PMR vs MM for Patients on Hemodialysis

NCT06625125 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2024-10-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Progressive muscle relaxation

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.

Sponsors & Collaborators

  • Jordan University of Science and Technology

    lead OTHER

Principal Investigators

  • Hossam Alhawatmeh · Hossam alhawatmeh, assistant professor, Jordan university of science and technology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2024-12-31
Completion
2025-01-31

Countries

  • Jordan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06625125 on ClinicalTrials.gov