PMR vs MM for Patients on Hemodialysis

Sponsor
Jordan University of Science and Technology
Study ID
NCT06625125
Status
Not Yet Recruiting

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Conditions

  • End Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mindfulness-based intervention — BEHAVIORAL
    The mindful mediators are asked to act as neutral observers who quietly attend to, notice, and let go of internal and external stimuli (present experiences) such as thoughts, feelings, physical sensations, and sounds without reactions, evaluation, and judgments. (Smith, 2005). The subjects in the mindfulness-based intervention (MBI) group will receive 30 minutes individually administered, guided, chairside interventions during their hemodialysis sessions, three times a week over eight weeks (Alhawatmeh et al., 2022; Thomas et al., 2017). Subjects in this group will receive their assigned intervention developed by the principal investigator (PI) according to the Smith's MBI protocol that will provide intervention instructions. During the eight weeks and at bedtime at night, the subjects will be optionally encouraged to practice the intervention at home.
  • Progressive muscle relaxation — BEHAVIORAL
    he progressive muscle relaxation (PMR) group will receive the ABC version of PMR (Smith, 2005). This abbreviated version of PMR involves a tense-let go exercise of 11 muscle groups including hand, arm, arm and sides, back, shoulder, face, front of neck, stomach, chest, leg, and foot. As the MBI group, the subjects in the PMR group will receive 30 minutes individually administered, guided, chairside interventions during their hemodialysis sessions, three times a week over eight weeks. Subjects in this group will receive their assigned intervention developed by the principal investigator (PI) according to the Smith's PMR protocol that will provide intervention instructions. During the eight weeks and at bedtime at night, the subjects will be optionally encouraged to practice the intervention at home.

Study Details

Background: Hemodialysis is considered as an effective therapy to remove harmful waste from the body and to improve the quality of life in patients suffering from end-stage renal disease (ESRD). However, patients who receive hemodialysis perceive various stressors that are harmful to their physical and psychological well-being. Therefore, it is necessary to implement effective and practical therapeutic strategies to enhance the quality of life in this population. Mindfulness-based intervention (MBI) and progressive muscle relaxation (PMR) are effective mind-body connection programs that are inadequately used in patients undergoing hemodialysis. Objectives: This study will examine the differential effects of mindfulness-based intervention (MBI) and progressive muscle relaxation (PMR) on expression suppression, cognitive reappraisal, and perceived Stress in Patients with End-Stage Renal Disease undergoing hemodialysis in Jordan. Methods: An experimental parallel control, randomized design will be implemented among 159 PwESRD undergoing hemodialysis in a big referral Hospital in Jordan. Simple random assignation will be used to create three equal groups including PMR, MBI, and control groups (N= each). Both groups will practice their assigned intervention over five weeks (with three half-hour sessions per week) during hemodialysis sessions. The study variables will be measured for the three groups at the outset and eight weeks after initiation. Variables will be measured by the self-reporting questionnaire including sociodemographic characteristic sheet, the Mindfulness attention awareness scale (MAAS) the Perceived Stress Scale (PSS), and the Emotion Regulation Questionnaire (ERQ). Repeated measures analysis of variance (RM ANOVA) will be used to analyze the main study data.

Key Dates

First listed
Oct 3, 2024
Start date
Oct 31, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2024
Completion
Jan 31, 2025

Study Design

Enrollment
159 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Patients with ESRD receiving mindfulness-based intervention
    The mindful mediators are asked to act as neutral observers who quietly attend to, notice, and let go of internal and external stimuli (present experiences) such as thoughts, feelings, physical sensations, and sounds without reactions, evaluation, and judgments. (Smith, 2005). The subjects in the mindfulness-based intervention (MBI) group will receive 30 minutes individually administered, guided, chairside interventions during their hemodialysis sessions, three times a week over eight weeks (Alhawatmeh et al., 2022; Thomas et al., 2017). Subjects in this group will receive their assigned intervention developed by the principal investigator (PI) according to the Smith's MBI protocol that will provide intervention instructions. During the eight weeks and at bedtime at night, the subjects will be optionally encouraged to practice the intervention at home.
  • Active Comparator: Patients with ESRD receiving progressive muscle relaxation
    The progressive muscle relaxation (PMR) group will receive the ABC version of PMR (Smith, 2005). This abbreviated version of PMR involves a tense-let go exercise of 11 muscle groups including hand, arm, arm and sides, back, shoulder, face, front of neck, stomach, chest, leg, and foot. As the MBI group, the subjects in the PMR group will receive 30 minutes individually administered, guided, chairside interventions during their hemodialysis sessions, three times a week over eight weeks. Subjects in this group will receive their assigned intervention developed by the principal investigator (PI) according to the Smith's PMR protocol that will provide intervention instructions. During the eight weeks and at bedtime at night, the subjects will be optionally encouraged to practice the intervention at home.
  • No Intervention: Patients with ESRD receiving the hospital traditional care
    The control group will not receive any intervention from the study researchers

Primary Outcome Measure

Perceived Stress Scale (PSS) [ Time Frame: From enrollment to the end of treatment at 8 weeks ]

Central Contacts

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