End Stage Renal Failure, Hemodialysis, Fatigue
Conditions
Keywords
Reflexology, Relaxation, Fatigue, Sleep quality, Non-pharmacological interventions, Hemodialysis, End-stage renal failure, Progressive muscle relaxation, Fatigue Severity Scale, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Chronic kidney disease
Brief summary
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.
Interventions
BEHAVIORALreflexology
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.
BEHAVIORALprogressive muscle relaxation
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.
OTHERControl
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients of both genders aged from 50 to 70 years old. * Patients are experiencing moderate to severe fatigue (as measured by a standardized fatigue scale). * Medically stable as determined by the attending nephrologist. * Able to understand and follow instructions for relaxation techniques
Exclusion criteria
* Patients with severe cognitive impairment or psychiatric disorders that interfere with participation. * Patients with foot ulcers, wounds, or any contraindications for foot reflexology. * Currently practicing any relaxation or complementary therapies regularly. * Patients with unstable medical conditions or undergoing treatment changes during the study period. * History of recent surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Fatigue Severity Scale (FSS) at 12 weeks | Baseline and after 12 weeks of intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at 12 weeks | Baseline and after 12 weeks of intervention | 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. |
| Change from baseline in Epworth Sleepiness Scale (ESS) at 12 weeks | Baseline and after 12 weeks of intervention | 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. |
Countries
Egypt
Contacts
CONTACTFarah M. selim
CONTACTHania Muhammad selim
Outcome results
None listed