitted to the hospital,  the patients will receive a health assessment sections by doctor 
and nurses. If the result of the health assessment reflects patients are able to receive 
chemotherapy treatment, the patients will be scheduled to start their chemo-cycles in 
the  following day. During receiving chemotherapy treatment patients will stay in the 
hospital, however with patients who already completed several chemo-cycles can 
choose to stay in the hospital or only come to the hospital to receive the treatment then 
come back home/guess house in the night time. The doctors and nurses also monitor 

39 
 
them during the treatment. After receiving chemotherapy treatment (from one to three 
days), patients will receive another health assessment section by doctor and nurses. In 
this section, health education regarding symptoms that patients report, nutrition advice, 
and schedule for the next chemo-cycle will be included. Afterward, patients are being 
discharged from the hospital and then come back for the next chemo-cycles which are 
delivered three or four weeks apart. There is no standard care for depression and anxiety 
since patients normally do not report these symptoms during the health assessment and 
also these symptoms are not assessed by a healthcare professional when the patients 
admitted to the hospital. Unless the symptoms become so severe that patients give up 
on treatment or attempt suicide, the doctor will refer patients to counseling 
psychological services. The standard care for patients with insomnia in potential 
settings include given hypnotics to patients (Diazepam 5mg) and some tips to help 
patient improve their sleep.  
However, based on the main researcher’s observation, in the potential settings, the 
health education regarding insomnia, depression, and anxiety is provided verbally to the 
patient in a few minute by nurses. And a lot of participants do not received this 
education. This fact can be explained by the hospital overcrowding and shortages of 
nurses in cancer hospital. As such, in this study, apart from the standard care which 
provided by the hospitals, we decide to provide participants a leaflet with 10 
recommendations which help participants manage insomnia, depression, and anxiety. 
These tips includes some basic sleep hygiene rules (Posner, 2011) and tips to manage 
anxiety and depression adapted from Anxiety and Depression Association of American 
(ADAA) website (Anxiety and Depression Association of America, 2018). Below is the 
detail of these recommendations: 
 Take a time-out. Going out, listen to music, or do what ever you like to 
helps clear your head. 
 Eat well-balanced meals. Avoid consuming coffee, alcohol, and nicotine. 
 Exercise daily to help you feel good and maintain your health.  
 When you feel anxiety, take deep breaths. Inhale and exhale slowly. Count 
to 10 slowly. Repeat, and count to 20 if necessary. 

40 
 
 Accept that you cannot control everything. Put your stress in perspective: 
Is it really as bad as you think? 
 Welcome humor. A good laugh goes a long way. 
 Maintain a positive attitude. Make an effort to replace negative thoughts 
with positive ones. 
 Get involved. Volunteer or find another way to be active in your 
community, which creates a support network and gives you a break from 
everyday stress. 
 Talk to someone. Tell friends and family you’re feeling overwhelmed, and 
let them know how they can help you. Talk to a physician or therapist for 
professional help. 
 
 Try to get good sleep by applying the following rules:   
• 
Regular bedtime, arising time or both 
• 
Avoid naps if possible 
• 
Avoid frequent use of bed for non-sleep related activities (e.g. 
watching TV, reading, studying, snacking) 
• 
Avoid mental activities such as thinking, planning, reminiscing, 
etc. to occur in bed. 
• 
Curtail time in bed. If you cannot sleep, you are advised to leave 
the bed, do some other activities such as: reading a book, 
listening to soft music and only come back to bed when you feel 
sleepy. 
• 
Eliminate the noise from the bedroom. 
• 
Have a comfortable pre-bedtime routine (light snack before 
bedtime, comfortable bed mattress, appropriated temperature for 
bed room, comfortable sleep clothes) 
   

41 
 
By providing participants in the study this leaflet, we slightly enhance the standard care 
but do not contaminate the effective of the intervention since these tips are basic and 
participants can easily read about them on the internet or newspaper. In addition, to 
minimize the bias cause by contacting between interventionist and participants, we also 
provide participants in the enhanced standard care group weekly follow up phone call 
in four week (same as participants in the true and sham acupressure group). It will be a 
neutral conversation between the main researcher and the participant in three to five 
minutes. The main research will ask some question such as how is the participant, does 
the participant take any kind of medication to manage their symptom and remind 
participant to come back hospital for the next chemo-cycle on time. During the call, the 
main research will avoid to discuss any kind of management for insomnia, depression, 
and anxiety.  
To summarize, the enhanced standard care in this study refers to standard care provided 
by the hospital includes health assessment, nutrition advice during taking 
chemotherapy treatment, hypnotics (Prescribe only where necessary by a doctor), and 
the enhanced care provided by the main researcher includes patient leaflet of tips on 
managing insomnia, depression, and anxiety; weekly follow-up phone call in four 
weeks. 
Table 8. Detail of provided components in each study arm. 
 
 
 
Study arms 
Detail of provided components 
Acupressure training 
True-self 
acupressure 
follow 
the protocol 
4 Weekly follow – up 
phone call 
Acupressure training 
Sham-self 
acupressure 
follow 
the protocol 
4 Weekly follow – up 
phone call 
Heath assessment 
Nutrition advice 
Hypnotics 
(when 
necessary) 
Patient Leaflet 
4 Weekly follow-up 
phone calls 
True self-acupressure 
group 
 
 
 
Sham self-acupressure 
 
 
 
Enhanced standard care 
 
 
 
 Components are includes in the study arm 

42 
 
4.5.4. Outcomes measurement 
The aim of this feasibility study is to assess the potential for success of implementation 
of an  RCT to test the effectiveness of acupressure in improving a symptom cluster of 
insomnia, depression, and anxiety. Therefore, it does not necessarily need to have a 
primary outcome and secondary outcomes (National Institutes of Health, 2012; Tickle-
Degnen, 2013). As such, the outcomes are regarding the objective of the studies. 
Objective 1: To evaluate recruitment capability. 
- The recruitment rate, the consent rate, and refusal rate will be calculated based 
on the number of screened patients, the eligible patients, the number of eligible 
patients who finally agree to participate in the study, the number of patients 
who sign the informed consent form, reason for ineligibility, refusal, and time  
to recruit enoung participant will be recorded.  
Objective 2: To evaluate the acceptability of the intervention and study procedures 
- The attrition rate will be calculated by the number of participants who decide to 
discontinue the study and the number of participants who are lost to contact 
during the study period. Reason for dropping out and lost to contact will be 
recorded. 
- The adherence rate will be calculated based on the number of participants 
correctly follows the treatment protocol which will be measured by the “Self-
Acupressure Record Form”. Reason for not following the treatment will be 
recorded. 
- The acceptability score of the intervention will be measured by The Intervention 
Rating Profile – 15 (Martens, Witt, Elliott, & Darveaux, 1985). The Intervention 
Rating Profile – 15 (IRP-15) consists of 15 items, each item is rated on a six-
point Likert scale ranging from one (Strongly disagree) to six (Strongly agree). 
The higher score indicated higher acceptability of the intervention. The scale had 
been validated, translated into Vietnamese with high reliability (Cronbach’s α = 
0.89) (Nguyen, Alexander, & Yates, 2018) 
 
 

43 
 
Objective 3: To identify potential adverse events associated with self-acupressure 
- 
Participants will be requested to report potential adverse events related to 
acupressure in the “Self-Acupressure Record Form”. 
Objective 4: To preliminary evaluate the effects of self-acupressure on the severity of 
insomnia, depression, anxiety, and severity of the symptom cluster of these symptoms. 
Insomnia 
As discussed in Chapter 2, subjective (questionnaire) and objective measurements 
(actigraph) are required to measure sleep, but results of the cross-sectional survey in 
Chapter 3 indicated participant’s insomnia severity is not associated with objective 
sleep measures and using objective measurement causes difficulty in subject 
recruitment. Therefore, in this intervention, we use subjective measurement to measure 
sleep among participants.  
The Insomnia Severity Index (ISI) is used to measure insomnia severity among 
participants. This instrument had been validated translated into Vietnamese previously 
(Long, Thanasilp, & Thato, 2016) and was being used in the cross-sectional study with 
high reliability (Cronbach’s α = 0.92). A sleep diary is used to measure sleep 
parameters. The participant will be requested to complete a one-week sleep diary before 
starting practice acupressure, after the treatment period ends, and after. The sleep diary 
is used to measure these sleep parameters: Total Sleep time (minute), total time in bed 
(minute), the number of night awaken after sleep onset and sleep efficiency. Participants 
will be requested to complete the sleep diary when they wake up in the next morning. 
Depression and Anxiety 
The Hospital Anxiety and Depression Scale (HADS) was developed by Zigmond and 
Snaith (1983) to measure depression and anxiety among participants. This instrument 
had been translated into Vietnamese previously (Long et al., 2016)  and was used in the 
cross-sectional study with the Cronbach’s alpha for the scale was 0.87 and for anxiety, 
subscale was 0.86 and for depression, subscale was 0.76. 
The severity of the whole cluster 

44 
 
Separate numerical analog scales (NAS) for each symptom will be used to measure the 
severity of the whole cluster in the previous month. The symptom severity score of each 
of symptom in the cluster will be measured by an 11-point scales with 0 means “not 
present” and 10 means “as bad as it could be”. Symptom severity at the cluster level 
will be evaluated by the averaging symptom severity score of each symptom in the 
cluster. The symptom cluster severity is calculated by the following formula. 
 
𝑺𝒚𝒎𝒕𝒐𝒎 𝒄𝒍𝒖𝒔𝒕𝒆𝒓 𝒔𝒆𝒗𝒆𝒓𝒊𝒕𝒚=
Anxiety score +Depression score +Insomnia score (measured by NAS)
3
   
 
This measuring approach combined multiple outcomes of the study. Such measurement 
is commonly used to detect the combination of intervention effects and assessing the 
symptoms of cancer patient using self-reported outcomes (Freemantle, Calvert, Wood, 
Eastaugh, & Griffin, 2003; Kwekkeboom, 2016).  
Objective 5: To preliminary evaluate the effects of self-acupressure on participants’ 
sleep parameter  
A sleep diary is a useful tool tool for evaluating and tracking insomnia treatment effects 
(Buysse, Ancoli-Israel, Edinger, Lichstein, & Morin, 2006). In this study, the sleep 
diary (SD) which has been developed, standarzied, and validated by 25 insomnia 
experts is used to measure participants’ sleep parameters  (Carney et al., 2012). The 
following sleep parameters will be measured: 
Sleep onset latency (SOL): the length of time that participant takes to accomplish the 
transition from full wakefulness to sleep, 
Total time spend in bed (TSB): is the length of time that participant spend in bed 
Wakefulness after initial sleep onset (WASO): the period of wakefulness occurring after 
sleep onset.  
The number of night awaken after sleep onset. 
Total sleep time (TST): is the length of time that participant spend actually sleeping.  

45 
 
TST (min) = TSB (min) – SOL (min) – WASO (min) 
Sleep efficiency (SE): the ratio of total sleep time to total time spend in bed. 
𝑆𝐸 (%) = TST (min) x 100
TSB (min)
 
Objective 6: To preliminary evaluate the effects of self-acupressure on participants 
‘quality of life. 
The Functional Assessment of Cancer Therapy-General (FACT-G) is used in this study 
to assess the quality of life in participants. This scale measure four domains of quality 
of life: Physical well-being (PWB) the severity of pain also being measured in this 
domain of the questionnaire; Social/family well-being (SWB); Emotional well-being 
(EWB) and Functional well-being (FWB). This instrument has been translated into 
Vietnamese by FACIT system and had been used in the previous study with the 
Cronbach’s alpha for the scale was 0.89 and for Emotional well-being, subscales were 
0.78, FWB = 0.82, PWB = 0.81 and for SWB was 0.82. 
Table 9. Time points for data collection 
 
Screening 
Week 0 
Baseline 
Daily (from 
week 1-4) 
Week 4 
Week 8 
Number of eligible participants 
X 
 
 
 
 
Number of eligible  participants sign 
the informed consent form 
X 
 
 
 
 
Reason for ineligibility, refusal 
X 
 
 
 
 
ISI 
 
X 
 
X 
X 
HADS 
 
X 
 
X 
X 
NAS for each symptom 
 
X 
 
X 
X 
Sleep diary 
 
X 
 
X 
X 
FACT-G 
 
X 
 
X 
X 
Karnofsky performance status scale 
 
X 
 
 
 
Self-Acupressure Record Form 
 
 
X 
 
 
Assessment treatment fidelity 
 
X 
 
X 
 

46 
 
 
4.5.5. Sample size 
Applying the rule of thumb, 30 subjects will be recruited for each study groups as the 
requirement for feasibility study involving between-groups comparisons and effect size 
estimation (Hertzog, 2008; Lancaster, Dodd, & Williamson, 2004). The potential drop-
out rate of 20% is used to calculate the total sample size for the feasibility study. This 
is the drop-out rate of previous similar RCTs using three group design to evaluate the 
efficacy of self-acupressure to reduce symptoms cancer patients (Chung et al., 2015; 
Zick et al., 2016). Therefore, the total sample size will be set at 114 patients with 38 
patients per group. 
4.5.6. Settings 
The study will be conducted in three large oncology hospitals in Vietnam which are the 
Vietnam National Cancer Institute and Hanoi Oncology Hospital. All of them are 
located in Hanoi, the capital of Vietnam. 
(1) Vietnam National Cancer Institute (Hospital A): This is the largest cancer 
hospital in Vietnam, the hospital has 1500 beds and is in charge of providing 
cancer treatments for patients from North and Middle of Vietnam. On average, 
the hospital receives about 1100 patients every day.  The hospital has three 
branches, the data will be collected in the largest branch of the hospital which 
has two chemotherapy units. The A1 chemotherapy unit provides chemotherapy 
treatment for patients diagnosed with breast cancer or gynecologic cancer. The 
A2 chemotherapy unit provides chemotherapy treatment for patients with 
various cancer diagnoses (such as lung cancer, gastrointestinal cancer, Non-
Hopkin lymphoma). These units have 24 wards, 130 beds in total. There are 22 
doctors and 40 nurses. Every day these units received about 160 patients. 
Adverse Events 
 
 
 
X 
X 
IRP-15 
 
 
 
X 
 
Concomitant 
medication 
and 
Supplement 
X 
X 
 
X 
X 

47 
 
(2) Hanoi Oncology Hospital (Hospital C) is a public hospital that is in charge of 
providing cancer treatment for patients in Hanoi. The hospital has 500 beds and 
receives about 300 patients per day. There are two chemotherapy units in this 
hospital. The C1 unit provides chemotherapy treatment for breast cancer patients 
and gynecologic cancer patients. The C2 unit provides the treatment for patients 
with various cancer diagnoses (such as lung cancer, gastrointestinal cancer, Non-
Hopkin lymphoma). There are 120 beds in these units with eight doctors and 24 
nurses. The chemotherapy units provide treatment for approximately 80 patients 
per day. 
The average nurse to patient ratio is quite equal in these settings (approximately from 
1:3 to 1:4). These hospitals are public institutions. Therefore, the standard care for 
cancer patients undergoing chemotherapy has followed the standards of the Vietnam 
Ministry of Health. The quality of staff and health care services among those settings 
are equal. So it can be said that the treatment environment in potential settings is similar. 
4.5.7. Randomization, allocation concealment, and blinding 
4.5.7.1. Randomization and allocation concealment. 
Randomization refers to a method based on chance only by which participants are 
assigned to a trial group. Randomization also helps to ensure the allocation concealment 
which refers to preventing researcher, clinicians, and participants from being known the 
next group assignment and thus influencing group assigning process (Altman, Schulz, 
Moher, & et al., 2001). Randomization is an important component of trial design to 
evaluate the true benefits of treatment since a trial with inadequate and unclear 
concealment of allocation sequence is believed to produce 40% larger estimation of the 
effectiveness of a treatment (Jüni, Altman, & Egger, 2001).  
In this feasibility study, block randomization will be applied to keep the equal size of 
each trial arm. After being recruited in the trial, participants will be randomly assigned 
to three trial groups. 114 participants will be randomized into three study groups in a 
block of six participants. The block size must be the multiplier of the sum of the 
treatment ratio (1:1:1). Therefore the block size must be 3, 6, 9, 12, etc. As such, six is 

48 
 
the size of the block since 114 is divisible by six.  A randomization table will be 
computer 
generated 
by 
using 
the 
online 
randomizer 
at 
https://www.sealedenvelope.com/simple-randomiser/v1/lists. The randomization table 
will be prepared and kept by a researcher in Thanh Tay University who does not involve 
in any research process. After recruiting enough participants for a block, the main 
researcher will send the list of participants’ name to the randomization table keeper. 
The randomization table keeper will then randomly assign participants into trial groups 
based on the prepared randomization table and email the group assignments to the main 
researcher. By using this randomized strategy, the trial meets the criteria to have 
adequate allocation concealment since researchers are unable to predict the group 
allocation until the participants are entered into the study and researchers also are unable 
to change the group allocation after participants are randomized (Vickers, 2006). 
4.5.7.2. Blinding 
Blinding refers to ensure that participants or personnel within a trial are unaware of 
treatment allocation. There are several levels of blinding include single-blind which 
refers to one party of the trial (participants or researchers) is blinded to the treatment 
allocation, double-blind refers to two parties (participants and researchers) are blinded 
to the treatment allocation, and triple-blind refers to three parties of the trial (participant, 
researchers and other staff involved in the trial) are blinded to the treatment allocation 
(Friedman, Furberg, Demets, Reboussin, & Granger, 2015). Blinding design is applied 
to reduce detection bias and performance bias (Probst et al., 2016).  
In this study, due to the nature of the intervention, a partial double-blinded design will 
be employed. Participants randomize in standard care group will know their group 
assignment, but participants randomize to true and sham self-acupressure group will not 
know whether they receive true or sham self-acupressure treatment. Nevertheless, the 
outcomes of the study are all self-reported instruments, therefore, to some extent, the 
participants themselves could be viewed as “outcome assessors”. Therefore, 
participants and “outcome assessors” located in true or sham self-acupressure group 
will be blinded on the treatment allocation. To ensure the successful blinding design, 
healthcare provider working in the wards will not know the group allocation, the main 

49 
 
researcher will also work with the head-nurse of the department to arrange patient in 
intervention group and control groups into different wards.  
4.5.8. Study procedures 
The main researcher will meet with the representative of three potential hospitals (in 
Hanoi, Vietnam) 2 weeks before the commencement of the feasibility study to asking 
for permission to collect the data. Ethical approval memos, a study packet which 
contained study proposal, information sheet, invitation letter, and consent form will be 
given to the representatives of the hospitals.  
Participants from five chemotherapy units will be recruited to the study (two 
chemotherapy units in hospital A, one in hospital B, and two from hospital C). In each 
of the chemotherapy unit, one nurse will be selected to help in screening for eligible 
participants. A subject recruitment training section will be delivered to five nurses who 
help in participant recruitment by the main researcher. On the first day patients admit 
to the hospital, during the health assessment, nurses will ask the patients to rate the 
severity of insomnia, depression and anxiety that they experience during the previous 
month. Each of the symptom will be measured by separate Numerical Analog Scales 
(NAS). NAS is an 11-point scales with 0 means “not present” and 10 means “worst 
possible”. If the patients rate 4 or above for their insomnia, depression, and anxiety 
nurses will inform the main researcher and introduce the potential patient to the main 
researcher. The main researcher will introduce the study in detail to potential 
participants and give them the information sheet. The information sheet provides brief 
and clear information on the essential elements of the study: the aim of the study, the 
study procedure, the voluntary of involvement, participant rights, and potential risks, 
and contact information. The researcher will give participants time to read the 
information sheet and decide whether the study is of interest to them and whether they 
want to discuss it further. Participants can ask researcher any questions related to the 
study. If the potential participants agree to participate in the study, they will be given 
the informed consent form to sign. After signing the consent form, researchers will 
collect the demographic data of participants and instruct participants to complete the 
baseline assessment (ISI, HADS, FACT-G). After the participants complete the 

50 
 
baseline assessment, the main researcher will summarize the result and if the 
participants is eligible for the trial they will be instructed how to complete the seven 
days sleep diary after they discharge from the hospital. Afterward, participants will be 
randomly assigned to one of the following groups: the true self-acupressure group 
(TSA), the sham self-acupressure group (SSA) and enhanced standard care group 
(ESC). Subject recruitment, baseline assessment, and randomization will be completed 
on the first or second day participants admit to the hospital to receive chemotherapy 
treatment. Training participants section will be scheduled on the same day or one day 
after participants finish baseline assessment based on the availability of participants and 
interventionist. Sleep diary will be completed in the first week after participants 
discharge from the hospital. 
Participant in the true self-acupressure group or sham self-acupressure group 
Participants in these group will either receive a true self-acupressure or sham 
acupressure training section based on their group assignment. Participants will be 
requested to practice acupressure at home for four weeks after they complete the sleep 
diary baseline assessment (a telephone reminder will be made). During the four weeks 
treatment, participants will receive a weekly phone call from researchers for 
encouraging to practice acupressure and answer inquiries may have. During this period, 
participant will be requested to complete Self-acupressure record form every day. After 
four weeks treatment, participants will be asked to complete and send back all the post-
intervention assessing questionnaire to research by express service (Insomnia Severity 
Index [ISI], Hospital Anxiety and Depression Scale [HADS], FACT-G, Sleep Diary 
[SD], Self-acupressure Record Form, and Intervention Rating Profile 15 [IRP-15]). A 
short-term follow up will be then carried out in four weeks to assess the persistence 
effect of acupressure on the symptoms outcome.  During this time, the patient will not 
practice acupressure at home. By the end of follow up time, researchers will make a 
telephone reminder to participants and ask them to complete and send back all the 
follow-up assessment questionnaire to the main research by express service (ISI, 
HADS, FACT-G, sleep diary). 200,000 vnd (equal to 60 HKD) will be given to 
participants for the express service charge by the end of the follow-up time. 

51 
 
Participants in the enhanced standard control group  
Participants in the enhanced standard control group will receive the leaflet with tips to 
manage insomnia, depression, and anxiety. Weekly telephone reminder will also be 
made in four week. By the end of week fourth, participants in this group will be 
requested to complete post-intervention assessment and send back to research by post  
(ISI, HADS, FACT-G, SD). A short-term follow up will be then carried out in 4 weeks. 
During the follow-up period, participants receive no weekly telephone reminder. By the 
end of follow up time, researchers will make a telephone reminder to participants and 
ask them to complete and send back all the follow-up assessment questionnaire to 
research by express service (ISI, HADS, FACT-G, SD). 200,000 vnd (equal to 60 HKD) 
will be given to participants for the express service charge by the end of the follow-up 
time. The procedure of the feasibility study is depicted in Figure 5 depicts the main 
study procedures.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participants recruit 
Baseline assessment  
(ISI, HADS, FACT-G) 

52 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TSA: True self-acupressure, SSA: Sham acupressure, ESC: Standard care 
Figure 5. The flowchart of the study 
 
 
4.5.8.1. Training of Subject recruitment 
Five nurses will be recruited for subject recruitment. Nurses who work in potential 
chemotherapy units with at least one year of experience in working with cancer patients 
Randomization 
TSA group  
SSA group  
ESC group  
Patients receive training section and complete the 7 
days sleep diary.  
Week 1-4:  Patients practice self-acupressure at 
home. Weekly telephone reminders will be made.  
Patients complete Self-acupressure form everyday. 
Patients receive the leaflet and complete 
the 7 days sleep diary.  
Assessment at post intervention (ISI, HADS, FACT-G, Sleep diary, IRP-15) 
Follow up 
Assessment after follow up time 
(ISI, HADS, FACT-G, Sleep diary) 
Data analysis 
Receiving weekly phone call follow up 
Follow up 
Assessment after follow up time 
(ISI, HADS, FACT-G, Sleep diary) 
 
Week 0 
Week 1-4 
End of week 
4th  
Week 5-8 

53 
 
will be recruited. The main researcher will conduct a subject recruitment training 
section with these nurses. The main research will briefly explain the purpose of the 
study and study procedures to nurses then instruction them the screening questions and 
how to complete and score the Insomnia Severity Index (ISI) and Hospital Anxiety and 
Depression Scale (HADS).  
4.5.8.2. Training of the interventionists 
Six nurses will be trained to become interventionists for the study (2 nurses/hospital). 
Nurses who work in potential hospitals with at least two years experience in working 
with cancer patients will be recruited as interventionists of the study. A one hours 
training section (TOT section) will be delivered by the main researcher and a TCM 
professional. The TCM professional is a senior lecturer of Traditional Medicine 
Department, Hanoi Medical University with seven years of experience in teaching, 
practicing and conducting research on acupuncture/acupressure.  
The TOT section consists of two parts. In the first part of the TOT section, the main 
researcher will briefly introduce the main study proposal include the rationale for 
conducting this study, the study aim and objectives, study protocol and outcomes 
measurement. In the second part, the TCM professional will instruct the participants 
how to locate and stimulate acupoint following the acupressure protocols. By the end 
of the TOT sections, the TCM professional will check the mastery of participant’s 
acupressure technique by using Interventionist Skill Checklist for Acupressure and 
Sham Acupressure (See Appendix 6). If wrong location or technique is given, further 
instructions will be made until all of the participants clearly know how to locate and 
stimulate acupoint as indicated in the acupressure protocol. By the end of TOT section, 
a copy of all slides and acupressure protocols will be given to participants.  
4.5.8.3. Training of the participants in the true self-acupressure group and sham self-
acupressure group: 
Participants locate in these groups will receive education section. The training will be 
conducted in a group of three to five patients in 45 minutes. The self-acupressure 
training section will take place in the consultation room in the chemotherapy unit. In 
the education section, interventionists will instruct the participants how to locate and 

54 
 
stimulate acupoint following the acupressure protocols. After giving instruction and 
time for participants to practice, interventionists checks the patient’s mastery of self-
acupressure technique by using the Acupressure Skill Check form for participants 
(Appendix 7). If the participant fails to identify the acupoint or stimulate the acupoint 
wrongly, the interventionist will then correct them. By the end of education section, a 
patient booklet includes step by step guideline with images-illustrating acupressure 
protocol will be given to participants.  
4.5.9. Fidelity of the study 
Fidelity of the intervention referred to strategies to ensure the intervention is 
implemented as planned (Bellg et al., 2004). Basic aspects of treatment fidelity are 
intervention design, intervention training, and receipt of intervention (Murphy & 
Gutman, 2012). Strategies to ensure the fidelity of this study will be listed in each of 
the above aspects. 
4.5.9.1. Intervention design 
For this aspect, a study protocol has been developed, the detail acupressure intervention 
was described in detail including the location of acupoints, acupressure technique, dose 
of the intervention. Potential setbacks and solutions are listed below: 
- Provider dropout: six nurses will be trained to be instructors to deliver 
acupressure training sections. Three of them will be the main instructors and 
others will be extra instructors. The main instructor will be in charge of 
delivering the training sections when they are not available the extra instructor 
will replace them.   
- Lost to follow up due to not available phone number: In order to keep contact 
with participants during the study period, at least two kind of phone number will 
be recorded: the participant’s mobile phone, the participant’s fixed line numbers 
and mobile phone of a member in participant’s family. Participants will also be 
given the name card of the main researcher.  
- To ensure the fidelity of outcome measurements, participants will be instructed 
how to complete the questionnaires and sleep diary. Telephone reminder will 
also be made to remind participants complete and send back the follow-up 

55 
 
questionnaire to the main researcher. Enveloped with the address of the main 
researcher will be provided to participants. If there is still no reply from 
participants after the first telephone reminder, the second ones will be made five 
days later. 
- To ensure equivalent dose across conditions: To ensure the equal number of 
contacts for each intervention arms to minimizer potential therapeutic effects of 
the sham acupressure method and placebo effect of the treatment, patients in 
control groups will also receive the training in same length and enthusiasm as in 
the intervention group. 
4.5.9.2. Intervention training 
Training interventionists 
A training section will be conducted. Six nurses will be trained to become 
interventionists for the study (2 nurses/hospital). A one hours training section (TOT 
section) will be delivered by the main researcher and a TCM professional. The TOT 
section consists of two parts. In the first part of the TOT section, the main researcher 
will briefly introduce the main study proposal include the rationale for conducting this 
study, the study aim and objectives, study protocol and outcomes measurement. In the 
second part, the TCM professional will instruct the participants how to locate and 
stimulate acupoints following the acupressure protocols. Nurses will be given time to 
practice. By the end of the TOT sections, the TCM professional will check the mastery 
of participant’s acupressure technique by using Interventionist Skill Checklist for 
Acupressure and Sham Acupressure. If wrong location or technique is given, further 
instructions will be made until all of the participants clearly know how to locate and 
stimulate acupoint as indicated in the acupressure protocol. By the end of TOT section, 
a copy of all slides and an images-illustrating acupressure protocol will be given to 
participants for references.  
To ensure the TOT section run smoothly, the researcher will provide comfortable 
environment and facilities for the TOT section. The rooms will be convenient to reach, 
keep quiet and clean, equipped with necessary furnitures, such as comfortable chairs, 
table, air condition, refreshments.  

56 
 
Maintaining consistency of delivering intervention among six interventionists 
To ensure consistency of delivering of intervention among interventionist, following 
plans will be implemented. A protocol for self-acupressure training section (for 
participants) is also developed and interventionists are requested to follow this protocol 
when delivering the training to participants (please see Appendix 5 and Appendix 8). 
To ensure the training sections are implemented in the same manner, the researcher 
will monitor at least 80% of training sections. If there are any problems occur, the 
researcher will discuss with the instructor. 
Participant training 
The self-acupressure/sham acupressure training will be conducted in a small group 
(three to five participants). Participants will be given training how to perform the 
acupressure specific to the protocol for their group assignment. To ensure the training 
sections run smoothly, the researcher will provide comfortable environment and 
facilities. The rooms will be convenient to reach, keep quiet and clean, equipped with 
necessary furniture, such as comfortable chairs, table, air condition, refreshments.  
4.5.9.3. Receiving the interventions 
Maintaining treatment fidelity during self-administration of the intervention 
Participants are expected to perform self-acupressure daily following the treatment 
protocol. To enhance and monitor the participant’s adherence to the treatment as well 
as to answer any question during the study period, weekly telephone reminder will be 
made and contact information is also provided to participants. Participants will be 
requested to record their acupressure section on the intervention log during the 
treatment period. Participant also has a follow-up visit with interventionist when they 
admit to hospital for their next chemo-cycles (approximately 3 to 4 weeks after the 
training section). During the visit, the interventionist will check the patient’s mastery of 
self-acupressure technique by using the Acupressure Skill Check Form. The ability of 
participants to perform the intervention will be evaluated with the goal of maintaining 
at least 80% accuracy on the Acupressure Skill Check Form.  

57 
 
4.5.10. Ethical consideration 
Before collecting data, the proposal of study will be submitted for ethical approval from 
Human Subjects Ethics Sub-committee of The Hong Kong Polytechnic University and 
Vietnamese Ministry of Health. Potential participants are invited to participate in the 
study by the main researcher. Information regarding study aims and objective, the study 
procedures, and potential risks of acupressure will be explained by the main researcher. 
The information sheet will be given to potential participants. The information sheet is 
designed to explain the purpose and procedure clearly and as a way to obtain 
participant’s consent in written form. The rights of participants, data privacy protection 
procedures and method of seeking assistance or further information and so on will be 
included. Potential participants will be given time to read the information sheet and ask 
any question regarding the study before deciding on taking part in the study or refuse. 
If the participant decides to take part in the study, written informed consent forms will 
be obtained accordingly. This study has followed the ethical principles for research that 
involves human subjects which are: autonomy, beneficence, non-maleficence, and 
confidentiality (Beauchamp, 2009). 
Autonomy 
The principle of autonomy refers to the right for participants to make their own choice 
of participating in the study (Beauchamp, 2009). In this study, potential subjects will be 
informed the purpose, objectives, study procedures, and potential harms of acupressure. 
This such information is also written in the information sheet which is provided to 
potential participants. Voluntary participation will be assured, and participants will be 
assured the services that they receive will not be affected by their decision of 
participating or not participating as well as withdraw from the study. Participants will 
also be informed about the right to withdraw from the study at any time without any 
harm.  
Beneficence 
The principle of beneficence refers to a concept in research ethics which indicates that 
researcher should have the welfare of the subject as a goal of clinical trial (Beauchamp, 

58 
 
2009). In this study, we use acupressure to manage symptom cluster in participants. 
This treatment is a non-pharmacological, non-invasive treatment with evident its safety 
and effectiveness in managing different symptoms (Lee, Frazier, Lee, & Frazier, 2011; 
H. J. Song et al., 2015; Waits et al., 2016; Yeung et al., 2012a).  
Non-maleficence 
The non-maleficence principle indicates the intervention should not put subjects in any 
harm (Beauchamp, 2009).  In this study, we use a sham acupressure group as a control 
group. The purpose of having this sham group is to test the placebo effect of the 
intervention which is acceptable to determine the efficacy of an intervention (World 
Medical Association, 2018). We decide to choose the using of non-acupoints approach 
for sham-acupressure. Pressing non-acupoints cannot produce any therapeutic effects. 
Therefore, this approach creates no harm for participants.  
Confidentiality  
To ensure subject confidentiality, the following steps will be taken:  
- Personal information of the participants is replaced with research identification 
code - Access to master code lists for key code is limited to only main researcher 
and research assistance.  
- Contact list, recruitment records or other documents that contain personal 
information of the participants are destroyed when no longer required for the 
research ( 3 years after finishing data collection) 
- Files containing electronic data are password-protected and encrypted (at least 
when data are transferred or transported).  
- Research data are stored securely in locked cabinets.  
- Electronic data are stored on password-protected computers or files.  
- Files containing electronic data are closed when computers will be left 
unattended. 
- Consent forms are stored securely in locked cabinets, separately from the 
research data.  

59 
 
Ethical concern regarding paying participants 
Paying for human subjects for participating in scientific research is a common practice 
that has been reported for over 100 years (Levine, 1979). Several ethical concerns have 
been raised regarding this issue, among which, coercion is considered as the most 
common concern (Grady, 2005). However, in this study, the amount of 60 HKD given 
to participant cannot be considered as “paying for participation” since the purpose of 
the payment is for express mail service to return the outcomes assessment forms to the 
main researcher. As such, this payment does not attract or motive participant to the 
study. Therefore, it is acceptable to give 60 HKD to participants in this study. 
Ethical concern regarding not informing participants about their group allocation 
In this study, we do not inform participant in the true acupressure group and sham 
acupressure about their group allocation. They will be informed that the study is 
conducted to compare the effectiveness of two acupoint sets.  One set is similar to the 
acupressure treatment of Chinese Traditional Medicine, and the other set does not 
follow the theory of TCM but has been associated with improvement of insomnia, 
depression, and anxiety. This explanation helps to maintain the blinding design of the 
study. However, by informing participants in this way, the researcher does not tell the 
truth to participant which is unethical in some aspects. However, in qualitative research 
on participant’s views of not informing potential participant about their group 
allocation, Hughes et al. (2014) indicated that participants’ perceive this approach as 
being acceptable. Nevertheless, testing placebo effect is acceptable, and the sham 
acupressure method used in this study does not create any harm to participant’s health. 
As such, we believe it is acceptable to not informing participants in the true and sham 
acupressure group about their group allocation.  
4.5.11. Data Analysis 
Data will be checked for normality, outliers, and missing data. Intention to treat 
principle is adapted for analyzing the result of the pilot study which use the “last value 
carried out forward” approach to replace missing data. This strategy has been widely 
used in analysis RCTs.  Furthermore, it is proved that measuring the effectiveness of 

60 
 
trial may be biased without performing an intention to treat analysis (Hollis & 
Campbell, 1999). Descriptive statistics will be used to analyze the sample 
characteristics, demographics, and data related to the intervention feasibility, 
acceptability and adverse event of acupressure.  Baseline differences among the three 
groups will be compared by chi-square test and repeated measure ANOVA. In case the 
chi-square test is not appropriated because of low cell counts (≤ 5), it will be replaced 
by Fisher’s exact test. The effect size will be calculated by Cohen d based on the mean 
difference between baseline and end of the treatment period for each symptom and the 
cluster of insomnia, depression, and anxiety in the true self-acupressure group and sham 
acupressure group. The significance level is set ai 0.05, therefore if the p-value is less 
than 0.05 the result would be considered significant. IBM SPSS 20.0 will be used for 
data analysis. 
4.6. Potential implication of the study 
Potential implication for nursing research 
As discussed before, the clinical evidence for self-treatment for sleep-related symptom 
cluster is limited and not convincing due to methodological flaws in currently 
published studies. The finding of this study will provide evidence on the effectiveness 
of self-treatment for managing symptom cluster in cancer patients undergoing 
chemotherapy. 
Acupressure treatment obvious benefit to treating single cancer symptoms, however, 
limited studies with rigor design have been conducted to test the effectiveness of this 
treatment in improving symptom cluster. As such, the finding of this study will 
provide evidence on the effectiveness of acupressure for managing symptom cluster in 
cancer patients undergoing chemotherapy. 
The potential implication for nursing practice  
The study offers an invasive treatment at low-cost and safety for patients to manage 
insomnia, depression, and anxiety at home. Nurses in hospital or community setting 
can teach patients about these treatments. With self-acupressure patients can practice 
at home without the need for frequent healthcare worker visit as well as paying money 

61 
 
which reduces patient’s burdens to a larger extent. Nevertheless, the study also 
prompts awakeness to oncologists to the potential of acupressure to relieve cancer-
related symptom clusters.  
 

62 
 
4.7. Proposed timeline for the study 
 
 Study Plan 
08/2018 
09/2018 
10/2018 
11/2018 
12/2018 
01– 06/2019     
07/2019 – 
08/2019 
09/2019 
Ethical approval (from 
PolyU and Vietnamese 
MOH) 
  
  
  
  
  
  
  
  
Sending the proposal to the 
hospitals for approval 
  
  
  
  
  
  
  
  
Conducting the feasibility 
study 
 
 
 
 
 
 
 
 
Data analysis 
 
 
 
 
 
 
 
 
Presenting findings 
  
  
  
  
  
  
  
  

63 
 
4.8. Estimated Budget for study 
Cost item 
Activity/Description 
Estimated expenditure 
(HKD) 
 (a) 
Return air ticket (Vietnam Airlines), including airport taxes. 
Departure :                             ; Return: 
3500 
(b) 
Ethical approval fee (for the feasibility study in 
Vietnam) 
3300 
(c) 
Printing Booklet (include tips to manage insomnia, 
depression, and anxiety; acupressure protocol, sleep 
diary, and acupressure report form) 
3420 
(d) 
Printing questionnaires (for the feasibility study) 
2394 
(e) 
Printing information sheet and consent form (for the 
feasibility study) 
228 
(f) 
Allowance for researcher assistants for the main study (three 
person at 40HKD per person per hour for 180 hours) 
7200 
(g) 
Allowance for Interventionist (three persons at 100HKD per 
person per section for 30 sections) 
3000 
(h) 
Miscellaneous (telephone service fee) 
3000 
(i) 
Payment for participants (for express service) 
6840 
Sub-total 2 
32,882 
Total estimated expenditure (Sub total 1 + subtotal 2)  
32,882 
 
 

64 
 
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71 
 
Appendix 1. Assessment and Evaluation form (English and Vietnamese version) 
THE HONG KONG POLYTECHNIC UNIVERSITY 
SCHOOL OF NURSING 
 
Date: ______________________  
 
 
 
Code: ______________________ 
Hospital____________________ 
 
 
 
Department: ________________ 
Part 1. Demographic data 
Q1: Age: ............................................................................................................................... 
Q2: Gender:           1. Male              2. Female 
Q3: Occupation:  .................................................................................................................. 
Q4: Education: ..................................................................................................................... 
Q5: Marital status: 1. Single            2. Married             3. Divorced                 4. Widowed 
Part 2. Health history 
Q6: Diagnosis:  .................................................................................................................... 
Q7: Time from diagnosis: .................................................................................................... 
Q8: Number of cycle completed: ......................................................................................... 
Q9: Tumor removal surgery before:    1. No                 2. Yes 
Q10: Type of Chemotherapy received: ................................................................................ 
Q11: How Chemotherapy is given ....................................................................................... 
Q12: Given Chemotherapy Regiment: ................................................................................ 
 .............................................................................................................................................. 

72 
 
Part 3. Insomnia Severity Index 
For each question, please CIRCLE the number that best describes your answer. 
Please rate the CURRENT SEVERITY of your insomnia problem(s) in the last 2 weeks. 
Insomnia Problem 
None 
Mild 
Moderate 
Severe 
Very severe 
1. Difficulty falling asleep 
 
 
 
 
 
2. Difficulty staying asleep 
 
 
 
 
 
3. Problems waking up too early 
 
 
 
 
 
4. How SATISFIED/DISSATISFIED are you with your CURRENT sleep pattern? 
Very satisfied 
Satisfied 
Moderately satisfied 
Dissatisfied 
Very Dissatisfied 
0 
1 
2 
3 
4 
5. How NOTICEABLE to others do you think your sleep problem is in terms of impairing 
the quality of your life? 
Not at all 
Noticeable 
A Little 
Somewhat 
Much 
Very Much 
Noticeable 
0 
1 
2 
3 
4 
6.How WORRIED/DISTRESSED are you about your current sleep problem? 
Not at all 
Worried 
A Little 
Somewhat 
Much 
Very Much 
Worried 
0 
1 
2 
3 
4 
7. To what extent do you consider your sleep problem to INTERFERE with your daily 
functioning (e.g. daytime fatigue, mood, ability to function at work/daily chores, 
concentration, memory, mood, etc.) CURRENTLY? 
Not at all 
Interfering 
A Little 
Somewhat 
Much 
Very Much 
Interfering 
0 
1 
2 
3 
4 
Add the scores for all seven items (questions 1 + 2 + 3 + 4 + 5 +6 + 7) = _______  
Total score categories: 
1. No clinically significant insomnia (0-7) 
2. Subthreshold insomnia (8-14) 
3. Clinical insomnia (moderate severity) (15-21) 
4. Clinical insomnia (severe)  (22-28) 

73 
 
 
Part 4. Assessment depression and Anxiety 
Hospital Anxiety and Depression Scale (HADS) 
Cycle beside the reply that is closest to how you have been feeling in the past week. 
Don’t take too long over you replies: your immediate is best. 
Section 1. Anxiety 
No 
Questions 
Answer 
Score 
1 
I feel tense or 'wound up': 
a) Most of the time 
b) A lot of the time 
c) From time to time, occasionally 
d) Not at all 
 
2 
I get a sort of frightened feeling as if 
something awful is about to happen 
a) Very definitely and quite badly 
b) Yes, but not too badly 
c) A little, but it doesn’t worry me 
d) Not at all 
 
 
3 
Worrying thoughts go through my mind 
a) A great deal of the time 
b) A lot of the time 
c) From time to time, but not too 
often 
d) Only occasionally 
 
4 
I can sit at ease and feel relaxed 
a) Definitely 
b) Usually 
c) Not Often 
d) Not at all 
 
 
5 
I get a sort of frightened feeling like 
“butterflies” in the stomach 
 
a) Not at all 
b) Occasionally 
c) Quite often 
d) Very often 
 
6 
I feel restless as I have to be on the 
move: 
a) Very much indeed 
b) Quite a lot 
c) Not very much 
d) Not at all 
 
7 
I get sudden feeling of panic 
a) Very often indeed 
b) Quite often 
c) Not very often 
d) Not at all 
 
. 
Total Score of Anxiety assessment 
 
 
 

74 
 
 
 
Section 2. Depression 
No 
Questions 
Answer 
Score 
1 
I still enjoy the things I used to 
enjoy: 
a) Definitely as much 
b) Not quite so much 
c) Only a little 
d) Hardly at all 
 
2 
I can laugh and see the funny side of 
things 
a) As much as I always could 
b) Not quite so much  
c) Definitely not so much now 
d) Not at all 
 
 
3 
I feel cheerful 
a) Not at all 
b) Not often 
c) Sometimes 
d) Most of the time 
 
4 
I feel as if I am slowed down 
a) Nearly all the time 
b) Very often 
c) Sometimes 
d) Not at all 
 
5 
I have lost interest in my appearance 
a) Definitely 
b) I don’t take as much care as I 
should 
c) I may not take quite as much care 
d) I take just as much care as ever 
 
6 
I look forward with enjoyment to 
things: 
a) As much as I ever did 
b) Rather less than I used to 
c) Definitely less than I used to 
d) Hardly at all 
 
7 
I can enjoy a good book or radio or TV 
program: 
a) Often 
b) Sometimes 
c) Not often 
d) Very seldom 
 
. 
Total Score of Depression assessment 
 
 
 
 
 
 

75 
 
 
Part 5. Assessment Quality of Life 
Functional Assessment of Cancer Therapy – General 
Please circle or mark one number per line to indicate your response as it applies to the past 
7 days 
Code Question 
Not 
at all 
A 
little 
bit 
Some
what 
Quite 
a bit 
Very 
much 
GE1 
I feel sad 
0 
1 
2 
3 
4 
GE2 
I am satisfied with how I am coping with my illness 
0 
1 
2 
3 
4 
GE3 
I am losing hope in fight against my illness 
0 
1 
2 
3 
4 
GE4 
I feel nervous 
0 
1 
2 
3 
4 
GE5 
I worry about dying 
0 
1 
2 
3 
4 
GE6 
I worry that my condition will get worse 
0 
1 
2 
3 
4 
 
 
 
 
 
 
 
GF1 
I am able to work (include work at home) 
0 
1 
2 
3 
4 
GF2 
My work (include work at home) is fulfilling 
0 
1 
2 
3 
4 
GF3 
I am able to enjoy life 
0 
1 
2 
3 
4 
GF4 
I have accepted my illness 
0 
1 
2 
3 
4 
GF5 
I am sleeping well 
0 
1 
2 
3 
4 
GF6 
I am enjoying the things I usually do for fun 
0 
1 
2 
3 
4 
GF7 
I am content with the quality of my life right now 
0 
1 
2 
3 
4 
 
 
 
 
 
 
 
GP1 
I have a lack of energy 
0 
1 
2 
3 
4 
GP2 
I have nausea 
0 
1 
2 
3 
4 
GP3 
Because of my physical condition, I have trouble 
meeting the needs of my family 
0 
1 
2 
3 
4 
GP4 
I have pain 
0 
1 
2 
3 
4 
GP5 
I am bothered by side effect of treatment 
0 
1 
2 
3 
4 
GP6 
I feel ill 
0 
1 
2 
3 
4 
GP7 
I am forced to spend time in bed 
0 
1 
2 
3 
4 
 
 
 
 
 
 
 
GS1 
I feel close to my friends 
0 
1 
2 
3 
4 
GS2 
I get emotional support from my family 
0 
1 
2 
3 
4 
GS3 
I get support from my friends 
0 
1 
2 
3 
4 
GS4 
My family has accepted my illness 
0 
1 
2 
3 
4 
GS5 
I am satisfied with family communication about my 
illness 
0 
1 
2 
3 
4 
GS6 
I feel close to my partner (or the person who is my 
main support) 
0 
1 
2 
3 
4 
Q1 
Regardless of your current level of sexual activity, 
please answer the following question. If you 
prefer not to answer it, please mark this box    
And go to the next section 
 
 
 
 
 
GS7 
I am satisfied with my sex life 
0 
1 
2 
3 
4 
 

76 
 
 
Part 6. Assessment the severity of the cluster of insomnia, depression, and anxiety 
 
For each of the following symptoms, please circle the number which is best describe rate the 
severity of the symptom that you experienced during the previous month. 
 
Insomnia  
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Not  
present     
 
 
 
 
 
 
 
 
 
As bas as 
it could 
be 
  
 
 
Depression 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Not  
present   
 
 
 
 
 
 
 
 
 
As bas 
as it 
could be 
 
 
Anxiety 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Not  
present   
 
 
 
 
 
 
 
 
 
As bas 
as it 
could be 

77 
 
 
Part 7. Sleep diary 
Instruction: The sleep diary must be complete every day. If possible, please complete within one hour of getting out of bed in the morning. If you forget to fill in 
the diary or are unable to finish it, leave the diary blank on that day. If your sleep or daytime functioning is affected by some unusual events (such as illness, or 
an emergency) please make brief notes on your diary.  
Item Instructions Use the guide below to clarify what is being asked for each item of the Sleep Diary.  
Date: Write the date of the morning you are filling out the diary.  
1. What time did you get into bed? Write the time that you got into bed. This may not be the time that you began “trying” to fall asleep.  
2. What time did you try to go to sleep? Record the time that you began “trying” to fall asleep.  
3. How long did it take you to fall asleep? Beginning at the time you wrote in question 2, how long did it take you to fall asleep.  
4. How many times did you wake up, not counting your final awakening? How many times did you wake up between the time you first fell asleep and your final 
awakening?  
5. In total, how long did these awakenings last? What was the total time you were awake between the time you first fell asleep and your final awakening. For 
example, if you woke 3 times for 20 minutes, 35 minutes, and 15 minutes, add them all up (20+35+15= 70 min or 1 hr and 10 min).  
6. What time was your final awakening? Record the last time you woke up in the morning.  
7. What time did you get out of bed for the day? What time did you get out of bed with no further attempt at sleeping? This may be different from your final 
awakening time (e.g. you may have woken up at 6:35 a.m. but did not get out of bed to start your day until 7:20 a.m.)  
8. Comments If you have anything that you would like to say that is relevant to your sleep feel free to write it here. 
 
 

78 
 
SLEEP DIARY 
Name of participant: ………………………………………………………………Age: 
…………………….Hospital:…………………. 
Code: ………………………………………………………………………………………………………………………………………….. 
Today’s date 
Day 1 
Day 2 
Day 3 
Day 4 
Day 5 
Day 6 
Day 7 
 
 
1. What time did you 
get into bed? 
 
 
 
 
 
 
 
2. What time did you 
try to go to sleep? 
 
 
 
 
 
 
 
3. How long did it take 
you to fall asleep? 
 
 
 
 
 
 
 
4. How many times did 
you wake up, not 
counting your final 
awakening? 
 
 
 
 
 
 
 
5. In total, how long did 
these awakenings last? 
 
 
 
 
 
 
 
6. What time was your 
final awakening? 
 
 
 
 
 
 
 
7. What time did you 
get out of bed for the 
day? 
 
 
 
 
 
 
 
8. Comments  
 
 
 
 
 
 
 
 
 
 
 
 

79 
 
Part 8. Self-Acupressure Record Form 
 
Name of participant: ………………………………………………………………Age: 
…………Hospital:……………… 
Code: …………………………………………………………………………………………………………………………… 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
 
11 
 
12 
 
13 
 
14 
 
Number of 
acupoint 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Treatment 
time (min) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Reason for 
not 
practicing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Adverse 
events 
related to 
acupressure 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other self-care methods in insomnia, depression, anxiety:  
 
Any self-taken Chinese Herb/Western medication/supplement: 
 
Drug/supplement name: (1) Dose:…………………………………………………………………… 
                                       (2)  Dose:……………………………………………………………………. 

80 
 
 
Part 8. Self-Acupressure Record Form 
Name of participant: ………………………………………………………………Age: 
…………Hospital:……………… 
Code: …………………………………………………………………………………………………………………………… 
 
15 
 
16 
 
17 
 
18 
 
19 
 
20 
 
21 
 
22 
 
23 
 
24 
 
25 
 
26 
 
27 
 
28 
 
Number of 
acupoint 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Treatment 
time (min) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Reason for 
not 
practicing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Adverse 
events 
related to 
acupressure 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other self-care methods in insomnia, depression, anxiety:  
 
Any self-taken Chinese Herb/Western medication/supplement: 
 
Drug/supplement name: (1) Dose:…………………………………………………………………… 
                                       (2)  Dose:…………………………………………………………………….

81 
 
TRƯỜNG ĐẠI HỌC BÁCH KHOA HỒNG KONG 
KHOA ĐIỀU DƯỠNG 
 
Ngày: ______________________   
 
 
Mã: ______________________ 
Bệnh viện: __________________ 
 
 
 
Khoa:_____________________ 
Phần 1. Thông tin cá nhân 
Q1: Tuổi: .............................................................................................................................. 
Q2: Giới:           1. Nam              2. Nữ 
Q3: Nghề nghiệp:  ................................................................................................................ 
Q4: Trình độ học vấn: .......................................................................................................... 
Q5: Hôn nhân: 1. Độc thân            2. Kết hôn             3. Li dị                 4. Góa 
Phần 2. Bệnh sử 
Q6: Chẩn đoán:  ................................................................................................................... 
Q7: Thời gian mắc bệnh: ..................................................................................................... 
Q8: Số chu kỳ hóa chất đã hoàn thành: ............................................................................... 
Q9: Đã phẫu thuật loại bỏ khối u:    1. Không                 2. Có 
Q10: Loại hóa chất sử dụng: ................................................................................................ 
Q11: Đường dùng hóa chất .................................................................................................. 
 
 
 
 

82 
 
Phần 3. Đánh giá mức độ mất ngủ 
Với mỗi câu hỏi sau đây, ông/bà vui lòng khoanh tròn vào câu trả lời đúng với câu trả lời 
của mình nhất.  
Xin hãy đánh giá mức độ trầm trọng của chứng mất ngủ của ông/bà trong 2 tuần qua  
Triệu chứng mất ngủ 
Không 
Nhẹ 
Vừa phải 
Nặng 
Rất nặng 
1. Khó khăn để chìm vào giấc ngủ 
 
 
 
 
 
2. Khó khăn trong việc duy trì giấc ngủ 
 
 
 
 
 
3. Tỉnh giấc quá sớm 
 
 
 
 
 
4. Ông bà cảm thấy hài lòng hoặc không hài lòng với tình trạng giấc ngủ hiện nay như thế 
nào?  
Rất hài lòng 
Hài lòng 
Khá hài lòng 
Không hài lòng 
Rất không hài lòng 
0 
1 
2 
3 
4 
5. Tình trạng giấc ngủ của bạn ảnh hưởng đến chất lượng cuộc sống như thế nào?  
Không ảnh hưởng 
Một chút 
Hơi ảnh hưởng 
Nhiều 
Ảnh hướng rất 
nhiều 
0 
1 
2 
3 
4 
6. Ông bà lo lắng như thế nào về tình trạng rất ngủ của mình?  
Không lo lắng gì 
Một chút 
Hơi lo lắng 
Nhiều 
Rất lo lắng 
0 
1 
2 
3 
4 
7. Ông bà có cho rằng hiện nay tình trạng giấc ngủ của mình ảnh hưởng tới các hoạt động 
thường ngày không (ví dụ: gây mệt mỏi, ảnh hướng tới tâm trạng, khả năng làm việc, mức 
độ tập trung, trí nhớ…) 
Không ảnh hương 
Một chút 
Hơi lo lắng 
Nhiều 
Rất lo lắng 
0 
1 
2 
3 
4 
Tổng điểm (câu hỏi 1 + 2 + 3 + 4 + 5 +6 + 7) = _______  

83 
 
 
Phần 5. Đánh giá mức độ lo lắng và phiền muộn 
Hospital Anxiety and Depression Scale (HADS) 
Chọn câu trả lời đúng nhất cho tâm trạng của ông/bà trong tuần vừa qua. 
Vui lòng trả lời với ý đầu tiên mà ông bà cho là đúng nhất. 
Phần 1. Lo lắng 
No 
Câu hỏi 
Lựa chọn 
Điểm 
1 
Tôi cảm thấy căng thẳng và “tổn thương” 
a) Thường xuyên 
b) Nhiều lần 
c) Thỉnh thoảng 
d) Không hề 
 
2 
Tôi cảm thấy sợ hãi như sắp có chuyện 
chẳng lành sắp xảy ra 
 
a) Chắc chắn 
b) Nó sẽ xảy ra nhưng không chắc 
c) Nó không làm tôi lo lắng 
d) Không hề 
 
 
3 
Tôi cảm thấy lo lắng 
a) Thường xuyên 
b) Nhiều lần 
c) Thỉnh thoảng 
d) Không hề 
 
4 
Tôi có thể ngồi nghỉ và cảm thấy thư giãn 
a) Chắc chắn 
b) Thường xuyên 
c) Không thường xuyên 
d) Không hề 
 
 
5 
Tôi cảm thấy nỗi lo sợ cồn cào trong 
bụng  
 
a) Không hề 
b) Thỉnh thoảng 
c) Khá thường xuyên 
d) Rất thường xuyên 
 
6 
Tôi cảm thấy  mệt mỏi vì phải cố gắng 
bước tiếp: 
a) Thật sự rất nhiều 
b) Khá nhiều 
c) Không nhiều lắm 
d) Không hề 
 
7 
Tôi bỗng dưng thấy sợ hãi 
a) Thật sự rất nhiều 
b) Khá nhiều 
c) Không nhiều lắm 
d) Không hề 
 
. 
Tổng điểm lo lắng 
 
 

84 
 
Phần 1. Phiền muộn 
No 
Câu hỏi 
Lựa chọn 
Điểm 
1 
Tôi vẫn có thể tận hưởng những 
thứ mình thích: 
a) Rất nhiều 
b) Không nhiều 
c) Một chút 
d) Rất khó khăn 
 
2 
Tôi có cười và nhìn vào mặt tích 
cực 
a) Vẫn thường như tôi làm 
b) Không nhiều 
c) Không hề nhiều 
d) Không hề 
 
3 
Tôi cảm thấy hài lòng 
a) Không hề 
b) Không thường xuyên 
c) Thỉnh thoảng 
d) Phần lớn thời gian 
 
4 
Tôi cảm thấy tôi đang chậm lại 
a) Luôn luôn 
b) Rất thường xuyên 
c) Thỉnh thoảng 
d) Không hề 
 
5 
Tôi không quan tâm đến ngoại 
hình của mình 
a) Chắc chắn 
b) Tôi không quan tâm nhiều như lẽ ra phải 
quan tâm 
c) Tôi cũng quan tâm một chút 
d) Tôi vẫn luôn quan tâm đến ngoại hình 
 
6 
Tôi tìm kiếm nguồn vui 
a) Vẫn như tôi thường làm 
b) Ít hơn bình thường một chút 
c) Ít hơn rất nhiều 
d) Rất khó khắn 
 
7 
Tôi có thể thưởng thức một cuốn 
sách hay, một chương trình phát 
thanh hoặc chương trình TV hay 
a) Thường xuyên 
b) Thỉnh thoảng 
c) Không thường xuyên 
d) Rất hiếm khi 
 
. 
Tổng điểm trầm cảm 
 
 
 
 
 
 
 
 

85 
 
Phần 6. Đánh giá chất lượng cuộc sống 
Đánh giá chất lượng cuộc sống của bệnh nhân đang điều trị hóa chất 
Vui lòng lựa chọn đáp án phản ánh đúng nhất câu trả lời của bạn trong 7 ngày qua  
Code Câu hỏi 
Không 
hề 
Một 
chút 
Thỉnh 
thoảng 
Hơi 
thỉnh 
thoảng 
Rất 
nhiều 
GE1 
Tôi thấy buồn 
0 
1 
2 
3 
4 
GE2 
Tôi hài lòng với cách mà tôi đang thích nghi với 
bệnh tật của mình 
0 
1 
2 
3 
4 
GE3 
Tôi dần mấy hi vọng trong việc chống chọi lại bệnh 
tật của mình. 
0 
1 
2 
3 
4 
GE4 
Tôi thấy hồi hợp 
0 
1 
2 
3 
4 
GE5 
Tô lo lắng về cái chết 
0 
1 
2 
3 
4 
GE6 
Tôi lo lắng rằng tình trạng của tôi sẽ trầm trọng thêm 
0 
1 
2 
3 
4 
 
 
 
 
 
 
 
GF1 
Tôi có khả năng làm việc (kể cả việc nhà) 
0 
1 
2 
3 
4 
GF2 
Công việc của tôi (kể cả việc ở nhà) đem lại sự hài 
lòng, vui thích 
0 
1 
2 
3 
4 
GF3 
Tôi có thể vui sống 
0 
1 
2 
3 
4 
GF4 
Tôi đã chấp nhận bệnh tật của mình 
0 
1 
2 
3 
4 
GF5 
Tôi ngủ tốt 
0 
1 
2 
3 
4 
GF6 
Hiện tại tôi vui thích những gì tôi thường làm để giải 
trí 
0 
1 
2 
3 
4 
GF7 
Tôi hài lòng với chất lượng cuộc sống hiện tại của tôi 
0 
1 
2 
3 
4 
 
 
 
 
 
 
 
GP1 
Tôi cảm thấy thiếu năng lượng sống 
0 
1 
2 
3 
4 
GP2 
Tôi bị buồn nôn 
0 
1 
2 
3 
4 
GP3 
Vì tình trạng thân thể của mình, tôi khó đáp ứng các 
nhu cầu của gia đình của tôi 
0 
1 
2 
3 
4 
GP4 
Tôi bị đau 
0 
1 
2 
3 
4 
GP5 
Các phản ứng phụ của việc điều trị làm tôi bị khó chịu 
0 
1 
2 
3 
4 
GP6 
Tôi thấy ốm yếu 
0 
1 
2 
3 
4 
GP7 
Tôi buộc phải nằm nghỉ trên giường 
0 
1 
2 
3 
4 
 
 
 
 
 
 
 
GS1 
Tôi thấy gần gũi với bạn bè mình 
0 
1 
2 
3 
4 
GS2 
Tôi nhận được sự hỗ trợ tinh thần từ gia đình 
0 
1 
2 
3 
4 
GS3 
Tôi được bạn bè hỗ trợ 
0 
1 
2 
3 
4 
GS4 
Gia đình tôi chấp nhận bệnh tật của tôi 
0 
1 
2 
3 
4 
GS5 
Tôi cảm thấy hài lòng với những giao tiếp trong gia 
đình về bệnh của tôi 
0 
1 
2 
3 
4 
GS6 
Tôi rất gần gũi với bạn đời của mình (hoặc người 
chăm sóc chính)  
0 
1 
2 
3 
4 
Q1 
Bất kể mức độ hoạt động tình dục hiện nay của quý vị như thế nào 
Xin vui lòng trả lời câu hỏi dưới đây về hoạt động tình 
dục của ông bà. Nếu ông bà không muốn trả lời vui 
lòng đánh dấu X vào ô bên cạnh . 
 
 
 
 
 
GS7 
Tôi hài lòng với đời sống tình dục của mình 
0 
1 
2 
3 
4 

86 
 
Part 6.  Đánh giá mức độ của cụm triệu chứng gồm mất ngủ, lo âu, phiền muộn 
 
Với mỗi triệu chứng dưới đây, ông/bà vui lòng khoanh tròn vào chữ số mô tả đứng nhất mức độ 
của triệu chứng mà ông bà cảm nhận được trong tháng qua.  
 
Mất ngủ 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Không 
 
 
 
 
 
 
 
 
 
Trầm 
trọng 
nhất 
  
 
 
Phiền muộn 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Không 
 
 
 
 
 
 
 
 
 
Trầm 
trọng 
nhất 
 
 
Lo âu 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Không 
 
 
 
 
 
 
 
 
 
Trầm 
trọng 
nhất 

87 
 
 
Phần 7. Nhật ký giấc ngủ 
Hướng dẫn:  Vui lòng điền vào nhật ký giấc ngủ hàng ngày. Nếu có thể, ông bà vui lòng điền vào nhật ký giấc ngủ trong vòng 1 tiếng sau khi ngủ dậy vào sáng 
hôm sau. Nếu quên, ông bà có thể điền vào thời điểm khác trong ngày nhưng nếu ông bà không nhớ rõ thì có thể bỏ trống. Nếu giấc ngủ của ông bà bị ảnh hưởng 
bởi một vài lí do (đi du lịch, nhập viện…) vui lòng ghi rõ vào nhật ký. Vui lòng đọc các hướng dẫn tiếp theo để biết cách điền vào nhật ký giấc ngủ.  
Ngày: Vui lòng ghi ngày mà ông bà điền nhật ký giấc ngủ  
1. Giờ lên giường đi ngủ? Ghi thời gian ông/bà lên giường để đi ngủ.. Lưu ý đây là thời điểm ông bà lên giường để chuẩn bị đi ngủ chứ không phải là thời gian 
bắt đầu ngủ 
2. Ông bà bắt đầu ngủ khi nào? Ghi thời gian mà ông bà bắt đầu nhắm mắt để cố gắng chìm vào giấc ngủ.  
3. Mất bao lâu ông bà mới ngủ được? Tính từ thời điểm ông bà bắt đầu nhắm mắt để cố gắng chìm vào giấc ngủ, phải mất bao lâu ông bà mới ngủ được.  
4. Ông/bà thức giấc giữa đêm mấy lần? Ghi số lần ông bà thức dậy lúc đang ngủ bắt đầu từ lúc cố gắng ngủ cho đến lúc thức dậy hoàn toàn. 
5. Tổng thời gian tỉnh giấc giữa đêm? Tổng thời gian thức giấc giữa đêm của ông bà hôm qua là bao lâu? Ví dụ: trong lúc ngủ ông bà tỉnh giấc 3 lần, lần thứ nhất 
tỉnh mất 20 phút mới ngủ lại được, lần thứ 2 tỉnh mất 35 phút, lần thứ 3 tỉnh giấc mất 15 phút mới ngủ lại được, vậy tổng cộng trong khi ngủ đêm qua ông bà tỉnh 
giấc 20+35+15 = 70 phút..  
6. Mấy giờ ông bà ngủ dậy? Ghi thời gian ông bà tỉnh giấc vào sáng hôm sau. 
7. Mấy giờ thì ông bà ra khỏi giường? Ghi thời gian ông bà ra khỏi giường vào sáng hôm sau. Thời gian này có thể khác với thời gian ông bà ngủ dậy. Ví dụ ông 
bà ngủ dậy lúc 7h nhưng vẫn nằm trên giường (không ngủ) cho đến 7h30 mới ra khỏi giường. Thì ghi 7h vào câu số 6 và 7.30 vào câu số 7 
8. Ghi chú. Nếu giấc ngủ của ông bà bị ảnh hưởng bởi một vài lí do (đi du lịch, nhập viện…) vui lòng ghi rõ vào nhật ký. 
 
 

88 
 
NHẬT KÝ GIẤC NGỦ 
Tên người bệnh: 
………………………………………………………………Tuổi: 
…………………….Bệnh viện:…………………. 
Mã số: ………………………………………………………………………………………………………………………………………….. 
Ngày 
Ngày thứ 1 
Ngày thứ 2 
Ngày thứ 3 
Ngày thứ 4 
Ngày thứ 5 
Ngày thứ 6 
Ngày thứ 7 
 
 
1. Giờ lên giường đi 
ngủ 
 
 
 
 
 
 
 
2. Mấy giờ ông bà bắt 
đầu chìm vào giấc ngủ 
 
 
 
 
 
 
 
3. Mất bao lâu ông bà 
mới ngủ được 
 
 
 
 
 
 
 
4. Trong khi ngủ ông bà 
tỉnh giấc mấy lần 
 
 
 
 
 
 
 
5. Tổng thời gian tỉnh 
giấc của ông bà 
 
 
 
 
 
 
 
6. Mấy giờ ông bà dậy 
hẳn 
 
 
 
 
 
 
 
7. Mấy giờ ông bà ra 
khỏi giường 
 
 
 
 
 
 
 
8. Ghi chú  
 
 
 
 
 
 
 
 
 
 
 
 

89 
 
Phần 8. Phiếu theo dõi bấm huyệt 
Tên người bệnh: 
…………………………………………………………Tuổi: ……………Bệnh viện:…………………. 
Mã số: ……………………………………………………………………………………………………………………………… 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
 
11 
 
12 
 
13 
 
14 
 
Số huyệt 
ông bà bấm 
hôm nay 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Thời gian 
bấm huyệt 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Nếu hôm 
nay ông bà 
không bấm 
huyệt, làm 
ơn ghi lí do 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Các khó 
chịu gặp 
phải khi 
bấm huyệt 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ông bà có dùng thêm thuốc/thực phẩm chức năng gì để điều trị mất ngủ, lo âu, phiền muộn không: 
 
Vui lòng ghi rõ tên thuốc: (1)…………………………………………. 
 Liều dùng:……………………………………………… 
                                          (2)…………………………………………. 
 Liều dùng:……………………………………………… 
 

90 
 
Phần 8. Phiếu theo dõi bấm huyệt 
Tên người bệnh: 
…………………………………………………………Tuổi: ……………Bệnh viện:…………………. 
Mã số: ……………………………………………………………………………………………………………………………… 
 
15 
 
16 
 
17 
 
18 
 
19 
 
20 
 
21 
 
22 
 
23 
 
24 
 
25 
 
26 
 
27 
 
28 
 
Số huyệt 
ông bà bấm 
hôm nay 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Thời gian 
bấm huyệt 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Nếu hôm 
nay ông bà 
không bấm 
huyệt, làm 
ơn ghi lí do 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Các khó 
chịu gặp 
phải khi 
bấm huyệt 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ông bà có dùng thêm thuốc/thực phẩm chức năng gì để điều trị mất ngủ, lo âu, phiền muộn không: 
 
Vui lòng ghi rõ tên thuốc: (1)…………………………………………. 
 Liều dùng:……………………………………………… 
                                          (2)…………………………………………. 
 Liều dùng:………………………………………………

91 
 
Appendix 2.  The intervention rating profile-15 
The purpose of this questionnaire is to obtain information that help to refine the study protocol for 
future main study. Please circle the number which best describes your agreement or disagreement 
with each statement.  
 
Strongly 
disagree 
Disagree 
Slightly 
disagree 
Slightly 
agree 
Agree 
Strongly 
agree 
1. This was an acceptable 
intervention for me to reduce 
the symptom cluster burden 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
2. Most of the patient with 
similar symptoms would find 
this intervention appropriate 
for their needs. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
3. This intervention proved 
effective in reducing the 
symptom cluster burden 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
4. I would suggest this 
intervention to other patients 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
5. My symptoms burden was 
severe enough to warrant use 
of this intervention 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
6. Most patients would find this 
intervention suitable for their 
needs 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
7. I would be willing to use this 
treatment  
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
8. This intervention did not result 
in negative side-effect for me 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
9. This treatment would be 
appropriate for a variety of 
cancer patients. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
10. This intervention was 
consistent with those I have 
used 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
11. The intervention was a fair 
way to handle symptoms 
burden 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
12. This intervention is reasonable 
for reducing symptom burden 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
13. I like the procedures used in 
this intervention. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
14. This intervention was a good 
way to handle symptoms 
burden 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
15. Overall, this intervention 
would be beneficial for me 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
 
 

92 
 
Phụ lục 4.  Đánh giá phương pháp bấm huyệt để giảm triệu chứng 
Mục đích của bộ câu hỏi này nhằm giúp chúng tôi cải tiến quy trình của phương pháp điều trị bằng 
bấm huyệt cho nghiên cứu lớn hơn. Vui lòng khoang tròn vào số phản ánh đúng nhất mức độ đồng ý 
hoặc không đồng ý của ông bà với mỗi câu dưới đây..  
 
Rất 
không 
đồng ý 
Không 
đồng ý 
Không 
đồng ý 
một chút 
Đồng ý 
một chút 
Đồng ý 
Rất đồng 
ý 
1. Tôi thấy phương pháp này có 
thể dùng để chữa các triệu 
chứng của tôi  
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
2. Phần lớn các bệnh nhân có 3 
triệu chứng này sẽ thấy 
phương pháp này là hợp lý. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
3. Phương pháp này chứng minh 
được tác dụng giảm các triệu 
chứng 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
4. Tôi sẽ giới thiệu phương pháp 
này tới người khác 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
5. Các triệu chứng của tôi ở mức 
độ đủ nặng để áp dụng 
phương pháp này 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
6. Phần lớn các bệnh nhân sẽ 
thấy phương pháp này đáp 
ứng dc nhu cầu của họ 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
7. Tôi rất sẵn sàng áp dụng 
phương pháp điều trị này  
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
8. Bấm huyệt không gây bất kỳ 
tác dụng phụ nào cho tôi 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
9. Phương pháp này là thích hợp 
cho người bệnh ung thư. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
10. Phương pháp này không đi 
ngược lại các phương pháp tôi 
đã áp dụng 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
11. The intervention was a fair 
way to handle symptoms 
burden 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
12. Phương pháp này là rất hợp lý 
để điều trị các triệu chứng 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
13. Tôi thích quy trình của 
phương pháp điều trị này 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
14. Phương pháp rất tốt để giúp 
tôi giảm khó chịu từ các triệu 
chứng  
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
15. Nhìn chung, phương pháp này 
là hữu ích đối với tôi 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
 
 

93 
 
Appendix 3. Protocol for the self-acupressure training section for participants 
 
1. Purpose of the training section:  
To train participants how to practice self-acupressure to manage insomnia, depression, 
and anxiety at home. 
2. Objective of the training section 
After receiving training section, participants are: 
- Able to locate the acupoints 
- Able to apply right pressure techniques in each acupoint 
- Able to understand the dose of the treatment. 
3. Location: In the consultation room of hospital. 
4. Duration: 30 minutes. 
5. Number of participants per section: 3 to 5 participants 
6. Instructor: Trained interventionist. 
7. Training materials 
For TSA group: Handout of Self-acupressure protocol + Acupressure Skill check A 
For SSA group: Handout of Sham acupressure protocol + Acupressure Skill check B 
7. Detail of training section 
 
Step 
Content 
Interventionist does 
Participants do 
1 
Introduce of the training 
section: Purpose and 
Objective   
Lecture 
 
2 
Introduce method of how to 
locate a acupoint and pressure 
techniques using the 
treatment protocol handout 
Demonstration 
 
3 
Practice of the method and 
skill to locate the selected 
acupoint and pressure 
techniques. 
Supervise participants to 
practice. 
Asking participants to locate 
and stimulate acupoints. 
Return 
demonstration and 
practice 
4 
Revision and correct 
participant if they fail to 
identify or stimulate 
acupoints 
Demonstration 
Return 
demonstration and 
practice 
5 
Checks the patient’s mastery 
of self-acupressure technique 
Using Acupressure Skill 
Check form to checks the 
participant’s mastery. 
Return 
demonstration 
6 
Summarize the training 
section and provide the 
treatment protocol to 
participants. 
Lecture 
 

94 
 
Appendix 4. Interventionist Skill Check of Acupressure and Sham Acupressure 
 
Interventionist Skill Check of Acupressure 
Name of Interventionist: ...............................................................................................  
Date: ..............................................................................................................................  
Skills 
Score (*) 
Location of Acupoint 
1. Acupoint AP1 
 
2. Acupoint AP2 
 
3. Acupoint AP3 
 
4. Acupoint AP4 
 
5. Acupoint AP5 
 
6. Acupoint AP6 
 
General Stimulation techniques 
7. Applying pressure time 
 
8. Acupoint confirmation (identification of sore, numb, heavy, 
distended/warm) 
 
Specific stimulation techniques 
 
9. Acupoint AP1: Specific techniques on applying pressure 
 
10. Acupoint AP2: Specific techniques on applying pressure 
 
11. Others Acupoints:  Specific techniques on applying pressure 
 
Total 
 
*Scoring instruction 
0 = Incorrect, 1 = Correct 
 
 
 
 
 
 
 

95 
 
Interventionist Skill Check of Sham Acupressure 
 
Name of Interventionist: ...............................................................................................  
Date: ..............................................................................................................................  
Skills 
Score (*) 
Location of Acupoint 
1. Acupoint SA1 
 
2. Acupoint SA2 
 
3. Acupoint SA3 
 
4. Acupoint SA4 
 
5. Acupoint SA5 
 
6. Acupoint SA6 
 
General Stimulation techniques 
7. Applying pressure time 
 
Specific stimulation techniques 
 
8. Acupoint SA1: Specific techniques on applying pressure 
 
9. Acupoint SA2: Specific techniques on applying pressure 
 
10. Others Sham Acupoints:  Specific techniques on applying 
pressure 
 
Total 
 
*Scoring instruction 
0 = Incorrect, 1 = Correct 
 
 

96 
 
Bảng kiểm kỹ thuật bấm huyệt của điều dưỡng 
Tên điều dưỡng: 
 
Ngày:  
Kỹ năng 
Điểm (*) 
Xác định vị trí huyệt 
1. Huyệt AP1 
 
2. Huyệt AP2 
 
3. Huyệt AP3 
 
4. Huyệt AP4 
 
5. Huyệt AP5 
 
6. Huyệt AP6 
 
Kỹ thuật bấm huyệt chung 
7. Thời gian bấm 
 
8. Đắc khí 
 
Kỹ thuật bấm huyệt cụ thể 
 
9. Huyệt AP1: thực hiện đúng kỹ thuật bấm huyệt 
 
10. Huyệt AP2: thực hiện đúng kỹ thuật bấm huyệt 
 
11. Các huyệt khác:  thực hiện đúng kỹ thuật bấm huyệt 
 
Tổng điểm 
 
*Hướng dẫn chấm điểm 
0 = Sai, 1 = Đúng 
 
 
 
 
 
 
 

97 
 
Bảng kiểm kỹ thuật bấm huyệt giả của điều dưỡng 
 
Tên điều dưỡng: 
 
Ngày: 
Kỹ năng 
Điểm (*) 
Xác định vị trí huyệt 
1. Huyệt SA1 
 
2. Huyệt SA2 
 
3. Huyệt SA3 
 
4. Huyệt SA4 
 
5. Huyệt SA5 
 
6. Huyệt SA6 
 
Kỹ thuật bấm huyệt chung 
7. Thời gian bấm huyệt 
 
Kỹ thuật bấm huyệt cụ thể 
 
8. Huyệt SA1: thực hiện đúng kỹ thuật bấm huyệt 
 
9. Huyệt SA2: thực hiện đúng kỹ thuật bấm huyệt 
 
10. Các giả huyệt khác:  thực hiện đúng kỹ thuật bấm huyệt 
 
Tổng điểm 
 
*Hướng dẫn chấm điểm 
0 = Sai, 1 = Đúng 
 
 

98 
 
Appendix 5. Acupressure Skill Check Forms for participants* 
Noted: Acupressure Skill Check Form (A) is for participants in the True self-
acupressure group and Acupressure Skill Check Form (B) is for participants in the 
Sham Self-Acupressure group 
Acupressure Skill Check Form (A)  
Name of participant: .....................................................................................................  
Hospital: ........................................................................................................................  
Code: .............................................................................................................................  
Date: ..............................................................................................................................  
Skills 
Score (*) 
Location of Acupoint 
1. Acupoint AP1 
 
2. Acupoint AP2 
 
3. Acupoint AP3 
 
4. Acupoint AP4 
 
5. Acupoint AP5 
 
6. Acupoint AP6 
 
General Stimulation techniques 
7. Applying pressure time 
 
8. Acupoint confirmation (identification of sore, numb, heavy, 
distended/warm) 
 
Specific stimulation techniques 
 
9. Acupoint AP1: Specific techniques on applying pressure 
 
10. Acupoint AP2: Specific techniques on applying pressure 
 
11. Others Acupoints:  Specific techniques on applying pressure 
 
Total 
 
*Scoring instruction 
0 = Incorrect, 1 = Correct 
 
 
 

99 
 
Acupressure Skill Check Form (B) 
 
Name of participant: .....................................................................................................  
Hospital: ........................................................................................................................  
Code: .............................................................................................................................  
Date: ..............................................................................................................................  
Skills 
Score (*) 
Location of Acupoint 
1. Acupoint SA1 
 
2. Acupoint SA2 
 
3. Acupoint SA3 
 
4. Acupoint SA4 
 
5. Acupoint SA5 
 
6. Acupoint SA6 
 
General Stimulation techniques 
7. Applying pressure time 
 
Specific stimulation techniques 
 
8. Acupoint SA1: Specific techniques on applying pressure 
 
9. Acupoint SA2: Specific techniques on applying pressure 
 
10. Others Acupoints:  Specific techniques on applying pressure 
 
Total 
 
*Scoring instruction 
0 = Incorrect, 1 = Correct 
 
 
 
 
 
 
 

100 
 
Bảng kiểm kỹ thuật bấm huyệt của người bệnh* 
Ghi chú: Bảng kiễm kỹ thuật bấm huyệt (A)  dành cho người bệnh trong nhóm bấm 
huyệt thật. Bảng kiểm kỹ thuật (B) dành cho người bệnh trong nhóm bấm huyệt giả  
Bảng kiểm kỹ thuật bấm huyệt của người bệnh (A) 
Tên người bệnh: 
 
Bệnh viện: 
 
Code:  
Ngày:  
Kỹ năng 
Điểm (*) 
Xác định vị trí huyệt 
1. Huyệt AP1 
 
2. Huyệt AP2 
 
3. Huyệt AP3 
 
4. Huyệt AP4 
 
5. Huyệt AP5 
 
6. Huyệt AP6 
 
Kỹ thuật bấm huyệt chung 
7. Thời gian bấm 
 
8. Đắc khí 
 
Kỹ thuật bấm huyệt cụ thể 
 
9. Huyệt AP1: thực hiện đúng kỹ thuật bấm huyệt 
 
10. Huyệt AP2: thực hiện đúng kỹ thuật bấm huyệt 
 
11. Các huyệt khác:  thực hiện đúng kỹ thuật bấm huyệt 
 
Tổng điểm 
 
*Hướng dẫn chấm điểm 
0 = Sai, 1 = Đúng 
 
 
 

101 
 
Bảng kiểm kỹ thuật bấm huyệt của người bệnh (B) 
 
Tên người bệnh: 
 
Bệnh viện: 
 
Code:  
Ngày:  
Kỹ năng 
Điểm (*) 
Xác định vị trí huyệt 
1. Huyệt SA1 
 
2. Huyệt SA2 
 
3. Huyệt SA3 
 
4. Huyệt SA4 
 
5. Huyệt SA5 
 
6. Huyệt SA6 
 
Kỹ thuật bấm huyệt chung 
7. Thời gian bấm huyệt 
 
Kỹ thuật bấm huyệt cụ thể 
 
8. Huyệt SA1: thực hiện đúng kỹ thuật bấm huyệt 
 
9. Huyệt SA2: thực hiện đúng kỹ thuật bấm huyệt 
 
10. Các giả huyệt khác:  thực hiện đúng kỹ thuật bấm huyệt 
 
Tổng điểm 
 
*Hướng dẫn chấm điểm 
0 = Sai, 1 = Đúng 
 
 
 
 
 
 
 
 
 
 
 

102 
 
Appendix 6. Acupresssure Protocol Validation Form 
Acupressure Protocol Validation Form 
Instruction:  Please circle the number which best describes your agreement level with each of the items in the form. If you have comments 
or suggestion for any item please write down in the  “comments” column.  Please provide references if your comments or suggestions come 
from relevant studies. 
1. True self-acupressure protocol 
Content 
Appropriateness of the content 
Comments 
Very 
appropriate 
Appropriate 
Inappropriate 
Very 
Inappropriate  
Selection of the acupoint 
Baihui (GV20) 
4 
3 
2 
1 
 
Yingtang (EN-HN3) 
4 
3 
2 
1 
 
Fengchi (GB20) 
4 
3 
2 
1 
 
Hegu (LI4) 
4 
3 
2 
1 
 
Shenmen (HT7) 
4 
3 
2 
1 
 
Taichong (LR3) 
4 
3 
2 
1 
 
Pressing technique 
Baihui: using four finger pads, gently tap the area of this acupoint on the scalp 
4 
3 
2 
1 
 
Fengchi: using two thumbs, press in the acupoint bilaterally while the other four 
fingers should hold the back of the head naturally 
4 
3 
2 
1 
 
Other acupoints: using thumb pad, firmly massage the surrounding area of this 
acupoint 
4 
3 
2 
1 
 
Duration of each session: 24 minute 
(3 minute for each acupoint; for Fengchi and Taichong, participants will 
press both sides of the body at the same time; for Hegu and Shenmen, 
participant will press the right side, followed by the left side) 
4 
3 
2 
1 
 
Duration of whole treatment: four weeks (28 days) 
4 
3 
2 
1 
 
Frequency: Once a day 
4 
3 
2 
1 
 
Time for practice self-acupressure: Before bedtime  
4 
3 
2 
1 
 

103 
 
2. Sham  self-acupressure protocol 
 
Content 
Appropriateness of the content 
Comments 
Very 
appropriate 
Appropriate 
Inappropriate 
Very 
Inappropriate  
Selection of the sham acupoint 
SA 1: 3cm away from Baihui 
4 
3 
2 
1 
 
SA 2: 3 cm away from Ying Tang 
4 
3 
2 
1 
 
SA 3: Mastoid bone 
4 
3 
2 
1 
 
SA 4: Head of ulnar styloid 
4 
3 
2 
1 
 
SA 5: Base of metacarpal bone of the index finger 
4 
3 
2 
1 
 
SA 6: 3 cm away from Taichong 
4 
3 
2 
1 
 
Pressing technique 
SA 1: using four finger pads, gently tap the area of this sham acupoint on the 
scalp 
4 
3 
2 
1 
 
SA 3: using two thumbs, press in the acupoint bilaterally while the other four 
fingers should hold the back of the head naturally 
4 
3 
2 
1 
 
Other acupoints: using thumb pad, firmly massage the surrounding area of this 
sham acupoint 
4 
3 
2 
1 
 
Duration of each session: 24 minute 
(3 minutes for each acupoint; for SA 3 and SA 6, participants will press 
both sides of the body at the same time; for SA 5 and SA 4, participants 
will press the right side, followed by the left side) 
4 
3 
2 
1 
 
Duration of whole treatment: four weeks (28 days) 
4 
3 
2 
1 
 
Frequency: Once a day 
4 
3 
2 
1 
 
Time for practice self-acupressure: Before bedtime  
4 
3 
2 
1 
 

104