The Effect of Progressive Muscle Relaxation Exercises on Depression and Fatigue in Patients Receiving Hemodialysis Treatment: A Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorIstanbul Aydın University

About this trial

This study aims to evaluate the effects of progressive muscle relaxation exercises on depression and fatigue levels in patients undergoing hemodialysis treatment. Progressive muscle relaxation is applied as an individualized non-pharmacological intervention, and its potential contribution to psychological well-being is investigated. The study seeks to determine whether regular relaxation exercises can reduce depressive symptoms, alleviate fatigue, and improve overall emotional well-being in hemodialysis patients. Findings from this research are expected to provide evidence for the use of relaxation-based interventions as supportive care methods in the management of psychological symptoms associated with chronic kidney disease and hemodialysis.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Progressive Muscle Relaxation Intervention

    Behavioral

    The study population consisted of all patients receiving treatment at the center during the study period. Instead of a statistical sample size calculation, a total population sampling method was used. All voluntary patients who met the inclusion criteria and were receiving hemodialysis at the center during the specified time frame were included. Among patients who scored 4 or above on the First-Level Beck Depression Inventory, an independent nurse not involved in the research team assigned unique codes. A computer-generated random number table was then used to allocate participants into the intervention group (30 patients) and control group (30 patients) in a 1:1 ratio.Progressive muscle relaxation exercises were used as the relaxation technique. Participants were instructed to assume a comfortable position, and all instructions were delivered clearly and understandably. The exercise program was planned for 8 weeks, 3 days per week, for 30 minutes per session. The first session was con

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

First-Level Beck Depression Screening Inventory (BDÖ-BB):

The Turkish validity and reliability study was conducted by Aktürk et al. (2005). The scale includes seven subdimensions: sadness, pessimism, past failures, self-dislike, self-blame, loss of interest, and suicidal thoughts or desires. Patients evaluate their experiences over the past two weeks. Each item includes four response options scored between 0 and 3. The maximum total score is 21, and higher scores indicate greater depressive symptoms. Scores above 4 suggest a depression probability of over 90%. This cutoff was used in the present study. Cronbach's alpha, Spearman-Brown, and Guttman Split-Half coefficients were reported as 0.85, 0.86, and 0.82, respectively.

Time frame
12 week

Secondary outcomes

1

Piper Fatigue Scale (PFS):

Developed by Piper et al. (1998), this 22-item scale includes four subdimensions: behavioral/severity, affective meaning, sensory, and cognitive/mood. Items are scored between 1 (mild) and 10 (severe), and higher scores indicate higher perceived fatigue. The Turkish validity and reliability study by Can (2004) reported a Cronbach's alpha of 0.94

Time frame
12 week

Other outcomes

1

Progressive Muscle Relaxation Intervention

Progressive muscle relaxation exercises were used as the relaxation technique. Participants were instructed to assume a comfortable position, and all instructions were delivered clearly and understandably. The exercise program was planned for 8 weeks, 3 days per week, for 30 minutes per session. The first session was conducted face-to-face by the researchers, after which instructional videos were shared through a WhatsApp group created for participants. Reminders were provided before each session.

Time frame
12 week

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