Mindfulness Meditation For Hemodialysis Patients

NCT05176730 | Completed

• 1 other identifier: 731-2020
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Diseases; Hemodialysis Complication

Keywords

Hemodialysis; Stress; Emotion regulation; Mindfulness meditation; Quality of life; Chronic kidney disease

Outcome Measures

Primary Outcomes (4)

• Trait Mindfulness

  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 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 Arabic MAAS has been shown to have excellent internal consistency and convergent validity among an Arab population. In our study, the Chronbach's alpha values for the MAAS was 0.93.

  6 weeks

• 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). 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 Arabic PSS has been shown to have adequate reliability and validity and is considered a suitable instrument for assessing perceived stress in Arab people \[21\]. In the current study, the Chronbach's alpha values for the PSS was 0.82.

  6 weeks

• Emotion regulation

  The Arabic version of the Emotion Regulation Questionnaire (ERQ) was used to assess emotion regulation among the study sample. 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. The Arabic version of the ERQ has shown valid and reliable results among the Arab population. In our study, the Chronbach's alpha values for the ERQ was 0.81.

  6 weeks

• 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). 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. The Arabic version used in this study showed good psychometric qualities among Arab patients with chronic renal failure. In our study, the Chronbach's alpha values for KDQOL-36 was 0.93.

  6 weeks

Study Arms (2)

Patients with hemodialysis receiving mindfulness meditation

EXPERIMENTAL

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.

Behavioral: Mindfulness meditation

Control group

NO INTERVENTION

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.

Interventions

Mindfulness meditation BEHAVIORAL

Similar to the information included in arm/group descriptions

Patients with hemodialysis receiving mindfulness meditation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• being a patient with cognitive dysfunction or mental retardation
• taking psychopharmacological drugs
• undergoing psychotherapy
• practicing any type of relaxation techniques

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Jordan University of Science and Technology

Irbid, None Selected, 22110, Jordan

Location

Related Publications (27)

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  BACKGROUND

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  PMID: 35509694 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Emotional Regulation

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hossam Alhawatmeh, PhD

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A repeated-measure, two-group, randomized design

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: January 1, 2021
• Primary Completion: May 15, 2021
• Study Completion: June 30, 2021
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)