The Dreamcatchers Programme - A Nurse-led Multicomponent Interventional Protocol to Improve Sleep Quality in Paediatric Oncology Patients: A Pilot Randomized Controlled Trial
Phase: NA
Conditions: Pediatrics Cancer
Sponsor: Chinese University of Hong Kong

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The Dreamcatchers Programme 
A Nurse-led Multicomponent Interventional Protocol to Improve Sleep 
Quality in Paediatric Oncology Patients:  
A Pilot Randomized Controlled Trial 
Research Protocol 
Version 3.2, 22nd July 2025 
 
 
 
 
Principal Investigator: Ms. Mak Shuk Yan 
Ward Manager (Paediatrics and Adolescent Medicine), Hong Kong Children’s Hospital 
 
Co-Investigators:  
Prof. Li Ho Cheung William  
Professor, The Nethersole School of Nursing, The Chinese University of Hong Kong 
Prof. Cheung Tan Ankie 
Assistant Professor, The Nethersole School of Nursing, The Chinese University of Hong Kong 
 
 

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Table of Contents 
 
 
Content 
Page 
1. Introduction 
2 
2. Literature Review 
2.1 Theoretical Framework 
2.2 Literature Gaps 
3 
4 
5 
3. Service Gaps 
5 
4. Study Objectives 
6 
5. Hypothesis 
7 
6. Outcome Measures 
8 
7. Study Design 
7.1 Randomization and Allocation 
7.2 Blinding Procedures 
7.3 Contamination Prevention 
7.4 Duration 
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8. Sampling Method and Sample Size Planning 
8.1 Eligibility Criteria 
8.2 Sample Size Planning 
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9. Description of Evidence-based Protocol 
9.1 Sleep Hygiene Education 
9.2 Progressive Muscle Relaxation (PMR) 
9.3 Breathing Exercises 
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10. Data Collection Methods and Procedures 
10.1 Participant Recruitment 
10.2 Baseline Assessment (T0) 
10.3 Post-intervention Assessment (T1) 
10.4 Three-month Follow-up (T2) 
10.5 Data Integrity and Confidentiality 
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11. Instruments 
11.1 Chinese Version of the PSQI 
11.2 Chinese Version of the PedsQL Cancer Module 3.0 
11.3 Sleep Diary 
11.4 Satisfaction Survey 
11.5 Semi-structured Interview  
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12. Data Analysis 
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13. Parental Consent and Children’s Assent 
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14. Ethical Approval and Considerations 
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15. Significance of the Study 
20 
References 
22 
Appendix I – Summary of Literature 
28 
Appendix II – Intervention and Data Collection Methods and 
Procedures 
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The Dreamcatchers Programme – A Nurse-led Multicomponent Interventional 
Protocol to Improve Sleep Quality in Paediatric Oncology Patients: A Pilot 
Randomized Control Trial 
Version 2, 16th June 2025 
1. Introduction 
Sleep plays a crucial role in a child’s development, contributing to cognitive functioning, 
emotional stability, recovery and overall wellness (Baddam & Nasser, 2021; Blackwell 
et al., 2020). Prolonged and intensive treatments received by paediatric oncology 
patients can lead to sleep disturbances that many carers and healthcare professionals 
overlook as transient side effects (Daniel et al., 2019). Sleep disturbances can be 
presented as a cluster of symptoms including difficulty initiating or maintaining sleep, 
reduced sleep duration, or perceived poor sleep quality (Richards & Pao, 2014). Recent 
studies showed that prevalence rates of sleep disturbance in leukemia survivors range 
from 13% to 50% (Russell et al., 2020), and up to 80% in children with central nervous 
system tumours (Rosen & Brand, 2020). Furthermore, a recent Hong Kong study by 
Ho et al. (2022) revealed that around 45% of pediatric oncology survivors struggle with 
ongoing sleep, which highlights the relevance of this issue globally as well as in local 
areas. 
Sleep disturbances in this vulnerable population stem from factors such as pain and 
nausea from side effects of chemotherapies, and corticosteroids exacerbate these 
disturbances (Gedaly-Duff et al., 2006; Hinds et al., 2007; Lee et al., 2017). Not only 
would sleep disturbances cause immediate discomfort, but it would also significantly 
impact paediatric oncology patients’ treatment adherence, daily activities, social 
engagement and quality of life (Cheung et al., 2017; Matricciani et al., 2019).  
While pharmacological approach remains to be the go-to management for paediatric 
sleep disturbances, with about 60% of paediatric oncology patients being prescribed 
with sedatives (Walter et al., 2015), this approach carries extensive risks. Polypharmacy 
can lead dangerous drug interactions and development of drug dependency (Dhir et al., 
2024; Owens et al., 2010). In contrast, non-pharmacological options allow patients and 
caregivers to manage their sleeping problems without increasing medication burden 
(Rogers et al., 2019), and also encourage patients and families to take a more proactive 

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role in managing patients’ sleep health. 
The Dreamcatchers Programme was developed as a nurse-led initiative in response to 
the pressing need of improving sleep quality in pediatric oncology patients. The 
programme supports relaxation and offers sustainable strategies for better sleep by 
introducing sleep hygiene, progressive muscle relaxation (PMR) and breathing control 
exercises to patients and carers. Evidence-based intervention supplies nurses with 
techniques built on holistic care, bridging gaps in nursing knowledge and skills. 
This project proposal outlines a randomized controlled pilot study to evaluate the 
feasibility and preliminary effectiveness of the Dreamcatchers Programme, laying the 
foundation for a standardized sleep management protocol in pediatric oncology care. 
The following sections detail the literature base, service gaps, study design, and 
implementation strategies supporting this initiative.  
2. Literature Review 
A systematic review of non-pharmacological interventions for sleep in pediatric 
oncology was conducted from December 2023 to April 2024, with an extended search 
period through March 2025. The review analyzed the results of nine studies that 
implemented various strategies like music therapy, cognitive-behavioral interventions, 
physical activity and mindfulness (Hinds et al., 2007; Jacobs et al., 2016; Khoirunnisa 
et al., 2019; Liu et al., 2019; Rogers et al., 2019; Sriasih et al., 2019; Sulistyawati et al., 
2021; Tanriverdi et al., 2022; Zupanec et al., 2017). Databases such as MEDLINE 
(Ovid), EMBASE (Ovid), PsycINFO, CINAHL and Cochrane Library were used in this 
review and the articles searched for non-pharmacological solutions to sleep problems. 
These interventions align with Spielman’s behavioral model of insomnia, addressing 
the factors that contribute to, exacerbate, or maintain sleep disturbances (Spielman et 
al., 1987). 
The systematic review identified interventions that promote relaxation through 
physiological and psychological mechanisms and summarized in Appendix I. The 
interventions included in the 9 studies induce relaxation by reducing hyperactivity, 
muscle tension, and anxiety, which typically affect sleep in pediatric oncology patients. 
Practicing breathing exercises like diaphragmatic breathing can stimulate the 

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parasympathetic system, leading to a reduction in heart rate, cortisol level, and feelings 
of arousal which supports sleep at night (Chen et al., 2016; Murphy, 2019). Doing 
gentle routines while focusing on muscles helps ease tension in the body, lessen 
discomfort caused by treatment and encourage relaxation for better sleep (Khoirunnisa 
et al., 2019; Sulistyawati et al., 2021). Sleep hygiene education is a central part of 
cognitive-behavioral approaches and supports establishing good sleep routines and a 
suitable sleep environment, which minimizes factors that can disrupt sleep (Rogers et 
al., 2019; Sriasih et al., 2019; Zupanec et al., 2017). 
Mindfulness and education-based multicomponent approaches have been shown to 
reduce stress and help improve sleep quality (Liu et al., 2019; Sriasih et al., 2019). 
Zupanec et al. (2017) found that having a four-week relaxation and education program 
boosted sleep duration, underlining the efficacy of multicomponent approaches. 
Complementary therapies like massage showed subjective improvements in sleep and 
fatigue, yet quantitative outcomes were less robust (Jacobs et al., 2016). Physical 
activities including virtual reality-based exercises yielded mixed results, suggesting 
integration of physical activity with relaxation techniques would be more impactful 
(Tanriverdi et al., 2022). Nonetheless, the review demonstrated the feasibility of nurse-
led delivery and highlighted the need for well-outlined steps. 
2.1 Theoretical Framework 
Spielman’s model provides a framework for understanding how relaxation-based 
interventions address sleep disturbances by targeting predisposing, precipitating, and 
perpetuating factors (Spielman et al., 1987): Pediatric oncology patients are 
predisposed to insomnia due to baseline anxiety and stress from their diagnosis and 
treatments. Breathing and PMR exercises counter hyperarousal by engaging the 
parasympathetic nervous system, reducing cortisol levels and anxiety, enabling 
easier relaxation and sleep onset (Annisa et al., 2018; Chen et al., 2016). Regular 
practice mitigates cancer-related stress, addressing predisposing vulnerabilities 
(Sulistyawati et al., 2021).  
Treatment-related pain, nausea, and emotional distress from hospitalization are 
categorized as precipitating factors that can trigger insomnia. Breathing and PMR 
exercises alleviate physical discomfort by releasing muscle tension and diverting 

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attention from pain, reducing the impact of precipitating factors (Khoirunnisa et al., 
2019; Sulistyawati et al., 2021). These techniques are accessible and require minimal 
equipment, unlike music therapy, which may rely on trained professionals or 
resources (da Silva Santa et al., 2021; Ramanda et al., 2022). 
Frequent naps or irregular sleeping times can decrease sleep drive which perpetuates 
to further sleep disturbances. Promoting regular routines and a suitable sleeping 
environment through education with caregivers can change these patterns (Rogers et 
al., 2019; Zupanec et al., 2017). Moreover, breathing exercises calm children and 
help them get back to sleep in case of nighttime awakenings (Murphy, 2019). 
Breathing and PMR exercises offer distinct advantages over other interventions like 
music therapy or mindfulness. These techniques are simple, requiring no specialized 
equipment or extensive training, making them suitable for hospital or home settings 
(Chen et al., 2016). They can be adapted into playful activities (e.g. imagining 
squeezing lemons), engaging younger children who may struggle with mindfulness 
due to limited cognitive maturity (Burke, 2010; Burrows, 2022). Breathing and PMR 
exercises are cost-effective and scalable (da Silva Santa et al., 2021). They can 
alleviate physical discomforts to facilitate relaxation and enhance sleep as opposed 
to mindfulness that primarily targets mental and emotional dimensions (Sulistyawati 
et al., 2021). 
2.2 Literature Gaps 
Despite promising findings from the systematic review, standard procedures for 
managing sleep in children with cancer are found to be lacking in the published 
literature. Most of the measures taken were brief and there was no data available for 
long-term evaluation. The existing studies rarely review the sleep differences among 
children of various ages or the ways caregivers assist with sleep routines. 
Methodological limitations, including small sample sizes, reliance on self-report 
measures, and inconsistent reporting of intervention fidelity result in poor 
reproducibility. 
3. Service Gaps 
Sleep disturbances among paediatric oncology patients are often thought of as 

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temporary, instead of requiring more specific care (Daniel et al., 2019). Patients seldom 
report their sleep issues thus the problem is rarely being assessed. In current Hong 
Kong’s clinical practice, there are no standardized protocols for addressing sleep 
disturbances, and bundled care approaches are often hindered by intensive treatments 
in minimizing patients’ sleep disturbances. Zhou and Recklitis (2014) reported that 
nearly two-thirds of pediatric oncology patients did not get a routine check of their 
sleep-related issues during long-term follow-ups. This oversight results in a passive 
approach to addressing sleep complaints, only addressing them when they severely 
disrupt daily functioning. Consequently, cancer children experience sleep deprivation 
which can worsen their exhaustion, mood and performance. 
While standardized non-pharmacological techniques are lacking, most sleep problems 
in children with cancer are managed with drugs, with over half of these patients 
prescribed with sedatives (Walter et al., 2015). Nevertheless, children who take multiple 
drugs and are given sedatives may face increased risks such as of addiction, mental fog 
and potential negative interactions between drugs (Dhir et al., 2024; Owens et al., in 
2010), causing extra burden on caregivers, thus proving that new safe options are 
necessary. 
Hong Kong nurses in paediatric oncology lack special training in sleep assessments and 
behavioral interventions. The integration of sleep care into holistic nursing practice 
relies on the development of guidelines and institutional support. Although there is 
evidence for non-pharmacological interventions, they face challenges due to lack of 
proper training for staff and practical logistical issues in hospitals. 
4. Study Objectives 
The Dreamcatchers Programme aims to close the gap by using a well-structured and 
evidence-based method developed by nurses for Hong Kong paediatric oncology 
patients. The pilot study seeks to evaluate the feasibility and preliminary efficacy of a 
nurse-led, non-pharmacological intervention designed to improve sleep quality in 
pediatric oncology patients. Grounded in behavioral approaches and integrated into 
routine clinical practice, the programme combines sleep hygiene education, PMR, and 
breathing control techniques. The specific objectives of this pilot study are as follow: 

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1. Primary Objective: 
To improve sleep quality (perceived restfulness), sleep latency, habitual sleep 
efficnecy, sleep disturbances and duration in pediatric oncology patients aged 
6–12 years, as measured through Chinese version of the Pittsburgh Sleep 
Quality Index (PSQI). 
2. Secondary Objective: 
To enhance the overall quality of life of participating children by promoting 
better sleep patterns during active cancer treatment and assess through Chinese 
version of Pediatrics Quality of Life Inventory (PedsQL) 3.0 Cancer Module.  
3. Feasibility and Acceptability Objective: 
To assess the feasibility of the study, the recruitment, response, and retention 
rates will be documented. To assess the acceptability of the intervention by 
healthcare professionals and participants, a satisfaction survey and process 
evaluation will be conducted. The process evaluation is to assess whether the 
intervention is delivered as planned and to identify patients’ perspectives on the 
intervention’s strengths and limitations. The findings should help improve the 
effectiveness of the intervention and show if both healthcare workers and 
participants find the intervention usable and acceptable.  
These objectives reflect a commitment to advancing holistic, evidence-informed 
strategies within pediatric oncology settings, with the long-term aim of strengthening 
nurses and ensuring better outcomes for patients, turning sleep management into a 
regular care plan for pediatric oncology. 
5. Hypothesis 
The Dreamcatchers Programme pilot study hypothesizes that: 
1. Primary Hypothesis:  
The nurse-led multicomponent intervention will significantly improve sleep 
quality in pediatric oncology patients aged 6–12 compared to the waitlist control 
group, as measured by the Chinese PSQI, enhancing perceived restfulness, sleep 
latency, habitual sleep efficiency, sleep disturbances, and duration at T1 and T2. 

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2. Secondary Hypothesis:  
The intervention will enhance quality of life in patients undergoing active 
cancer treatment compared to the control group, as assessed by the Chinese 
PedsQL Cancer Module 3.0 at T1 and T2. 
3. Feasibility and Acceptability Hypothesis:  
The intervention will be feasible (measured by recruitment, response, and 
retention rates) and acceptable to participants and healthcare professionals 
(evaluated via satisfaction surveys and semi-structured interviews), supporting 
integration into routine clinical practice. 
6. Outcome Measures 
The primary outcome focuses on improvements in sleep quality among pediatric 
oncology patients aged 6–12 years, as measured by the Chinese version of the 
Pittsburgh Sleep Quality Index (PSQI). Specifically, the study aims to assess: 
 
Perceived restfulness: Subjective sense of feeling rested after sleep. 
 
Sleep latency: Time taken to fall asleep. 
 
Habitual sleep efficiency: Ratio of total sleep time to time spent in bed. 
 
Sleep disturbances: Frequency and severity of disruptions during sleep. 
 
Sleep duration: Total amount of sleep obtained per night. 
These components are captured through the PSQI global score, where a lower score 
indicates better sleep quality. 
The secondary outcome focuses on enhancing the overall quality of life of 
participating children during active cancer treatment, as measured by the Chinese 
version of the Pediatric Quality of Life Inventory (PedsQL) Cancer Module 3.0. 
This includes: 
 
Health-related quality of life: Assessed through subscales addressing pain, 
fatigue, cognitive problems, and other treatment-related symptoms.  
Higher PedsQL scores indicate better quality of life. 
Additionally, the study evaluates feasibility and acceptability as secondary 
outcomes to determine the intervention’s potential for integration into clinical 
practice: 

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 
Feasibility: Measured by recruitment rates, response rates, and retention rates 
throughout the study. 
 
Acceptability: Assessed through a custom-designed satisfaction survey (with 
Likert-scale and open-ended questions) and semi-structured interviews 
conducted with the intervention group at T1.  
These tools evaluate the clarity of educational materials, ease of performing 
exercises, perceived benefits, and overall satisfaction with the Dreamcatchers 
Programme. 
7. Study Design 
This study is structured as a pilot prospective and randomized controlled trial (RCT) 
with a 1:1 allocation to either the intervention group or waitlist control group. The 
intervention group will receive the Dreamcatchers Programme, including sleep hygiene 
education, PMR, and breathing control exercises, which will be delivered over 4 weeks 
with weekly in-person follow-ups. The waitlist control group will continue to receive 
routine hospital support and pediatric oncology health information (e.g., neutropenic 
diet tips) to maintain engagement without sleep-specific strategies. The trial will span 
4 weeks, followed by a 3-month follow-up to assess the sustainability of outcomes. 
7.1 Randomization and Allocation 
The study will arrange participants in intervention and waitlist control groups at a 
1:1 ratio through block randomization. A computer will be used to generate blocks 
for randomization to guarantee all the groups are of equal size and to minimize the 
risk of allocation bias. The randomization sequence is kept secret in sealed but 
opaque envelopes and will not be opened until enrollment, therefore lowering the 
chances of selection bias. 
7.2 Blinding Procedures 
Given the nature of the intervention, blinding participants and caregivers would not 
be feasible. However, outcome assessors, especially the nurses responsible for data 
collection, will remain unaware of group assignments. This single-blind design aims 
to reduce observer bias during data recording and interpretation. 

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7.3 Contamination Prevention 
To prevent contamination, sessions for the intervention group will take place in a 
separate location (e.g., an educational room away from clinical areas) distinct from 
control group activities. Access to QR code videos will be password-protected for 
the intervention group, ensuring that control participants do not receive any 
intervention materials. 
7.4 Duration 
The intervention will last for 4 weeks, with data collection points at baseline (T0), 
immediately post-intervention (T1), and 3 months post-intervention (T2) to evaluate 
both short-term and sustained effects. 
8. Sampling Method and Sample Size Planning 
A simple random sampling method will be applied to recruit participants from the 
ambulatory chemotherapy day center of Hong Kong Children’s Hospital (HKCH), 
where a list of all eligible attendees at the center is randomly generated by a computer. 
The decision to recruit day patients rather than hospitalized patients for the study of the 
Dreamcatchers Programme is grounded in practical, methodological, and 
generalizability considerations. 
Pediatric oncology patients typically do not remain hospitalized indefinitely. 
Hospitalizations are often episodic, tied to specific treatment phases (e.g., 
chemotherapy cycles, management of complications), and vary in duration depending 
on the individual’s condition and progress. In contrast, day patients regularly attend 
ambulatory chemotherapy day centers for scheduled treatments and are discharged 
afterwards, providing a more stable recruitment pool. The predictable attendance 
pattern allows consistent intervention delivery during their visits and facilitates 
adherence to the intervention schedule (weekly in-person follow-ups) and data 
collection at baseline (T0), post-intervention (T1), and 3-month follow-up (T2). By 
recruiting day patients, the study minimizes disruptions caused by fluctuating 
hospitalization status, ensuring feasibility for this pilot RCT. 
Secondly, the Dreamcatchers Programme is designed as a non-pharmacological 

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intervention intended for use in both hospital and home settings. Recruiting day patients 
better aligns with the programme’s adaptability, allowing the intervention to be tested 
in the setting where it is most likely to be applied long-term. 
Despite hospitalized patients are accessible during their inpatient stay, they face unique 
environmental constraints (e.g. medical equipment, frequent nursing interruptions) that 
may limit the applicability of certain intervention components, such as creating a sleep-
conducive environment. These hospital-specific barriers could confound results and 
obscure the intervention’s true potential in home settings. Day patients, practicing the 
intervention at home, provide a more representative sample for evaluating its 
generalizability, as their sleep environment reflect those experienced by pediatric 
oncology patients post-treatment or during survivorship.  
Furthermore, testing the intervention among day patients ensures that the protocol is 
feasible for children managing outpatient treatment schedules, enhancing the 
programme’s external validity. By contrast, an inpatient-focused study might yield 
results less applicable to the broader pediatric oncology population, limiting the 
programme’s scalability. 
8.1 Eligibility Criteria 
Principal investigator will approach those who are eligible, inform and ask for 
consent from caregivers and also assent from children when possible. The purpose 
of this approach is to avoid selection bias and improve the sample’s relevance in the 
clinical environment. 
Participants must meet the following inclusion criteria: 
 
Children who can read and communicate in Chinese 
 
Aged 6 to 12 years old (school-aged children). 
 
Diagnosed with cancer and currently undergoing active treatment. 
 
Identified as experiencing sleep disturbances, defined by a Chinese Pittsburgh 
Sleep Quality Index (PSQI) global score of ≥5. 
 

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The following exclusion criteria will apply: 
 
Diagnosed with hematological diseases unrelated to cancer (e.g., sickle cell 
anemia, thalassemia). 
 
Presence of severe cognitive impairment, which may hinder the ability to 
follow instructions or engage with intervention components. 
These criteria are designed to select participants who are both clinically relevant and 
developmentally capable of participating in the intervention and completing required 
assessments. 
8.2 Sample Size Planning 
As this is a pilot feasibility study, the sample size is determined based on guidelines 
for evaluating preliminary interventions rather than hypothesis testing. According to 
Teresi et al. (2022), a minimum of 30 participants per group is generally sufficient 
for feasibility trials. To accommodate an estimated 10% attrition rate at the four-week 
post-intervention assessment, a total sample of 68 participants will be recruited, with 
34 allocated to each group. An initial target of 10 participants (and their parents/legal 
guardians) from the intervention group will be invited for semi-structured interview 
for process evaluation. The analysis will continue until data saturation is achieved. 
9. Description of the Evidence-Based Protocol 
The Dreamcatchers Programme is a multi-component intervention, focusing on sleep 
hygiene education, PMR, and breathing exercises, is designed to address sleep 
disturbances in pediatric oncology patients through non-pharmacological approach. 
The programme is simple, feasible, and can be adapted to both hospital and home 
settings. It also involves a structured education, practice, and follow-up approach to 
make sure patients and caregivers are consistently able to put the intervention into play. 
9.1. Sleep Hygiene Education 
The first part of the intervention consists of a group education session on sleep 
hygiene for pediatric oncology patients and their caregivers. Each session will 
accommodate a maximum of 10 participants and will last approximately 45 minutes 
as informed by (2019), Sriasih et al. (2019), and Zupanec et al. (2017), facilitated by 

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a nurse using a PowerPoint presentation. The session will begin with highlighting 
how sleep contributes to recovery and general well-being. Next, strategies for 
creating an optimal sleep environment will be covered, including controlling lighting 
and noise that may disrupt sleep. The importance of establishing a consistent bedtime 
routine will be stressed, reminding them to maintain these practices at hospital or at 
home. 
Suggestions of screen-free activities, along with alternative activities to engage 
children without interfering with their sleep will be discussed. Caregivers will learn 
techniques of diaphragmatic breathing and PMR to promote relaxation, further 
aiding sleep improvement. 
Finally, patients and caregivers will learn how to complete the sleep diary so they 
can monitor children’s sleep habits, how much they sleep, and whether they perform 
the recommended exercises. They will get the sleep diary as a booklet that covers the 
summary of what makes for positive sleep habits. The resource can assist caregivers 
and health professionals as a useful tool in seeing the progress made and helping 
improve sleep for young cancer patients. Patients and caregivers will be reminded to 
bring the sleep diary to follow-up appointments for review and data collection. 
9.2. Progressive Muscle Relaxation (PMR)  
Following the education session, practical demonstrations of PMR and breathing 
exercises will be conducted, allowing patients and caregivers to practice what they 
have learned. These exercises will be designed to be simple, age-appropriate, and 
easily integrated into daily routines. 
Despite previous studies show that the effectiveness of PMR is not always high, the 
Dreamcatchers Programme includes PMR as it is seen as manageable for improving 
sleep time and quality (Khoirunnisa et al., 2019; Sulistyawati et al., 2021; Zupanec 
et al., 2017). PMR helps lower stress and anxiety by modulating the activities of the 
autonomic nervous system (Sari et al., 2024). The gentle movements in PMR make 
it possible for patients with less strength or mobility, as opposed to doing stretches, 
which might be difficult because of related issues like pain or weakness. PMR’s 
simplicity ensures high adherence and ease of implementation in clinical or home 

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settings, aligning with the feasibility focus of a pilot study. Although stretching 
exercises are beneficial for physical health, there is insufficient evidence 
demonstrating stretching being able to improve sleep quality or address the 
psychological factors prevalent in this fragile population. The entire PMR routine 
will take approximately 10-15 minutes, consistent with the duration of relaxation 
exercises noted in earlier research. 
9.3. Breathing Exercises 
Breathing exercises will also be demonstrated and advised to be used before bedtime, 
aiming to reduce physiological arousal and promote relaxation through slowing 
down breathing rate, amplifying vagus nerve activity and normalizing stress 
responses (Chen et al., 2016; Chui et al., 2021). This intervention will specifically 
utilize diaphragmatic breathing control exercises, which are shown to enhance tidal 
volume and regulate breathing patterns (Zaccaro et al., 2018). The breathing routine, 
incorporating box breathing techniques, will last 5-10 minutes and is to be practiced 
as part of the children’s wind-down routine before sleep (Murphy, 2019). 
To support consistent practice, a video recording of the PMR and breathing exercises 
will be provided via QR code with reference to Student Health Service’s (2016) 
materials, integrated into the sleep diaries for easy reference by patients and 
caregivers. 
The participants will be supported after the first introductory session through weekly 
follow-up sessions for four weeks. These sessions are meant to repeat and practice 
the techniques learnt, solve any doubts, and monitor participants’ sleep hygiene 
practices. Regular check-ups help to maintain contact and offer support to everyone 
involved in the treatment. 
Nurses will play a key role in delivering sleep hygiene education, demonstrating 
exercises to patients and caregivers, and conducting follow-up sessions. The 
principal investigator will train nurses covering sleep hygiene principles, techniques 
of breathing and PMR exercises, instructions on charting the sleep diary. Trained 
nurses will conduct mock demonstrations of the group education session and 
individual exercise demonstrations with their peers. The entire training programme 

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will take around one week before the actual implementation of the intervention. 
Trained nursing staff then lead the group education session covering sleep hygiene 
principles, techniques of breathing and PMR exercises.  
10. Data Collection Methods and Procedures 
Data collection for this pilot RCT will occur at three time points: baseline (T0), 
immediate post-intervention (T1), and a 3-month follow-up (T2). A summary table of 
intervention and data collection methods and procedures is included in Appendix II. 
10.1 Participant Recruitment 
Participants will be recruited at ambulatory chemotherapy day centers at HKCH. 
Trained personnels will approach eligible families, provide study details, and obtain 
informed consent from parents/legal guardians as well as child assent when 
appropriate. After consent is obtained, participants will be randomly assigned to 
either the intervention group or the waitlist control group using a concealed block 
randomization method, managed by an independent researcher to minimize bias. 
10.2 Baseline Assessment (T0) 
At enrollment, all participants will complete the following assessments: demographic 
survey for data on age, gender, cancer type, and treatment phase, Chinese version of 
the PSQI for evaluating subjective sleep quality, Chinese PedsQL Cancer Module 3.0 
for assessing quality of life, and sleep diary to track sleep patterns and exercise 
frequency (only for intervention group). 
10.3 Post-intervention Assessment (T1) 
Immediately following the four-week intervention period, all participants will 
undergo repeat assessments identical to those performed at T0, including Chinese 
PSQI, Chinese PedsQL Cancer Module 3.0, and sleep diary review. 
In addition, participants in the intervention group will complete a satisfaction survey 
and semi-structured interview with both quantitative Likert-scale items and open-
ended questions. 
 

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10.4 Three-month Follow-up (T2) 
To assess the durability of the intervention effects, participants will complete a third 
round of assessments, including Chinese PSQI, Chinese PedsQL Cancer Module 3.0 
and sleep diary review. 
10.5 Data Integrity and Confidentiality 
All research data will comply with Hospital Authority policies on the handling, 
storage, and destruction of medical records. Data collected, including demographic 
information and assessments (e.g., Chinese version of the PSQI and PedsQL Cancer 
Module 3.0), will be de-identified using unique participant codes instead of names. 
These codes will be stored separately in a password-protected electronic file 
accessible only to authorized personnel. Physical records, such as consent forms, will 
be securely locked in a ward manager’s office at HKCH. Electronic data will be 
stored on an encrypted, institution-approved server to safeguard protected health 
information. Access will be restricted to the principal investigator and trained 
research staff, with no identifiable information disclosed in publications. 
Data will be retained for five years post-study and then securely destroyed, with 
paper records shredded and electronic files permanently deleted. In the event of 
incidental findings, such as severe sleep disturbances, the research team will notify 
the participant’s parents and medical team while keeping confidentiality. 
11. Instruments 
A combination of subjective instruments will be used in this study to capture a 
comprehensive understanding of the participants’ sleep quality and overall well-being. 
The selected tools have been validated for use in pediatric populations and adapted for 
Chinese children. The authors of the Chinese versions of the PSQI and the PedsQL 
Cancer Module 3.0 have been contacted and have provided these instruments for use in 
this study.  
The decision to utilize subjective measures rather than objective tools like wrist 
actigraphy, which focuses on what patients feel and experience, and offers more 
practical and suitable ways to meet the special requirements of this group. Objective 

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tools like wrist actigraphy, require wearing devices for a period that may cause 
discomfort or anxiety, especially for those with medical devices or skin sensitivities. 
Young children might remove these devices during sleep or play, leading to incomplete 
data. It is not necessary to spend significant resources on logistics and finances for 
actigraphy in a pilot study. Alternatively, sleep diaries and the PSQI provide insights 
into the pattern and quality of participant’s sleep. The reliability, validity, and feasibility 
of each instrument have been carefully considered to minimize participant burden while 
maximizing data quality. 
11.1 Chinese Version of the PSQI 
The PSQI is used broadly to assess subjective sleep quality for the past month. There 
are seven components in the tool (including sleep latency, disturbances, and duration) 
that result in a global score of 0 to 21, with higher numbers reflecting worse sleep 
quality. The Chinese version has been validated for use among Chinese pediatric 
oncology populations, with Ho et al. (2021) reporting a Cronbach’s alpha of 0.71, 
indicating acceptable internal consistency. The same study reported an intraclass 
correlation coefficient of 0.90, reflecting excellent test–retest reliability. There is 
strong agreement between the results from this tool and results from actigraphy. 
11.2 Chinese Version of the PedsQL Cancer Module 3.0 
The Chinese PedsQL Cancer Module 3.0 allows the measurement of quality of life 
in cancer children aged 2-18, examining issues such as pain, fatigue, and cognitive 
problems. Better health-related quality of life is indicated by a high score. Lau et.al. 
(2010) found that the overall score had high internal consistency with Cronbach’s 
alpha of 0.87 among Chinese pediatric oncology patients. Study by Li et al. (2013) 
supported the construct validity of the Chinese version, as a strong positive link 
between children’s self-esteem and quality of life (r = 0.50) and a strong negative 
correlation between treatment-related symptoms and quality of life (r = -0.65) was 
recorded. 
11.3 Sleep Diary 
Participants will be asked to complete the sleep diary throughout the study period. It 
tracks bedtime, wake time, perceived sleep quality, and specific for intervention 

18 
 
group – adherence to PMR and breathing exercises, while also including QR codes 
that link to instructional videos. While the sleep diary is not validated 
psychometrically, it helps capture real-life behaviors and participant’s adherence to 
the programme. 
11.4 Satisfaction Survey 
The satisfaction survey is custom-designed that combines Likert-scale items and 
open-ended questions to assess the acceptability, usability, and perceived benefits of 
the Dreamcatchers Programme, only to intervention group at T1. The content 
includes items that evaluate the clarity of educational material, ease of performing 
exercises, and overall satisfaction with the programme. Quantitative responses will 
be analyzed descriptively, while qualitative responses will undergo thematic coding 
to identify common feedback patterns that can inform future refinements. 
11.5 
Semi-structured Interview 
Supplementing the satisfaction survey, a semi-structured interview will be conducted 
with an interview guide provided for process evaluation. A total of 10 participants 
and their parents or legal guardians from the intervention will be invited for the 
interview. However, the final sample size will depend on the data saturation. An in-
depth, one-on-one, audiotaped, semi-structured interview will be conducted with the 
10 participants and their parents or legal guardians.  
12. Data Analysis 
The data analysis will evaluate the intervention’s impact on sleep quality, duration, 
quality of life, as well as its feasibility and acceptability, comparing results against 
baseline measurements. For the Chinese PSQI, global and component scores will be 
compared between groups at T1 and T2 using independent t-tests, while repeated-
measures ANOVA will assess group-by-time effects, specifically focusing on changes 
in subjective sleep quality from baseline to T1 and T2 to assess the intervention’s impact 
over time.  
Regarding the Chinese PedsQL Cancer Module 3.0, total and subscale scores will be 
compared to baseline and between groups at T1 and T2 using independent t-tests, with 

19 
 
repeated-measures ANOVA evaluating group-by-time effects for quality-of-life 
improvements. Descriptive statistics will summarize adherence rates, intervention 
practice frequency for the intervention group, confirming protocol fidelity.  
For the satisfaction survey, quantitative analysis will involve calculating mean Likert 
scores per question, such as ease of understanding, usability, while qualitative analysis 
will use thematic coding of open-ended responses to identify common feedback themes, 
such as preferred components, for programme refinement.  
This comprehensive analysis aims to assess acceptability, feasibility, and areas for 
programme refinement, using baseline comparisons to gauge intervention effectiveness. 
The qualitative data analysis process will begin immediately after each interview, 
following the thematic analysis framework introduced by Braun and Clarke (2006). 
13. Parental Consent and Children’s Assent 
Consent from parents or legal guardians and assent from children should be sought in 
ensuring the ethical participation of children with cancer in this study. 
Informed consent will be obtained from the parents or legal guardians of all participants 
prior to enrollment. Full information about the purpose of the study, along with the 
intervention procedures, expected duration, risks involved and possible benefits will be 
provided. Clarity about data collection, the voluntary aspect, and the right to withdraw 
their child is communicated both verbally and in writing. Participation in the study will 
not affect the medical treatment received at HKCH. Parents or legal guardians will be 
informed of confidentiality measures and mild risks, including slight emotional upsets 
from talking about sleep problems. They will maintain the right to ask questions and 
sign the consent form only after indicating full understanding and agreement. 
Apart from parental consent, age-appropriate assent will be sought from children aged 
6 years and older, recognizing their capability of understanding the research. The assent 
process will be adjusted to fit the child’s age and health. Since children with cancer may 
be more familiar with medical contexts, the explanation will consider their experiences 
while remaining concise and engaging. Research staff will use simple, age-appropriate 
language to describe what process would be involved, including answering questions 
about sleep through their parents/legal guardians or research staff. Children will be 

20 
 
reassured that no invasive or painful procedures, that they can stop at any time, and 
their decision will not impact on their treatment or care. Depending on children’s ability 
and preference, assent can be documented via signature or recorded verbally, ensuring 
their willingness is acknowledged. If a child expresses reluctance or distress, even with 
parents or level guardian’s approval, their involvement will be discontinued to prioritize 
their well-being. 
14. Ethical Approval and Considerations 
Ethical approval from the Joint CUHK-NTEC Clinical Research Ethics Committee 
(CREC) and Hospital Authority Central Institutional Review Board (IRB) will be 
obtained before any data collection. The process helps guarantee that the research 
process, participant recruitment and data control follow ethical guidelines. The CREC 
and IRB will assess that there are more benefits to the study than risks, ensuring not to 
cause additional stress or pain to the participants. Parents or legal guardians should be 
provided with the details needed for informed consent and assent would be sought for 
children between the ages of 6 and 12 according to HKCH recommendations. All 
participants and their families will be fully informed about the study’s purposes and be 
given the choice to withdraw from it without any changes to their care. 
In order to ensure fairness, participants of the waitlist control group will be given access 
to the Dreamcatchers Programme once the final follow-up assessment is completed. As 
a result, all children attending the study are able to get the benefits, regardless of which 
group they were placed in. 
The issue of confidentiality will be solved by recording the data in a manner that does 
not allow the participants to be identified (i.e. using a non-recognizable code for each 
patient). The study will be conducted in compliance with Declaration of Helsinki. 
15. Significance of the Study 
The Dreamcatchers Programme has significant implications for nursing practice and 
the care of pediatric oncology patients. This intervention aims to increase sleep duration 
by at least 30 minutes (Meltzer et al., 2012), reduce PSQI scores by 2 points or more 
(Ho et al., 2022), and raise PedsQL scores by 5 points or more (Ji et al., 2011). These 
improvements are expected to enhance not only the quality of sleep but also the overall 

21 
 
quality of life for young oncology patients. 
The intervention programme allows healthcare professionals to opt for safer care 
practices, which is an important consideration for this vulnerable group. Furthermore, 
the programme helps nurses gain in-depth knowledge of sleep disturbances and 
increases their confidence when offering comprehensive care. As a result, nurses are 
better equipped to support cancer children with sleep disturbances and enhance their 
overall well-being. 
The RCT serves as a foundational step toward in creating a consistent sleep 
management practice to address the absence of standardized practices in pediatric 
oncology care in Hong Kong. Positive results from this study will demonstrate the 
efficacy of the Dreamcatchers Programme in clinical settings, and encourage more 
extensive studies and wider usage. 
The Dreamcatchers Programme seeks to achieve both better health outcomes for 
patients and to develop proactive, well-rounded sleep care by nurses in the long term. 
This achievement sets a standard for future improvements in pediatric oncology, so that 
sleep management will always be part of family-centered care. The programme could 
greatly benefit pediatric oncology patients, both at a local level and all over the world. 
 
 
 

22 
 
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28 
 
Appendix I: Summary of Literature 
Bibliographic 
Citation 
Intervention 
Duration 
Category 
Effect 
Liu et al., 2019 
Music therapy + 
Mindfulness 
8 sessions (2.5 – 3 hours per session) for 8 
weeks 
Complementary + 
psychoeducational 
Sleep quality improved post-
intervention and between 
groups 
Sriasih et al., 2019 
Music therapy + 
Education 
15 mins music playing before sleep for 3 
days 
Sleep quality improved post-
intervention and between 
groups 
Zupanec et al., 2017 
Relaxation + Education  4 weeks 
Psychoeducation + 
Cognitive behavioural  
Increased sleep time for 
intervention group 
Rogers et al., 2019 
Relaxation + Education 
+ Stimulus control 
5 days (with 90 minutes protected sleep 
time for stimulus control) 
Insignificant differences 
Sulistyawati et al., 
2021 
Muscle relaxation 
15 mins session twice per day for 7 days 
Cognitive behavioural 
Insignificant differences 
Khoirunnisa et al., 
2019 
Muscle relaxation + 
Exercise 
15 mins for 5 days 
Cognitive behavioural 
+ Physical 
Sleep quality improved post-
intervention and between 
groups 
Tanriverdi et al., 
2022 
Virtual-reality based 
exercise 
45 mins session 2 days per week for 12 
weeks 
Physical 
Insignificant differences 
Hinds et al., 2007 
Exercise (pedaling 
bicycle) 
30 mins twice daily for 2-4 days 
Insignificant differences 
Jacobs et al., 2016 
Massage 
20-30 mins for 2-3 nights 
Complementary 
Insignificant differences 

29 
 
Appendix II - Intervention and Data Collection Methods and Procedures  
Stage 
Description 
Assessments/Activities 
Participants 
Notes 
Recruitment and 
Consent 
Recruitment occurs at ambulatory 
chemotherapy day centers at HKCH. 
Trained research nurses approach eligible 
families, provide study details, and obtain 
informed consent from caregivers and child 
assent when appropriate. 
None 
All eligible 
participants 
Consent and assent obtained 
prior to randomization. 
Randomization 
and Allocation 
Participants are randomly assigned to 
intervention or waitlist control group using 
concealed block randomization managed by 
an independent researcher to minimize bias. 
None 
All participants 
Ensures balanced group 
allocation; performed after 
consent. 
Baseline 
Assessment (T0) 
Conducted at enrollment to establish 
baseline measures. Assessments include: 
 
Demographic survey (age, gender, 
cancer type, treatment phase) 
 
Chinese PSQI (subjective sleep 
quality) 
 
Chinese PedsQL Cancer Module 3.0 
(quality of life) 
Demographic survey, Chinese 
PSQI, Chinese PedsQL Cancer 
Module v3.0 
All participants 
Performed after 
randomization.  
Intervention 
Group: 
Introductory 
Session 
A total of 60 mins nurse-led group session at 
education room at HKCH introduces the 
intervention for up to 10 children and 
caregivers. includes: 
 
45 mins sleep hygiene education 
(role of sleep, optimizing sleep 
environment, addressing poor sleep 
habits) 
 
Demonstration of box-breathing (4-
4-4-4 cycle, 5–10 mins nightly) 
 
Demonstration of PMR 
(tensing/relaxing muscle groups, 
10–15 mins nightly) 
Sleep diary distribution 
(intervention group) 
Intervention 
group only 
Child-friendly instructions 
(e.g., “squeeze a lemon” for 
PMR) ensure engagement. 

30 
 
 
Distribution of sleep diaries with 
QR code videos for home practice 
Weekly Follow-
Ups (Weeks 1–3) 
Weekly in-person sessions at the Integrated 
Rehabilitation Center reinforce intervention 
techniques. Nurses: 
 
Re-demonstrate box-breathing and 
PMR 
 
Review sleep diaries to check 
adherence to nightly practice 
 
Address challenges and clarify 
techniques 
Sleep diary review (intervention 
group) 
Intervention 
group only 
Ensures fidelity and supports 
adherence. Control group 
receives general health 
education to prevent 
contamination. 
Immediate Post-
Intervention 
Assessment (T1) 
Conducted at the end of the 4-week 
intervention to evaluate short-term effects 
and adherence. Assessments include: 
 
 
Chinese PSQI (sleep quality) 
 
Chinese PedsQL (quality of life) 
 
Sleep diary review (intervention 
group adherence) 
 
Satisfaction survey, semi-structured 
interview (intervention group) 
Chinese PSQI, Chinese PedsQL, 
review of sleep diary (intervention 
group), satisfaction survey and 
semi-structured interview 
(intervention group) 
All participants 
(intervention 
and control) 
Satisfaction survey and semi-
structured interview includes 
Likert-scale and open-ended 
questions. Sleep diaries 
collected from intervention 
group to track exercises 
adherence. 
Regular Follow-
Ups (Post-
Intervention to 3 
Months) 
Monthly follow-up sessions monitor 
sustained practice and address ongoing 
challenges for the intervention group. 
Nurses review sleep diaries and provide 
support for continued PMR and breathing 
exercise practice. 
Sleep diary review (intervention 
group) 
Intervention 
group only 
Ensures continued 
engagement and adherence 
post-intervention. 
Three-Month 
Follow-Up 
Assessment (T2) 
Conducted 3 months post-intervention to 
assess durability of effects. Assessments 
include: 
 
Chinese PSQI (sleep quality) 
 
Chinese PedsQL (quality of life) 
 
Sleep diary review (adherence, 
sleep patterns, intervention group) 
Chinese PSQI, Chinese PedsQL, 
Sleep diary (intervention group) 
All participants  Sleep diaries collected from 
intervention group to evaluate 
sustained adherence.