- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07575607
Reflexology Versus Progressive Muscle Relaxation for Fatigue in Hemodialysis Patients (PMR-HD)
Comparative Efficacy of Reflexology and Progressive Muscle Relaxation in Mitigating Fatigue Among Hemodialysis Patients
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Farah M. selim
- Telefonnummer: +201018707210
- E-post: farahsalleem1@gmail.com
Studer Kontakt Backup
- Navn: Hania Muhammad selim
- Telefonnummer: +201018694969
- E-post: hania.mohier@gmail.com
Studiesteder
-
-
Sharqia Governorate
-
Zagazig, Sharqia Governorate, Egypt, 44654
- El Hussainiya Central Hospital - Nephrology Unit
-
Ta kontakt med:
- selim
- Telefonnummer: +201018707210
- E-post: farahselim199@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: kontroll
|
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.
|
|
Eksperimentell: Refleksologi
|
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.
|
|
Eksperimentell: progressive 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in Fatigue Severity Scale (FSS) at 12 weeks
Tidsramme: 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.
|
Baseline and after 12 weeks of intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at 12 weeks
Tidsramme: 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.
|
Baseline and after 12 weeks of intervention
|
|
Change from baseline in Epworth Sleepiness Scale (ESS) at 12 weeks
Tidsramme: 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.
|
Baseline and after 12 weeks of intervention
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Sykdommer i nervesystemet
- Psykiske lidelser
- Patologiske prosesser
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Kronisk sykdom
- Sykdomsattributter
- Søvnvåkenforstyrrelser
- Nyreinsuffisiens
- Søvnforstyrrelser, iboende
- Dyssomnier
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Utmattelse
- Søvninitiering og vedlikeholdsforstyrrelser
- Nyresvikt, kronisk
- Nyresvikt, kronisk
- Terapeutikk
- Mind-kroppsbehandlinger
- Komplementære terapier
- Fysioterapi -modaliteter
- Psykoterapi
- Atferdsdisipliner og aktiviteter
- Rehabilitering
- Hypnose
- Muskel- og skjelettmanipulasjoner
- Autogen trening
Andre studie-ID-numre
- P.T.REC/012/005983
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