Effects of Mindfulness Meditation on Quality of Sleep, Perceived Stress, Serum Cortisol, and C-reactive Protein in Hemodialysis Patients
Phase: NA
Conditions: End-Stage Renal Disease, Hemodialysis Complication
Sponsor: University of Jordan

 
 
 
Effects of Mindfulness Meditation on Quality of Sleep, Perceived Stress, Serum 
Cortisol, and C-reactive Protein in Hemodialysis Patients 
 
Study Protocol 
Date: September 9, 2024 
NCT Number: Not yet issued 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1. Introduction 
 
End-stage renal disease (ESRD), or kidney failure, happens when the kidneys 
almost completely stop working, usually below 10-15% of normal function (1). It has 
been documented as a significant factor in rising rates of disability and mortality 
worldwide, particularly due to the rising rates of diabetes and hypertension(1). 
Globally, the population of individuals with ESRD falls from 4.902 to 9.701 million, 
with most found in low and middle-income nations (1). In North Africa and the 
Middle East, ESRD rates exceed 500 per 100,000 population when age-standardized 
(2). In Gulf Cooperation Council (GCC) countries, the average rate of end-stage renal 
disease was 551 per million people, with Oman having the highest prevalence at 1000 
per million and Qatar the lowest at 347 per million (3). In Kuwait, there were 465 
cases of dialysis per million people, while the incidence of dialysis was 100 per 
million populations (4). 
The Global Burden of Disease reports that impaired fasting plasma glucose, 
hypertension, sodium-rich diet, heart disease, urinary tract blockages, inflammation, 
and certain genetic disorders are common risk factors for end-stage kidney disease (1, 
5). The last phase of chronic kidney disease necessitates renal replacement therapy, 
like dialysis or a kidney transplant, to ensure survival (1). Both forms of dialysis, 
hemodialysis or peritoneal dialysis, effectively eliminate toxins and excess fluids 
from the body, but they do not cure kidney disease (1). Nevertheless, hemodialysis is 
an extremely important treatment for individuals with ESRD that enhances health by 
removing toxins from the body, typically done multiple times a week and lasting 
several hours (1).  
However, the lives of ESRD patients are impacted by hemodialysis treatment, 
which brings about various physical and psychosocial stressors during their lengthy 

treatment (1). In relation to physical indications, hemodialysis patients are constantly 
in danger of experiencing intradialytic hypotension, muscle cramps, headache, 
fatigue, nausea, vomiting, itching, acute hemolysis, air embolism, bloodstream 
infections, and vascular access stenosis (6). While stress, insomnia, depression, and 
anxiety are among the psychological indicators in this group (7, 8). Additionally, most 
of these individuals have observed elevated amounts of pro-inflammatory markers in 
the blood, like C-reactive protein (9). In this situation, continual stress can harm the 
immune system by activating the hypothalamic-pituitary-adrenal (HPA) system, 
including hormones like cortisol, which rises 15 minutes after the stress situation and 
stays high for multiple hours (10, 11). During chronic stress and frequent exposure to 
stressors, a long-term elevation in cortisol levels can harm the hippocampus, reduce 
sensitivity to cortisol, and enhance cortisol binding to the mineralocorticoid receptor 
(12). When cortisol binds to the mineralocorticoid receptor, it triggers the release of 
pro-inflammatory factors like C-reactive protein (CRP) as a pro-inflammatory 
response (10) and psychological stress (13). It often leads to changes in body fluid 
balance, uremia, and frequent nocturnal muscle cramps, all of which disturb sleep 
(14). As the hemodialysis treatment often involves three or more sessions per week, 
each lasting several hours, it is taxing on the patient’s body and disrupts natural 
circadian rhythms, compounding the effects of sleep disorders (14). Sleep disorders 
such as insomnia, restless leg syndrome, and obstructive sleep apnea are common 
among hemodialysis patients, leading to fatigue, cognitive decline, and increased risk 
for depression and anxiety (15). Additionally, poor sleep can exacerbate 
cardiovascular risks, worsen pain perception, and weaken the immune system, all of 
which are critical concerns for ESRD patients (16). These issues are particularly 
problematic because they affect patients' rest, physiological recovery, and mental 

health (17). That’s why sleep quality is often severely impaired in patients with 
ESRD, with rates of sleep disturbances much higher than in the general population or 
among those with other chronic illnesses (1). 
As a result, reports have shown that ESRD patients sometimes employ 
ineffective or harmful coping strategies when facing multiple stressors, resulting in 
negative impacts on their overall physical and psychological well-being, increased 
vulnerability to infections, and higher rates of mortality and morbidity among this 
population (18, 19). On the other hand, mind-body techniques are believed to be 
beneficial for health by promoting a connection between the mind and body, 
enhancing present-moment awareness and acceptance without judgment (20). 
Mindfulness meditation, a widely practiced mind-body technique, involves focusing 
on the present moment with an attitude of acceptance and nonjudgment (21). 
Mindfulness meditation is hypothesized to target multiple cognitive and emotional 
processes that contribute to stress and poor sleep quality. It has been shown to enable 
psychological distance and positive reappraisals, helping to stop automatic, 
uncontrollable appraisals and decreasing stress and cortisol levels (22, 23). It has also 
been shown to decrease ruminative thoughts, diminish emotional reactivity, and 
promote impartial reappraisal of salient experiences, which together may facilitate 
sleep (24-27). In addition, it has been found to improve physiological indices of stress 
by cultivating stress and amygdala reactivity, resulting in decreased cortisol responses 
and pro-inflammatory markers such as CRP (28, 29). Decreased amygdala reactivity 
associated with activation of the parasympathetic nervous system decreases cortisol 
levels, which is its high prolonged levels can cause an increase in glucocorticoid 
receptor resistance to cortisol and increased circulating markers of inflammation, such 
as CRP (30). 

Smith (2005)(31) suggested in his Attentional Cognitive Behavioral (ABC2) 
Relaxation theory that two 30-minute sessions of mindfulness meditation per week 
are necessary to induce relaxation, reduce stress, and enhance overall health on the 
broader community (31). His mindfulness format has been suggested as a 
standardized format with five consecutive parts, each lasting 5 minutes, for a total 
session time of 30 minutes (31). Research has shown that this mindfulness meditation 
is as successful as the more extended method in decreasing stress levels (9, 32) . Also, 
mindfulness meditation has been shown to be a suitable therapy that improves various 
aspects of well-being in Arabic societies (33). In general, studies have shown that 
mindfulness meditation is a proven method to decrease stress and biomedical markers 
and improve sleep quality in both ESRD and other chronic patients, impacting them 
physically, emotionally, and mentally (9, 32, 34-44). 
Since mindfulness meditation offers the potential to address psychological and 
physiological symptoms in different patient groups, it has not been widely utilized in 
hemodialysis patients compared to other chronic illnesses (45). Further, sleep issues 
are often under-recognized in clinical care, especially with ESRD patients receiving 
hemodialysis despite their high prevalence and impact on health outcomes (46, 47). 
Additionally, no studies have been conducted to investigate mindfulness meditation's 
impact on sleep quality and stress levels and inflammatory markers such as serum 
cortisol and C-reactive protein among hemodialysis patients. Thus, it is essential to 
have efficient nursing strategies for managing hemodialysis to ensure the best 
possible care for this group (45, 48-50). Therefore, the main goal of this research is to 
assess how effective mindfulness meditation is in improving sleep quality, reducing 
stress levels, and impacting serum cortisol and C-reactive protein levels in end-stage 
renal disease patients undergoing hemodialysis. Practically, the findings of this 

research could advise the Kuwaiti Ministry of Health on incorporating mindfulness 
meditation in Kuwait hospitals. Theoretically, the current study could also broaden 
the nursing field's understanding and address the existing literature gap on how 
mindfulness meditation impacts sleep quality, stress perception, cortisol levels, and C-
reactive protein in hemodialysis patients in Kuwait and culturally similar countries to 
enhance disease satisfaction. 
2. Method 
2.1. Design 
This study used a repeated-measures, randomized, parallel control design and 
was conducted between September 2024 and February 2025 in the dialysis center at 
Jahra Hospital, Kuwait. The recruitment took approximately ten weeks, and the data 
collection and intervention took approximately nine weeks. Fifty-six ESRD patients 
undergoing hemodialysis were recruited using simple random 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 of 30 patients managed daily. The location was 
chosen because of its capacity to supply an adequate number of participants for the 
planned research. So, the researcher discovered that conducting an interventional 
study by enrolling patients from multiple Kuwait hospitals was costly and required a 
significant amount of time. Additionally, the researcher focusing on evaluating the 
efficacy of this treatment for ESRD patients receiving hemodialysis in Kuwait should 
prioritize addressing factors impacting internal validity over those impacting external 
validity or generalizability. Choosing a homogenous sample from a single setting is a 
method that can be used to enhance internal validity (51). 

The inclusion criteria for participation in this study were being a patient 
with ESRD undergoing hemodialysis three times a week for a minimum of one year, 
being aged 18 years old or over, having a urea reduction rate greater than 65% or 
Kt/V greater than 1.2 in the past month, and possessing Arabic literacy skills. The 
exclusion criteria included being a patient with cognitive dysfunction or mental 
retardation, suffering from rheumatoid arthritis, using a hearing aid, regularly 
consuming psychopharmacological drugs to reduce stress and improve sleep, 
participating in other psychological therapies at the time, or had prior formal training 
in mindfulness methods or a current meditation practice. Criteria for exclusion were 
built based on the chronic condition of the participants' status, which would make 
participation in the mindfulness sessions and home practice of mindfulness meditation 
problematic or distressing. Having serious psychiatric conditions, receiving 
psychopharmacological drugs, participating in other psychological or mindfulness 
therapies, or having severe hearing impairment would potentially risk failure in the 
intervention or limit participation in the mindfulness sessions. Further, patients with 
rheumatoid arthritis may have an increased burden of both age-related and disease-
related cognitive decline, and elevated C-reactive protein levels may indicate an 
inflammatory process in the body (52, 53). The trial is reported in accordance with the 
CONSORT guidelines. 
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 0.05, the required sample size was 44 
subjects. A similar study reported an attrition rate of 60% (54). Considering an 
expected attrition rate of 60%, 24 subjects should be added. Thus, the final required 
sample size was 68 participants. 

2.2. Data collection instruments 
The study data were collected using an Arabic self-report questionnaire with five 
parts. 
2.2.1. Demographic characteristics 
This section included a question for each variable: Age, gender, nationality, 
marital status, dialysis vintage, Kt/V, educational attainment, employment status, 
family status, and any comorbidities. 
2.2.2. Quality of sleep 
The Pittsburgh Sleep Quality Index (PSQI) aims to evaluate sleep quality in 
clinical populations. The PSQI includes seven dimensions of sleep characteristics: 
subjective sleep quality (1 item), sleep latency (2 items), sleep duration (1 item), 
habitual sleep efficiency (3 items), sleep disturbances (9 items), use of sleeping 
medication (1 item), and daytime dysfunction (2 items). When the PSQI is scored, 
seven different scores are calculated for each component, ranging from 0 (no 
problems) to 3 (severe problems) (55). The PSQI shows internal consistency and a 
reliability coefficient (Cronbach’s alpha) of 0.83 for its seven components (55). The 
Arabic PSQI had a Cronbach’s alpha coefficient of 0.77, indicating satisfactory 
reliability (56). The Arabic version provided accurate and dependable outcomes 
within Arabic cancer communities (56). In our study, Chronbach’s α coefficient for 
the PSQI was 0.77. 
2.2.3. Perceived stress 
The Perceived Stress Scale (PSS) assesses how stressful situations in one's life 
are perceived based on their unpredictability, lack of control, and feeling 
overwhelmed. It consists of 10 elements assessed using a 5-point Likert scale 
(0=never, 4=very often) that are mostly not specific to any particular subgroup. 

Scores range from 0 to 40, with higher scores indicating greater perceived stress 
levels (57). The PSS showed internal consistency coefficients varying from 0.84 to 
0.36 and a test-retest reliability of 0.85 (57). The Arabic PSS had a Cronbach's alpha 
coefficient of 0.80 and an intra-correlation coefficient of 0.90 for test-retest reliability, 
indicating satisfactory reliability levels (58). Almadi, Cathers, Mansour, and Chow 
(2012) (58) confirmed the suitability of PSS for Arabic individuals. The Chronbach’s 
α coefficient for the PSS was 0.76. 
2.2.4. Biomedical markers 
The Access Cortisol Assay-33600 and CRP Reagent-447280 protocols, which 
involved blood sampling, were strictly followed. The Access Cortisol Assay is a 
paramagnetic particle, competitive binding immuno-enzymatic assay for the 
quantitative determination of cortisol levels in human serum, plasma (heparin, 
EDTA), and urine using the Access Immunoassay Systems, aiding in the diagnosis of 
adrenal-related disorders (59). The CRP reagent, in conjunction with IMMAGE 
Immunochemistry Systems, is intended for the quantitative determination of C-
reactive protein (CRP) in human serum or plasma (heparin, EDTA), aiding in the 
evaluation of stress, trauma, infection, inflammation, and surgery (60).  
Both protocols were precise, specific, and sensitive in accurately measuring 
serum cortisol and C-reactive protein concentration (59, 60). It is necessary to do the 
serum cortisol test multiple times a day or several days (61). However, it is important 
to carefully consider the timing of cortisol testing because it follows a strong 
circadian rhythm, peaking during the first hour after waking up and decreasing 
throughout the day until midnight. Hence, routinely checking serum cortisol levels 
during the first hour after waking up is viewed as a consistent and trustworthy 
biological indicator (61-63). 

2.3. Intervention 
2.3.1. Experimental group 
The experimental group received the Smith’s version of mindfulness 
meditation (31), a standardized theory-based intervention found to be effective in 
improving stress and its related health problems. Smith’s version of mindfulness 
meditation (31) comprises the following components. 
(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 min). 
(2) Being mindful of the body includes attending to how the body feels from head 
to toe 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 min). 
(3) Being mindful of thought includes attending to the mind as thoughts come and go. 
Whenever a thought or feeling comes to mind, the individual should notice it, let it go, 
and continue attending to the mind repeatedly (5 min). 
(4) Being mindful of sounds includes attending to the sounds one hears without 
thinking about them. The individual must gently notice the sound, let it go, and 
continue waiting (5 min). 
(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 min) 
(6) Full meditation 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 min). 
The participants in the intervention group underwent a 30-minute mindfulness 
meditation program three times a week for eight weeks, scheduled during their 
dialysis sessions, specifically between the first and second hour of hemodialysis (64). 
The program is based on ABC2 theory and incorporates mindfulness meditation 
techniques, a standardized intervention that has been proven effective in reducing 
stress and associated health issues (31). The researcher in the study documented the 
intervention guidelines in Arabic following the protocol Smith (2005) outlined. 
Following that, two psychologists and meditation experts approved the intervention 
contents, which were recorded in audio format. Following this, the recorded audio 
instructions were forwarded to the IT developer for assessment of the intervention 
program based on functionality, design, user-friendliness, and voice quality. The IT 
technician was on standby to address any technical issues promptly. 
 
The participants were required to finish a 2-hour introductory course 
conducted in a private setting by the certified researcher before starting the training 
sessions in a room in the dialysis center. The introduction course educated the 
participants on the fundamentals, advantages, procedures, and ways to reach the 
intervention. Next, the recorded audio instructions were dispatched to the participants 
through WhatsApp and email to guarantee the uniform administration of the 
intervention. Participants followed the recommended instructions accessed via their 
cell phones and headsets during hemodialysis sessions, as documented (9, 54). The 
individualized intervention was provided and supervised directly at the patients' 
chairside while they were receiving hemodialysis treatment. The intervention delivery 

using audio-recorded instructions allowed the researcher to introduce individual 
intervention sessions for up to five participants simultaneously. 
 
This method has been shown to be both possible and successful for individuals 
receiving hemodialysis (9, 32, 54, 65). In his ABC2 relaxation theory, Smith (2005) 
(31) stated that general populations should receive at least two 30-minute sessions of 
mind-body therapy training per week to induce relaxation, alleviate stress, and 
enhance overall health. Nevertheless, it has been proposed that a concise program 
structure with a minimum of 400 minutes could increase hemodialysis patients' health 
advantages (54). Based on physical assessments, there is a theory that morning serum 
cortisol and serum C-reactive protein levels may decrease after an 8-week period of 
mindfulness-based practices (1-3 times weekly, totaling 60-180 minutes)  (66, 67). As 
a result, the experimental group participated in a 30-minute mindfulness meditation 
session three times per week for 8 weeks (720 minutes). Curtains were used to 
maintain the privacy of each participant during the intervention. Participants were 
instructed not to disclose any details about the intervention to those in the control 
group to avoid contamination. The healthcare professionals promptly addressed any 
possible interruptions, such as the alarm of the dialysis machine (peeps). Over eight 
weeks, participants were instructed to consistently practice the program at home 
before going to bed each night. 
The researcher responsible for supervising the intervention delivery was an 
advanced nursing specialist with six years of nephrology nursing experience and a 4-
day training course on mindfulness meditation. This researcher attended the sessions 
to manage any potential interruptions (e.g., machines’ peeps and interruptions) and 
evaluate the intervention delivery and compliance using checklists produced 
according to Smith’s protocol (54). After each session, the researcher completed the 

checklist by asking the participants whether they had completed all the intervention 
protocol. If the participants felt discomfort, nausea, headache, muscle tension or any 
other uncomfortable symptoms during or immediately after the intervention sessions, 
the researcher informed the participants to stop the intervention to seek and provide 
the appropriate healthcare. 
2.3.2. Control group 
The participants in the control group were instructed to sit with their eyes 
closed and relaxed for 30 min three times a week for eight weeks during hemodialysis 
sessions to control for the nonspecific effects of social interaction and environment 
(Rausch et al., 2006). 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 min, the control group participants would also be asked to sit with their eyes 
closed and relax for 30 min. 
To avoid contamination bias, the experimental group participants were 
instructed to refrain from discussing any details about the intervention with anyone 
else throughout the duration of the study. The nurses and doctors at the hemodialysis 
center were not informed about the experimental group's intervention to avoid sharing 
details with the control group participants. During the study, the control group 
participants were given a placebo intervention, which involved closing their eyes and 
relaxing for 30 minutes. The experimental group participants' hemodialysis sessions 
were rescheduled to different units from the control group for eight weeks to prevent 
contamination bias during the intervention period. The participants from the 
experimental and control groups were allocated to separate hemodialysis units within 
the hemodialysis treatment center. Approval was obtained from the participants 
before managing the rescheduling with the nurses and physicians at the hemodialysis 

center. The privacy and confidentiality of the participants were upheld by ensuring 
that no one could observe the data collection and intervention sessions through the use 
of curtains around each participant. At the end of the intervention, the researcher 
overseeing the intervention delivery confirmed with the control group participants that 
they had not engaged in or been provided with any information on mindfulness 
meditation throughout the study. 
2.4. Procedure 
First, the permission from the instruments used in the study was obtained. 
Recruitment of participants was conducted by one of the study researchers who 
supervised the intervention delivery after obtaining approval from the hospital 
administrators to conduct the study. The list of all hemodialysis patients' names for 
both male and female floors, including their personal information (age, contact 
number, dialysis unit/room, hemodialysis shifts/days, hemodialysis access, 
hemodialysis starting date, and other chronic diseases) were gathered from the 
selected dialysis center. After that, all participants' files were checked for the last 
month Kt/V scores to conduct the inclusion criteria and select the study sample. 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. Participants then completed the study variables' baseline 
measurements (T0) using the self-report questionnaires and measurements with a 
research assistant with a bachelor's nursing degree and 10 years of nephrology nursing 
experience. Another study researcher with a PhD degree, who was not involved in the 
recruitment process and data collection, randomized the participants to the 
experimental group (n = 34) or the control group (n = 34), using a simple 1∶1 
computer-generated sequence. The study variables were measured four weeks post the 

start of the intervention (immediately after the twelve session, T1) and at the end of 
the final session (T2) for both groups. The measurements of the study variables at T0, 
T1 and T2 were conducted by the same research assistant who was not involved in 
any other parts of the study and blinded to randomization allocation. All 
measurements were privately taken at the dialysis center. 
2.5. 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 a histogram graph, homogeneity of variance, and sphericity were 
checked and managed as appropriate. Mauchly’s test of sphericity is used to assess 
whether the assumption of sphericity has been violated. When Mauchly’s test of 
sphericity was significant (P < 0.05), the degrees of freedom were corrected using 
Greenhouse-Geisser or Huynh-Feldt 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 a 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 
0.05 was set as the significance level for the main analysis tests. 
 
 
 
 
 
 

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