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Reflexology Versus Progressive Muscle Relaxation for Fatigue in Hemodialysis Patients (PMR-HD)

8. maj 2026 opdateret af: Farah Mohammed Mohammed Mohier, Cairo University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Egypten
    • Sharqia Governorate
      • Zagazig, Sharqia Governorate, Egypten, 44654
        • El Hussainiya Central Hospital - Nephrology Unit
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: styring
Andet: Control
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.
Eksperimentel: Zoneterapi
Adfærdsmæssigt: reflexology
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.
Eksperimentel: progressive muscle relaxation
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

31. august 2026

Studieafslutning (Anslået)

30. september 2026

Datoer for studieregistrering

Først indsendt

4. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P.T.REC/012/005983

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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