Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
74 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-01-01
Study Completion Date
2021-06-30
Brief Summary
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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.
Method: An experimental repeated measures design was used among a sample of 74 end-stage renal disease patients undergoing hemodialysis at a 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-minute mindfulness meditation sessions (three sessions a week for five weeks) held during their hemodialysis sessions. The dependent variables of both groups were measured at baseline, middle of intervention, and end of intervention using the Mindful Attention Awareness Scale (MAAS), Perceived Stress Scale (PSS), Emotion Regulation Questionnaire (ERQ), and Kidney Disease Quality of Life (KDQOL-36) questionnaire.
Method: An experimental repeated measures design was used among a sample of 74 end-stage renal disease patients undergoing hemodialysis at a 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-minute mindfulness meditation sessions (three sessions a week for five weeks) held during their hemodialysis sessions. The dependent variables of both groups were measured at baseline, middle of intervention, and end of intervention using the Mindful Attention Awareness Scale (MAAS), Perceived Stress Scale (PSS), Emotion Regulation Questionnaire (ERQ), and Kidney Disease Quality of Life (KDQOL-36) questionnaire.
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Detailed Description
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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. However, compliance with treatment has been found to be poor among ESRD patients. 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. 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.
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. 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. 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.
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. 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. It is claimed that repeated mindfulness-based practices cultivate and improve the natural mental capacity of mindfulness, called trait mindfulness. Trait mindfulness is described as the mental capacity to pay attention to, be aware of, and accept current experiences in a non-judgmental way. 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.
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. For patients undergoing hemodialysis specifically, studies have demonstrated that mindfulness meditation significantly improves trait mindfulness, stress symptoms, emotion regulation, and quality of life and general health. However, these studies have serious limitations that limit the validity and generalizability of their findings. For example, these studies generally used small samples, in addition to inconsistent intervention protocols in terms of the intervention contents and duration. Further, no study has examined the effectiveness of mindfulness-based interventions among patients undergoing hemodialysis in Kuwait. Therefore, 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.
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 hospitals.
Methods
Design
This study used a repeated-measures, randomized, wait-list, control design and was conducted 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.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. Taking into consideration a 60% attrition rate, the final total sample size was 89 patients.
Intervention
The experimental group received the Smith's version of mindfulness meditation, 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 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 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 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. 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 intervention 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. 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.
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. 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 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), 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.
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. However, compliance with treatment has been found to be poor among ESRD patients. 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. 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.
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. 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. 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.
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. 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. It is claimed that repeated mindfulness-based practices cultivate and improve the natural mental capacity of mindfulness, called trait mindfulness. Trait mindfulness is described as the mental capacity to pay attention to, be aware of, and accept current experiences in a non-judgmental way. 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.
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. For patients undergoing hemodialysis specifically, studies have demonstrated that mindfulness meditation significantly improves trait mindfulness, stress symptoms, emotion regulation, and quality of life and general health. However, these studies have serious limitations that limit the validity and generalizability of their findings. For example, these studies generally used small samples, in addition to inconsistent intervention protocols in terms of the intervention contents and duration. Further, no study has examined the effectiveness of mindfulness-based interventions among patients undergoing hemodialysis in Kuwait. Therefore, 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.
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 hospitals.
Methods
Design
This study used a repeated-measures, randomized, wait-list, control design and was conducted 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.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. Taking into consideration a 60% attrition rate, the final total sample size was 89 patients.
Intervention
The experimental group received the Smith's version of mindfulness meditation, 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 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 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 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. 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 intervention 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. 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.
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. 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 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), 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.
Conditions
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Chronic Kidney Diseases
Hemodialysis Complication
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
A repeated-measure, two-group, randomized design
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
SINGLE
Outcome Assessors
The data were collected by three research assistants with at least 10 years nursing experiences who were not involved in any other parts of the study.
Also, the participants were randomly assigned equally to the study groups using a computerized random numbers procedure carried out by a research assistant who was not involved in any other parts of the study
Also, the participants were randomly assigned equally to the study groups using a computerized random numbers procedure carried out by a research assistant who was not involved in any other parts of the study
Study Groups
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Patients with hemodialysis receiving mindfulness meditation
The ABC standardized version of mindfulness meditation was used. The experimental group received 30-minute mindfulness meditation sessions 3 times a week for 5 weeks (450 minutes). An additional two-hour educational workshop about the rationale and procedures of intervention was provided before the actual training sessions. To ensure the consistent delivery of the intervention, the researcher recorded the intervention instructions in Arabic based on the intervention protocol and sent the audio-recorded instructions to the participants via WhatsApp or email. The audio-recorded intervention contents were validated by two 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. This method allowed for up to 3-5 participants to listen to the instructions and perform the intervention simultaneously.
Group Type
EXPERIMENTAL
Mindfulness meditation
Intervention Type
BEHAVIORAL
Similar to the information included in arm/group descriptions
Control group
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. 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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Mindfulness meditation
Similar to the information included in arm/group descriptions
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* being a patient with ESRD undergoing hemodialysis three times a week
* being aged 18 years old or over
* being able to read and write in Arabic.
* being aged 18 years old or over
* being able to read and write in Arabic.
Exclusion Criteria
* being a patient with cognitive dysfunction or mental retardation
* taking psychopharmacological drugs
* undergoing psychotherapy
* practicing any type of relaxation techniques
* taking psychopharmacological drugs
* undergoing psychotherapy
* practicing any type of relaxation techniques
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Jordan University of Science and Technology
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Hossam Alhawatmeh, PhD
Role: PRINCIPAL_INVESTIGATOR
Jordan University of Science and Technology
Locations
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Jordan University of Science and Technology
Irbid, None Selected, Jordan
Site Status
Countries
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Jordan
References
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Tohme F, Mor MK, Pena-Polanco J, Green JA, Fine MJ, Palevsky PM, Weisbord SD. Predictors and outcomes of non-adherence in patients receiving maintenance hemodialysis. Int Urol Nephrol. 2017 Aug;49(8):1471-1479. doi: 10.1007/s11255-017-1600-4. Epub 2017 Apr 28.
Reference Type
BACKGROUND
Kraus MA, Fluck RJ, Weinhandl ED, Kansal S, Copland M, Komenda P, Finkelstein FO. Intensive Hemodialysis and Health-Related Quality of Life. Am J Kidney Dis. 2016 Nov;68(5S1):S33-S42. doi: 10.1053/j.ajkd.2016.05.023.
Reference Type
BACKGROUND
Shariaty Z, Mahmoodi Shan GR, Farajollahi M, Amerian M, Behnam Pour N. The effects of probiotic supplement on hemoglobin in chronic renal failure patients under hemodialysis: A randomized clinical trial. J Res Med Sci. 2017 Jun 21;22:74. doi: 10.4103/jrms.JRMS_614_16. eCollection 2017.
Reference Type
BACKGROUND
Haramaki Y, Kabir RS, Abe K, Yoshitake T. Promoting Self-Regulatory Management of Chronic Pain Through Dohsa-hou: Single-Case Series of Low-Functioning Hemodialysis Patients. Front Psychol. 2019 Jun 20;10:1394. doi: 10.3389/fpsyg.2019.01394. eCollection 2019.
Reference Type
BACKGROUND
Thomas Z, Novak M, Platas SGT, Gautier M, Holgin AP, Fox R, Segal M, Looper KJ, Lipman M, Selchen S, Mucsi I, Herrmann N, Rej S. Brief Mindfulness Meditation for Depression and Anxiety Symptoms in Patients Undergoing Hemodialysis: A Pilot Feasibility Study. Clin J Am Soc Nephrol. 2017 Dec 7;12(12):2008-2015. doi: 10.2215/CJN.03900417. Epub 2017 Oct 12.
Reference Type
BACKGROUND
Zhang D, Lee EKP, Mak ECW, Ho CY, Wong SYS. Mindfulness-based interventions: an overall review. Br Med Bull. 2021 Jun 10;138(1):41-57. doi: 10.1093/bmb/ldab005.
Reference Type
BACKGROUND
Garland E, Gaylord S, Park J. The role of mindfulness in positive reappraisal. Explore (NY). 2009 Jan-Feb;5(1):37-44. doi: 10.1016/j.explore.2008.10.001.
Reference Type
BACKGROUND
Cho IH, Suh SR, Jang KH. Stress coping resources of hemodialysis patients: Mindfulness. International Journal of Advanced Nursing Education and Research. 2017;2(1):153-8
Reference Type
BACKGROUND
Kabat-Zinn, Mindfulness-based interventions in context: past, present, and future, Clin. Psychol. Sci. Pract 2003;10(2):144-156
Reference Type
BACKGROUND
Igarashi NS, Karam CH, Afonso RF, Carneiro FD, Lacerda SS, Santos BF, Kozasa EH, Rangel EB. The effects of a short-term meditation-based mindfulness protocol in patients receiving hemodialysis. Psychol Health Med. 2022 Jul;27(6):1286-1295. doi: 10.1080/13548506.2021.1871769. Epub 2021 Jan 15.
Reference Type
BACKGROUND
Adamoli AN, Razzera BN, Ranheiri MF, Colferai RN, Russell TA, Noto AR, et al. Mindfulness-Based Intervention Performed During Hemodialysis: an Experience Report. Trends in Psychology 2021;29(2):320-40
Reference Type
BACKGROUND
Gross CR, Reilly-Spong M, Park T, Zhao R, Gurvich OV, Ibrahim HN. Telephone-adapted Mindfulness-based Stress Reduction (tMBSR) for patients awaiting kidney transplantation. Contemp Clin Trials. 2017 Jun;57:37-43. doi: 10.1016/j.cct.2017.03.014. Epub 2017 Mar 22.
Reference Type
BACKGROUND
Noorifard M, Neshat Doost H T, Sajjadian I. Comparative of Mindfulness with Memory Specificity Training (MEST) on Cognitive Emotion Regulation Strategies in Hemodialysis Patients. MEJDS 2019; 9:46-46
Reference Type
BACKGROUND
Moosavi Nejad M, Shahgholian N, Samouei R. The effect of mindfulness program on general health of patients undergoing hemodialysis. J Educ Health Promot. 2018 Jun 12;7:74. doi: 10.4103/jehp.jehp_132_17. eCollection 2018.
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DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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731-2020
Identifier Type: -
Identifier Source: org_study_id
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