NCT06416384

Brief Summary

This study aims to examine the effect of hand massage on patients receiving HD treatment on the severity of post-dialysis fatigue and post-dialysis recovery time.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

29 days

First QC Date

May 10, 2024

Last Update Submit

August 6, 2024

Conditions

Keywords

hemodialysis patientfatiquehand massagenursingrecovery time

Outcome Measures

Primary Outcomes (2)

  • fatigue severity

    Fatigue severity was evaluated before starting the application (pre-test) Post-Dialysis Fatigue Scale: Kodama et al. The "Post-Dialysis Fatigue Scale" developed by (2020) is a five-item likert type scale consisting of 13 items. The scale is used to evaluate the severity of fatigue by examining the factors associated with fatigue observed after the end of treatment in dialysis patients. According to Özen et al. (2021) the total number of items in the scale after Turkish validity and reliability made by is 11.

    one week= first session

  • recovery time

    Recovery time after dialysis was evaluated before starting the application (pre-test)

    One week= first session

Secondary Outcomes (2)

  • fatique severity

    After 4 weeks

  • recovery time after dialysis

    After 4 weeks

Study Arms (2)

Hand Massage Group

EXPERIMENTAL

The researcher applied a hand massage to the hand area of the patients in the experimental group on the side without fistula for five minutes, three times a week for four weeks.

Other: Control Group

Control Group

OTHER

Patients in the control group received routine nursing care in the clinic for four weeks.

Other: Hand Massage Group

Interventions

The patients in the hand massage application group were asked by the researcher; Hand massage with olive oil was applied 12 times in total, three times a week for four weeks. No application was made to the side with fistula.

Also known as: Experimental
Control Group

Patients in the control group received routine nursing care in the clinic for four weeks.

Also known as: Control
Hand Massage Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those who are 18 years or older,
  • Receiving hemodialysis treatment for at least 3 months,
  • Receiving hemodialysis treatment three times a week,
  • Does not have any open wounds in the area to be applied,
  • No active fistula in the arm to be treated,
  • Does not have a hearing impairment,
  • Sufficient to understand the questions,
  • Open to communication and cooperation,
  • Volunteer and willing for research

You may not qualify if:

  • Having an active oncological problem or receiving oncological treatment,
  • Those with health problems that require contact isolation,
  • The number of dialysis sessions changed during the study,
  • Those who lost their lives while working,
  • Those who had a kidney transplant during the study,
  • Those who want to leave voluntarily at any stage of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University İnstitute of Health Sciences

Amasya, Merkez, 05100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Eylem Topbaş, Phd

    Amasya University

    STUDY DIRECTOR
  • Seyit Ahmet KORKMAZ

    Amasya University health sciences institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single-blind (outcomes assessor)
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: It is a randomized controlled, single-blind, experimental study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2024

First Posted

May 16, 2024

Study Start

January 9, 2024

Primary Completion

February 7, 2024

Study Completion

November 7, 2024

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

It can only be shared after publication upon special request from the authors.

Locations