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The goal of this clinical trial is to compare the effects of reflexology and progressive muscle relaxation in reducing fatigue among hemodialysis patients and to determine which intervention provides greater relief from fatigue.
The main question it aims to answer is:
Is there any difference in effectiveness between reflexology and progressive muscle relaxation techniques in reducing fatigue levels among patients undergoing hemodialysis?
Participants will be randomly assigned to one of three groups:
Group 1: 20 participants will receive reflexology therapy 3 times per week for 12 weeks.
Group 2: 20 participants will receive progressive muscle relaxation 3 times per week for 12 weeks.
Group 3: 20 participants will be a control group.
Fatigue and sleep quality will be measured before and after the intervention using:
Fatigue Severity Scale (FSS) Pittsburgh Sleep Quality Index (PSQI) Epworth Sleepiness Scale (ESS)
This study aims to offer a safe, low-cost, non-pharmacological method that can help hemodialysis patients reduce fatigue and improve sleep quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reflexology | Experimental |
| |
| progressive muscle relaxation | Experimental |
| |
| control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reflexology | Behavioral | This group will receive reflexology on feet; each session lasts 20 minutes. Participants will receive reflexology therapy 3 times per week for 12 weeks. In addition, they will continue taking their prescribed medications and follow standard nutritional guidelines recommended for patients with chronic kidney disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Fatigue Severity Scale (FSS) at 12 weeks | The Fatigue Severity Scale is a 9-item questionnaire used to assess the severity of fatigue and its impact on daily functioning. The total score ranges from 1 to 7, with higher scores indicating greater fatigue severity and worse outcomes. | Baseline and after 12 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at 12 weeks | The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire used to assess sleep quality. It includes 19 items organized into 7 components, which generate a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality. | Baseline and after 12 weeks of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Farah M. selim | Contact | +201018707210 | farahsalleem1@gmail.com | |
| Hania Muhammad selim | Contact | +201018694969 | hania.mohier@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El Hussainiya Central Hospital - Nephrology Unit | Zagazig | Sharqia Governorate | 44654 | Egypt |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D005221 | Fatigue |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D001326 | Autogenic Training |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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|
| progressive muscle relaxation | Behavioral | This group will perform progressive muscle relaxation for 10 minutes per session, 3 times per week for 12 weeks. In addition, they will continue taking their prescribed medications and follow standard nutritional guidelines recommended for patients with chronic kidney disease. |
|
| Control | Other | The participants will be observed for 12 weeks while continuing taking their prescribed medications and following standard nutritional guidelines recommended for patients with chronic kidney disease. |
|
| Change from baseline in Epworth Sleepiness Scale (ESS) at 12 weeks | The Epworth Sleepiness Scale (ESS) is an 8-item questionnaire used to assess daytime sleepiness. Scores range from 0 to 24, with higher scores indicating greater daytime sleepiness and worse outcomes. | Baseline and after 12 weeks of intervention |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D006990 |
| Hypnosis |
| D026441 | Mind-Body Therapies |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |