Chapter1: Effects Of Mindfulness Meditation On Trait Mindfulness,perceived Stress, Emotion Regulation, Andquality Of Life in Hemodialysis Patients:A Randomized Controlled Trial

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A B S T R A C T

Objective: This study aimed to examine the effects of mindfulness meditation on trait mindfulness, perceived stress, emotion regulation, and quality of life in end-stage renal disease patients undergoing hemodialysis.

Methods: An experimental study with a repeated measures design was conducted among a sample of 74 end-stage renal disease patients undergoing hemodialysis between January and May 2021 in the dialysis center at Jahra hospital, Kuwait. The patients were randomly assigned to the experimental (n=37)and control groups (n = 37). The experimental group participated in 30-min mindfulness meditation sessions (three sessions a week for five weeks)held during their hemodialysis sessions; the participants in the control group were instructed to sit with their eyes closed and relaxed for 30 min three times a week for five weeks during hemodialysis sessions. The dependent variables of both groups were measured at baseline(TO), middle of intervention(T1), and end of intervention(T2) using the Mindful Attention Awareness Scale(MAAS), Perceived Stress Scale(FSS), Emotion Regulation Questionnaire(ERQ), and Kidney Disease Quality of Life(KDQOL-36) questionnaire. The study was registered in the ClinicalTrial. gov(Identifier:NCTO5176730).

Results: The repeated measures ANOVA(within-subject) results for the experimental group showed that mindfulness meditation had significantly decreased perceived stress by the end of the intervention. Also, mindfulness meditation improved mindfulness, emotion regulation, and kidney disease-related quality of life in the experimental group, and this improvement occurred significantly at both T1 and T2. The repeated measures ANOVA(within and between-subject) results showed that the experimental group, as compared to the control group, had lower perceived stress, higher trait mindfulness, higher emotional regulation, and higher kidney disease-related quality of life over time.

Conclusions: The positive findings of this study offer health policymakers and hospital administrators a promising tool to use with patients undergoing hemodialysis as a way to manage stress and improve quality of life. However, this study should be replicated in multiple settings with follow-up assessments.

What is known?

·End-stage renal disease(ESRD)has been reported to be a major cause of disability and increased mortality worldwide.

● Hemodialysis, in addition to the signs and symptoms of ESRD, was reported as a source of stress, resulting in diminished health-related quality of life.

● Mindfulness meditation has been found to be highly effective for a variety of health outcomes in several psychiatric and medical illnesses.

● Few studies have examined the effectiveness of mindfulness-based interventions among ESRD patients undergoing hemodialysis in Arab countries such as Kuwait.

What is new?

● The findings of the current study generally provided preliminary evidence about the effectiveness of mindfulness meditation as a coping tool for end-stage renal disease patients undergoing hemodialysis to manage stress and quality of life in Kuwait. ·Mindfulness meditation decreased perceived stress and increased trait mindfulness, emotion regulation, and quality of life in ESRD patients receiving hemodialysis.

●The findings of the current study added new preliminary evidence to the stress/coping field that could be used to guide hemodialysis-related clinical practice, education, and healthcare policies in Kuwait and other countries.

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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 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, and mortality, and in compliance 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].

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]. When faced with a situation, such as a hemodialysis, patients with ESRD appraise whether this situation is stressful or not [10]. Cognitive appraisal of stress is divided into primary and secondary appraisal. The primary appraisal involves appraising whether the situation is a loss, threat, challenge, or uncontrollable. Hemodialysis is usually appraised as a threatening, uncontrollable situation since patients have no choice but to undergo hemodialysis on a regular basis for their entire lives for survival [10]. Secondary cognitive appraisal of stress involves appraising and determining the available internal and external coping resources that enable patients to control and manage a stressful situation(e.g., continuous hemodialysis). Lack of coping resources may increase patients' perceived stress, consequently threatening physical and social health status and inducing

psychological maladaptation. Thus, modifying patients' secondary cognitive appraisal by increasing their coping resources may enable them to manage the perceived stress induced by hemodialysis[10].

Coping resources are often classified into four types, physical, environmental, materialistic, and psychological resources. Specifically, psychological coping resources are usually used to cope effectively with an unavoidable situation such as hemodialysis. Mindfulness mediation is a psychological coping resource that can relieve stress and the corresponding physical, psychological, and social reactions, threatening the quality of life [10]. Mindfulness meditation cultivates and improves the natural mental capacity to pay attention to, be aware of, and accept current experiences in a non-judgmental way[11]. The developed capacity of mindfulness enables patients to acknowledge and accept their overwhelming current experience of hemodialysis, even if this experience is uncomfortable. In addition, it allows patients to be aware of their responses to senses, emotions, and thoughts, which enable effective self-management and problem-solving abilities [10]. It also helps them not engage in judgmental or negative thinking or avoidance of the hemodialysis-related experiences, resulting in less reactivity to stressful situations such as emotional, physical, and social reactions [9,10].

Research supports these theoretical claims, whereby mindful-ness meditation has been found to be highly effective for a variety of health outcomes in several psychiatric and medical illnesses [7,8]. For patients undergoing hemodialysis specifically, few studies conducted in Western and Asian countries have demonstrated that mindfulness meditation significantly improves trait mindfulness [12,13], stress symptoms[13,14], emotion regulation [15], and quality of life [14]. However, these studies suffer from using very small sample sizes(e.g.,15 to 36 participants) or/and quasi-experimental designs, limiting validity[12-15]. The current study addressed these issues as a randomized controlled design and a power analysis to calculate the required sample size were used. Even though evidence-based recommendations support the use of theory-based approaches for developing and delivering interventions [16], the existing studies have not taken into consideration this aspect. Theories can help identify the components and duration of intervention and decrease variations in the delivery of intervention [16]. Therefore, the development of the intervention protocol in the current study was based on the ABC Relaxation Theory (Smith, 2005), which suggests a standardized and empirically tested version of mindfulness meditation[17]. Moreover, few studies have examined the effectiveness of mindfulness-based interventions among ESRD patients undergoing hemodialysis in 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 randomized controlled trial aimed to examine the effects of a standardized version of mindfulness meditation 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 the 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 provide a basis for decision-makers in adopting mindfulness meditation in Kuwaiti hospitals.

2. Method 

2.1. Design

This study used a repeated-measures, randomized, parallel, control design and was conducted between January and May 2021 in the dialysis center at Jahra Hospital, Kuwait. The recruitment took approximately ten weeks, and the data collection and intervention took approximately six weeks. 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. 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. The trial is reported in accordance with the CONSORT guideline.

The required sample size was calculated using the G-power version (3.1). Given a mixed-design (within groups and between groups)repeated measures ANOVA, power of 0.95, the moderate effect size of 0.25, and a. of 0.05, the required sample size was 4 subjects. In a similar study, an attrition rate of 60% was reported [17]. Considering an expected attrition rate of 60%,26 subjects should be added. Thus, the final required sample size was 70 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, employment status, nationality, family status, and educational levels.

2.2.2. Trait mindfulness

Mindfulness is defined as open or receptive awareness of and attention to what is taking place in the present [18]. An Arabic version of the Mindful Attention Awareness Scale(MAAS) was used to measure trait mindfulness. The MAAS is one-dimensional and comprises 15 items measured on a 6-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 a single-factor construct and a Chronbach's value of 0.82 among a sample of university students [18]. 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 [18]. The Arabic MAAS has been shown to have excellent internal consistency and convergent validity among an Arab population [19].In our study, Chronbach's a.coefficient for the MAAS was 0.93. 

2.2.3.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 over-loaded)[20]. The scale comprises ten 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)[21]. The PSS has been validated for use among college students. The internal consistency coefficient for the PSS is 0.84 and the scale's test-retest reliability is 0.85 [21]. 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 [20]. The Chronbach's coefficient for the PSS was 0.82.

2.2.4.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 [22]. 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 [23]. The Arabic version of the ERQ has shown valid and reliable results among the Arab population [23].In our study, Chronbach's coefficient for the ERQ was 0.81.

2.2.5.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 [Phys-ical 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) [24]. 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 0-100, with higher scores reflecting better kidney disease quality of life [25]. The Arabic version used in this study showed good psychometric qualities among Arab patients with chronic renal failure [24].In our study, Chronbach's value for KDQOL-36 was 0.93.

2.3. Intervention 

2.3.1.Experimental group

The experimental group received Smith's version of mindfulness meditation [26], which is a standardized theory-based intervention found to be effective in improving stress and its related health problems. Smith's version of mindfulness meditation [26] 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, 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 min).

(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 min). (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 continue waiting (5 min).

(5)Being mindful of the 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 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 experimental group received 30-min individually administered, guided, chairside interventions during their hemodialysis sessions. This protocol has been found to 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-min sessions of the 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 [17]Accordingly, the experimental group received 30-min mindfulness meditation sessions three times a week for five weeks(450 min).

The participants also received a 2-h foundation course which was introduced and supervised privately by one of the study researchers prior to the actual training sessions in a room in the dialysis center 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. Two psychologists and experts validated the audio-recorded intervention contents in meditation. The recorded intervention instructions were accessed by the participants during the sessions using their cell phones and headsets, as recommended [17]. The intervention delivery using audio-recorded instructions allowed the researcher to introduce the individual intervention sessions for up to five participants simultaneously.

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., the machine beeps and interruptions)and evaluate the intervention delivery and compliance using checklists produced according to Smith's protocol [17]. The researcher completed the checklist after each session by asking the participants whether they completed all intervention protocols.

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 five weeks during hemodialysis sessions to control for the nonspecific effects of social interaction and environment [27]. 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 be asked to sit with their eyes closed and relax for 30 min also.

The participants' privacy and confidentiality were maintained where nobody was able to attend the data collection and intervention sessions. To avoid contamination bias, the participants in the experimental group were asked not to share any information related to the intervention with others during the study. Also, the nurses and physicians working in the hemodialysis centers were not given any detailed information about the intervention of the experimental group and would not pass any information about the intervention to the participants in the control group. At the end of the intervention, the participants in the control group confirmed that they had not practiced or received any information about mindfulness meditation during the study when they were asked about that by the researcher who supervised the intervention delivery.

2.4.Procedure

First, permission from the instruments used in the study was obtained. Recruitment of participants was conducted by one of the study researchers (Alshammari S.), who supervised the delivery of the intervention, after obtaining approval to conduct the study from the hospital administrators. The study's 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 baseline measurements(TO)of the study variables using the self-report questionnaires with a research assistant having a bachelor's nursing degree and 10 years of nephrology nursing experience. Another study researcher having a Ph.D. degree, who was not involved in the recruitment process and data collection, randomized the participants to the experimental group (n = 42) or the control group (n = 42), using a simple 1:1 computer-generated sequence. The study variables were measured two weeks post the start of the intervention (immediately after the sixth session, T1) and at the end of the final session(T2)for both groups. The measurements of the study variables at TO, T1, and T2 were conducted by the same research assistant who was not involved in any other parts of the study and was blinded to randomization allocation. 

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 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 < 0.05), 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 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.

2.6. 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. The study was registered on ClinicalTrial.gov (Identifier: NCT05176730).