- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07512895
The Effect of Progressive Muscle Relaxation Exercises on Depression and Fatigue in Patients Receiving Hemodialysis Treatment: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hemodialysis is a vital treatment modality for patients with kidney failure, extending life expectancy and reducing associated symptoms. However, it also introduces significant physical, psychological, and social challenges for patients. Fatigue, one of the most frequently reported symptoms among hemodialysis patients, substantially impairs daily functioning and quality of life, with studies indicating that 42% to 89% of these individuals experience clinically relevant fatigue levels.
In addition to physical symptoms, anxiety and depression are common psychological problems among hemodialysis patients. These symptoms are closely linked to fatigue and sleep disturbances. Depression often presents with persistent fatigue and low energy, whereas insomnia can contribute to the onset or exacerbation of fatigue, anxiety, and depressive symptoms. Globally, approximately 280 million people are affected by depression, with significant prevalence among adults and older adults. Depression is a major contributor to disability worldwide and is projected to become the leading cause of disease burden by 2030. In a study involving 55,982 patients with chronic kidney disease, nearly one-quarter were found to experience depression, with even higher rates reported among those receiving maintenance hemodialysis. Current evidence indicates that the prevalence of depression in this population ranges from 20% to 47%.
Progressive Muscle Relaxation (PMR), first introduced by Jacobson in 1924, is a technique aimed at achieving physical and mental relaxation through systematic tensing and releasing of muscle groups. Research has shown that relaxation practices reduce oxygen consumption, heart rate, respiratory rate, and muscle tension while alleviating pain perception and lowering stress responses through increased endorphin production. Ortega et al. (2021) highlighted that PMR enhances awareness of bodily sensations and reduces tension, while Ramaiah and Albokhary (2021) demonstrated that progressive relaxation and similar home-based practices significantly decreased menstrual pain severity through increased blood flow and suppression of sympathetic nervous system activity. These findings suggest that PMR can serve as an effective complementary approach for both physical and psychological symptoms.
The present study aims to evaluate the effects of progressive muscle relaxation exercises on depression and fatigue levels in patients undergoing hemodialysis. Specifically, it investigates whether this individualized intervention contributes to improved psychological well-being among hemodialysis patients.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arzu Kavala, Assistant Prof
- Phone Number: +905445418208
- Email: arzukavala@aydin.edu.tr
Study Locations
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Istanbul, Turkey (Türkiye)
- Recruiting
- Arzu Kavala
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Contact:
- Arzu Kavala
- Phone Number: +905445418208
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Istanbul
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Istanbul, Istanbul, Turkey (Türkiye)
- Recruiting
- Istanbul Aydın Universty
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Contact:
- Arzu Kavala, Assistant Prof
- Phone Number: +905445418208
- Email: arzukavala@aydin.edu.tr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Scoring 4 or above on the First-Level Beck Depression Inventory
Patients who regularly receive hemodialysis treatment
Individuals who are cognitively capable of understanding the exercise instructions
Individuals who voluntarily agree to participate in the study and provide informed consent
Exclusion Criteria:
Individuals diagnosed with a psychiatric disorder (e.g., major depression, bipolar disorder, schizophrenia, etc.)
Individuals who are physically unable to perform relaxation exercises due to musculoskeletal disorders
Individuals who have previously participated regularly in relaxation therapy, yoga, meditation, or similar practices
Individuals who cannot follow instructions due to hearing, visual, or cognitive impairments
Individuals who are simultaneously participating in another psychosocial or physical intervention program
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Group
Progressive muscle relaxation exercise will be applied to the experimental group.
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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
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No Intervention: Control Group
No Interventıon
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First-Level Beck Depression Screening Inventory (BDÖ-BB):
Time Frame: 12 week
|
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.
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12 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Piper Fatigue Scale (PFS):
Time Frame: 12 week
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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
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12 week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progressive Muscle Relaxation Intervention
Time Frame: 12 week
|
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.
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12 week
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARZU KAVALA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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