PMR vs MM for Patients on Hemodialysis
ConditionEnd Stage Renal Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJordan University of Science and Technology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with ESRD undergoing hemodialysis at least three sessions a week
being at least 18 years old
having a smartphone
being capable of reading and writing in Arabic
Disqualifiers
Patients under psychotherapy or taking regular psychopharmacological and analgesic treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness-based intervention
BehavioralThe 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
Behavioralhe 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.
Treatment groups
159 Participants
are divided into 3 treatment groupsGroup A: Patients with ESRD receiving mindfulness-based interventionExperimental treatment 1 intervention
Group B: Patients with ESRD receiving progressive muscle relaxationActive comparator 1 intervention
Group C: Patients with ESRD receiving the hospital traditional careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Perceived Stress Scale (PSS)
An 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, and overloaded) (Almadi, et al., 2012). It includes 10 items measured on a 5-point Likert scale (0=never, 4= very often), which are relatively free of content specific to any subpopulation group. The scores range from 0 to 40 with higher score indicating higher levels of perceived stress (stressful appraisal) (Cohen, et al., 1983). PSS has been validated for use with college students. Internal consistency coefficients for the PSS ranged from .84 to 36, and test- retest reliability is .85 (Cohen et al., 1983). The Arabic Perceived Stress Scale showed adequate reliability and validity and considered a suitable instrument to assess perceived stress in Arabic people (Almadi et al., 2012).
Time frame
From enrollment to the end of treatment at 8 weeks2
Emotion Regulation Questionnaire (ERQ)
An Arabic version of ERQ will be used to measure emotion regulation abilities including cognitive reappraisal and expression suppression. The questionnaire is a 7-point Likert-type scale, with two subscales including cognitive reappraisal (6 items) and expressive suppression (4 items). The scale items are rated on a scale from 1 (strongly disagree) to 7 (strongly agree). The higher scores indicate greater emotion regulation abilities such as cognitive reappraisal and expressive suppression (Gross \& John, 2003). Arabic version showed valid and reliable results among Arabic Gulf population and Jordanian patients with ESRD (Alhawatmeh et al. 2022; Keshky, 2018).
Time frame
From enrollment to the end of treatment at 8 weeksSecondary outcomes
1
The Mindful Attention Awareness Scale (MAAS)
The MAAS is a widely used self-report measure designed to assess an individual's trait mindfulness-their general capacity to be present and attentive to ongoing experiences in daily life. The MAAS typically consists of 15 items. Patients rate how frequently they experience various characteristics of mindfulness in day-to-day activities. Participants rate each item on a Likert-type scale. This scale indicates frequency of experiences from "1: almost always" to "5: almost never" (Brown \& Ryan, 2003). The total Score on the MAAS range from 15 to 75, with ahigher scores indicating higher levels of trait mindfulness. The scale has been applied extensively in clinical and scientific contexts. It investigates connections between many facets of mental health and wellbeing and mindfulness (Brown \& Ryan, 2003). Strong convergent validity and internal consistency are demonstrated by Arabic MAAS among Arab hemodialysis patients (Alhawatmeh et al., 2022).
Time frame
From enrollment to the end of treatment at 8 weeksSponsors and contacts
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Source ClinicalTrials.gov
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