Effects of Mindfulness Meditation on Trait Mindfulness, Perceived Stress, Emotion Regulation, and Quality of Life in Hemodialysis Patients: A Randomized Controlled Trial
Phase: NA
Conditions: Chronic Kidney Diseases, Hemodialysis Complication
Sponsor: Jordan University of Science and Technology

EFFECTS OF MBCP IN HEMODIALYSIS PATIENTS                                                            1 
 
Effects of Mindfulness Meditation on Trait Mindfulness, Perceived Stress, Emotion 
Regulation, and Quality of Life in Hemodialysis Patients: A Randomized Controlled 
Trial 
Study Protocol  
Document Date: October 29, 2020  
NCT number: Not yet issued 
 
 
 
 

EFFECTS OF MBCP IN HEMODIALYSIS PATIENTS                                                            1 
Introduction 
End-stage renal disease (ESRD) has been reported to be a major cause of disability 
and increased mortality worldwide. In patients with ESRD, hemodialysis is a critically 
vital therapy that prolongs survival and improves quality of life through the excretion or 
removal of poisonous metabolic waste from the human body (1). However, compliance 
with treatment has been found to be poor among ESRD patients (2). Such incompliance 
can be attributed to the different sources of stress associated with hemodialysis, including 
hemodialysis complications, time-consuming treatment schedules, restriction of dietary 
and fluid intake, and prescription of multiple medications (3, 4). These sources of stress, in 
addition to the signs and symptoms of ESRD, result in diminished health-related quality of 
life, which is associated with increased risks of morbidity, mortality, and incompliance 
with hemodialysis therapy (3, 5). 
Despite the significant physical, emotional, and social burdens of stress, stress-
reduction strategies have been inadequately used in patients undergoing hemodialysis. This 
may be contributed to the small-scale studies on psychotherapies with variable and holistic 
outcomes and the limited availability of evidenced-based coping interventions that are 
significantly supported (6). Mind-body therapies, which comprise a variety of techniques 
that increase the capacity of the mind to influence the functions of the body using 
emotional strategies, have gained increasing popularity worldwide in recent years. 
Evidence shows that mind-body therapies are affordable, easily-practiced, and safe, and 
that they improve perceived stress, health-related outcomes, and quality of life among 
various community-dwelling and clinical populations (7, 8). One of the most popular 
mind-body therapies in the literature is mindfulness meditation, which has been found to 
be a feasible, beneficial, and well-tolerated therapy in hemodialysis patients (6). 
 

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It is theoretically claimed that mindfulness meditation can positively impact 
perceived stress, known also as stress appraisal, and quality of life through the 
improvement of trait mindfulness and emotion regulation (9). Hemodialysis is appraised as 
an uncontrollable, threatening situation, since hemodialysis patients must undergo 
hemodialysis for their entire lives for survival. Therefore, hemodialysis is not a cure for 
terminal renal diseases but rather a maintenance therapy (10). It is claimed that repeated 
mindfulness-based practices cultivate and improve the natural mental capacity of 
mindfulness, called trait mindfulness (9). Trait mindfulness is described as the mental 
capacity to pay attention to, be aware of, and accept current experiences in a non-
judgmental way (11). This developed mental capacity enables psychological distance 
through a process of decentered attention, through which one’s attention (e.g., thoughts, 
emotions, and sensations) shifts from the contents of consciousness to the process of 
consciousness itself. In turn, this can help to stop initial automatic uncontrollable 
appraisals and broaden attention and awareness to include previously overlooked positive 
aspects of self, context, or events. Based on this new information, it becomes possible to 
flexibly select adaptive responses and to reappraise events as beneficial or meaningful (i.e., 
positive reappraisals). Trait mindfulness also enables individuals to acknowledge and 
accept their current experiences, even if these experiences are uncomfortable. In addition, 
trait mindfulness helps individuals to not engage in judgmental or negative thinking or 
avoidance of these experiences, resulting in less reactivity to stressful situations and 
increased quality of life (9, 10). 
Research supports these theoretical claims, whereby mindfulness meditation has 
been found to be highly effective for a variety of health outcomes in several psychiatric 
and medical illnesses (8, 12). For patients undergoing hemodialysis specifically, few 
studies have demonstrated that mindfulness meditation significantly improves trait 

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mindfulness (13, 14), stress symptoms (14, 15), emotion regulation (16), and quality of life 
and general health (15, 17) in Western and Asian countries. However, no study has 
examined the effectiveness of mindfulness-based interventions among ESRD patients 
undergoing hemodialysis in the Arab countries such as Kuwait. Therefore, any 
generalization of these previous study findings to other hemodialysis patients of different 
cultures such as ESRD patients in Kuwait is limited due to the different belief systems and 
self-care practices of these cultures. Thus, the current study aimed to examine the effects of 
a mindfulness-based intervention on trait mindfulness, perceived stress, emotion 
regulation, and health-related quality of life in ESRD patients undergoing hemodialysis in 
Kuwait.  
Theoretically, investigating the effects of mindfulness meditation on the selected 
variables may provide insight into the mechanisms through which mindfulness meditation 
impacts quality of life in hemodialysis patients. The current study findings may enrich the 
body of knowledge on mindfulness meditation and bridge the gap in the literature 
regarding the effects of mindfulness meditation on patients receiving hemodialysis. 
Practically, the findings of the present study may guide decision-makers in adopting 
mindfulness meditation in Kuwaiti hospitals.  
Methods 
Design 
This study used a repeated-measures, randomized, wait-list, control design and was 
conducted between January 2021 and May 2021 in the dialysis center at Jahra Hospital, 
Kuwait. Seventy-four ESRD patients undergoing hemodialysis were recruited using 
convenience sampling. Jahra Hospital is a governmental hospital with one of the biggest 
dialysis centers in Kuwait, with a female ward, male ward, and isolation ward. The center 
holds 70 dialysis machines/beds, with an average number of 30 patients managed per day. 

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The inclusion criteria for participation in this study were being a patient with ESRD 
undergoing hemodialysis three times a week, being aged 18 years old or over, and being 
able to read and write in Arabic. The exclusion criteria included being a patient with 
cognitive dysfunction or mental retardation, taking psychopharmacological drugs, or 
undergoing psychotherapy. A research assistant, who was not involved in the recruitment 
or patient assessment processes, randomly assigned the participants to the intervention 
group (n=37) or the control group (n=37) using a simple 1:1 computer-generated sequence. 
The trial is reported in accordance with the CONSORT guideline. 
Determination of the Sample Size 
The required sample size was calculated using G-power version (3.1). Given a 
mixed-design (within groups and between groups) repeated measures ANOVA, power of 
0.95, moderate effect size of 0.25, and α of .0125, the required sample size was 56 
subjects. A P-value of 0.0125 was set as the significance level for the main analysis tests. 
The p-value was adjusted due to multiple testing by dividing the p-value of .05 by 4 
(number of dependent variables). In a similar study, an attrition rate of 30% and a non-
attendance rate of 30% (excluding dropouts) were estimated (18). Thus, taking into 
consideration of 60% attrition and nonattendance rates, the final total sample size was 89 
patients.  
Data Collection Instruments 
The study data were collected using an Arabic self-report questionnaire with five 
parts: 
Demographic characteristics. This section included a question for each following 
variable: Age, gender, employment status, nationality, family status, and educational 
levels.  

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Trait mindfulness. Mindfulness is defined as open or receptive awareness of and 
attention to what is taking place in the present (19). An Arabic version of the Mindful 
Attention Awareness Scale (MAAS) was used to measure trait mindfulness (20). The 
MAAS is one-dimensional and comprises 15 items measured on a six-point Likert-type 
scale ranging from 1 (almost always) to 6 (almost never). The score range is between 15 
and 90, with higher scores indicating higher levels of trait mindfulness. The original scale 
has shown strong psychometric properties when validated among college students. The 
scale showed single-factor construct and a Chronbach's alpha of 0.82 among a sample of 
university students (19). Correlational, quasi-experimental, and laboratory studies have 
shown that the MAAS taps a unique quality of consciousness that is related to, and 
predictive of, a variety of self-regulation and well-being constructs (19). The Arabic 
MAAS has been shown to have excellent internal consistency and convergent validity 
among an Arab population (20). In our study, the Chronbach’s alpha values for the MAAS 
was 0.93.  
Perceived stress. The Arabic version of the Perceived Stress Scale (PSS) was used 
to measure the degree to which situations in one’s life are appraised as stressful 
(unpredictable, uncontrollable, or overloaded) (21). The scale comprises 10 items which 
are measured on a 5-point Likert scale (0=never, 4= very often) and which are relatively 
free of content specific to any subpopulation group. The total possible score ranges from 0 
to 40, with higher scores indicating higher levels of perceived stress (stress appraisal) (22]. 
The PSS has been validated for use among college students. The internal consistency 
coefficient for the PSS is .84 and the scale’s test-retest reliability is .85 (22]. The Arabic 
PSS has been shown to have adequate reliability and validity and is considered a suitable 
instrument for assessing perceived stress in Arab people (21]. the Chronbach’s alpha 
values for the PSS was 0.82.  

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Emotion regulation. Emotion regulation is defined as the processes by which 
individuals influence which emotions they have and how they experience and express these 
emotions (24). The Arabic version of the Emotion Regulation Questionnaire (ERQ) was 
used to assess emotion regulation among the study sample (23). The questionnaire items 
are scored on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly 
agree) and are divided into two subscales, namely cognitive reappraisal and expressive 
suppression. Higher scores indicate greater emotion regulation abilities (24). The Arabic 
version of the ERQ has shown valid and reliable results among the Arab population (23). 
In our study, the Chronbach’s alpha values for the ERQ was 0.81.  
kidney disease-quality of life. The Arabic version of the kidney disease-Quality of 
Life questionnaire (KDQOL-36) is used to assess kidney disease-related quality of life and 
consists of four subscales: Generic Core (Physical Component Summary (PCS, 12 items) 
and Mental Component Summary (MCS, 12 items)); Symptoms/Problems (12 items); 
Burden of Kidney Disease (4 items), and Effects of Kidney Disease (8 items) (25). The 
scores of the different subscales are calculated according to the KDQOL-36 scoring 
system. Raw, pre-coded numeric values for each item are transformed linearly to a range of 
0 to 100, with higher scores reflecting better kidney disease-quality of life (26). The Arabic 
version used in this study showed good psychometric qualities among Arab patients with 
chronic renal failure (25). In our study, the Chronbach’s alpha values for KDQOL-36 was 
0.93.  
Intervention 
The experimental group received the Smith’s version of mindfulness meditation 
(27), which is a standardized theory-based intervention found to be effective in improving 
stress and its related health problems. The Smith’s version of mindfulness meditation (27) 
comprises the following components:  

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1. Being mindful of breathing, which includes easily taking in a full, deep breath, 
filling the lungs, simply exhaling, and then breathing naturally. It also includes 
noticing and simply attending to the air as it flows in and out of the nose and 
moves deeper into the throat and lungs (5 minutes).  
2. Being mindful of the body, which includes attending to how the body feels 
from head to toes and noticing any sensations that come and go. Upon noticing 
a sensation, the individual must gently note it, let it go, and continue attending 
to how the body feels (5 minutes). 
3. Being mindful of thought, which includes attending to the mind as thoughts 
come and go. Whenever a thought or feeling comes to mind, the individual 
should just notice it, let it go, and continue attending to the mind repeatedly (5 
minutes). 
4. Being mindful of sounds, which includes attending to the sounds one hears, 
without thinking about them. The individual must gently notice the sound, let it 
go, and continuing waiting (5 minutes). 
5. Being mindful of taste, which includes imagining a wonderful bowl of pieces of 
one’s favorite fruit and simply attending to a taste sensation, without thought, 
analysis, or effort (5 minutes) 
6. Full meditation, which includes gently opening one’s eyes and being mindful of 
the world of the moment, quietly attending, and waiting. When noticing 
something, be it a sight, sound, thought, or sensation, the individual must let it 
go and then resume attending, doing nothing else, and waiting for what comes 
next (5 minutes).  
The experimental group received 30-minute individually administered, guided, 
chairside interventions during their hemodialysis sessions. This protocol has been found to 

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be feasible and effective for patients undergoing hemodialysis (6). Smith (2005) explained 
in his ABC relaxation theory that at least two and preferably five weekly 30-minute 
sessions of actual training of mind-body therapies should be provided to evoke relaxation, 
relieve stress, and improve health in general populations. However, for hemodialysis 
patients, it has been suggested that brief program formatting with at least 400 total minutes 
may lead to greater health benefits (18). Accordingly, the experimental group received 30-
minute mindfulness meditation sessions 3 times a week for 5 weeks (450 minutes)  
The participants also received a 2-hour foundation course which was introduced 
and supervised by one of the study researchers prior to the actual training sessions and 
which taught the participants the intervention basics, benefits, protocol, and method of 
access. To ensure the consistent delivery of the intervention, the researcher recorded the 
intervention instructions in Arabic based on the Smith (2005) protocol and sent the audio-
recorded instructions to the participants via WhatsApp or email. The audio-recorded 
intervention contents were validated by 2 psychologists and experts in meditation. The 
recorded intervention instructions were accessed by the participants during the sessions 
using their cell phones and headsets, as recommended (18). This method allowed for up to 
3-5 participants to listen to the instructions and perform the intervention simultaneously.  
The researcher who was responsible for developing the study intervention and 
supervising the intervention delivery was an experienced mind-body practitioner who had 
received a 4-day training course on mindfulness meditation. The researcher attended the 
sessions to manage any potential interruptions and evaluate the intervention delivery. The 
participants’ privacy was maintained using curtains surrounding each participant during the 
intervention. The participants were asked not to share any information related to the 
intervention with the participants in the control group.  

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The participants in the control group were instructed to sit with their eyes closed 
and relaxed for 30 minutes 3 times a week for 5 weeks during hemodialysis sessions to 
control for the nonspecific effects of social interaction and environment (35). The timings 
of the control group sessions were similar to those of the experimental group, whereby if a 
given experimental group intervention lasted for 30 minutes, the control group participants 
would be asked to sit with their eyes closed and relax for 30 minutes also.  
Procedure 
First, the permission from the instruments used in the study was obtained. 
Recruitment of participants was conducted by one of the study researchers after obtaining 
approval to conduct the study from the hospital administrators. The study purposes and 
protocol were explained to the patients in detail. Patients who agreed to participate in the 
study and met the eligibility criteria were asked to sign a consent form, and the 
participating patients were then randomly assigned to the two study groups. The baseline 
measurements of the study variables were taken using the self-report questionnaires, which 
were administered by a research assistant who was not involved in any other parts of the 
study. The study variables were also measured two weeks post the start of the intervention 
and at the end of the final session for both groups under the same conditions. All 
measurements were privately taken at the dialysis center.  
Data Analysis 
 
SPSS version 25 (SPSS Inc., Chicago, Illinois, USA) was used to analyze the 
collected data. Prior to the main analysis, outliers and missing data were examined and 
managed as appropriate. Then, the assumptions of the statistical tests used, normality using 
histogram graph, homogeneity of variance, and sphericity were checked and managed as 
appropriate. Mauchly's test of sphericity is used to assess whether the sphericity 
assumption has been violated. When Mauchly's test of sphericity was significant (p < .05), 

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the degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity.  
The comparability of the two groups was evaluated in terms of demographic characteristics 
and the baseline measurements of the dependent variables using t-test and Chi square, 
based on the measurements of the dependent variables. The main analysis was conducted 
with repeated-measures ANOVA (mixed design: within and between groups). A P-value of 
0.0125 was set as the significance level for the main analysis tests. The p-value was 
adjusted due to multiple testing by dividing the p-value of .05 by 4 (number of dependent 
variables).  
Ethical Considerations 
The study proposal was approved by the Institutional Review Board at Jordan 
University of Science and Technology and the Kuwaiti Ministry of Health (Number of 
approval: 78/136/2020). The study was conducted in accordance with the Declaration of 
Helsinki. The participants were asked to sign informed consent forms which included an 
explanation of the study purpose and protocol, in addition to a statement indicating that the 
participants had the right to refuse to participate or withdraw from the study at any time 
without consequences. The participants were assured that their information would not be 
made available to others without their consent. The study data were stored in a locked 
locker after all names were replaced by numbers.  
 
 
 
 
 
 
 

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