NCT06604403

Brief Summary

This study was conducted to determine the effect of massage on comfort and fatigue levels of hemodialysis patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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

May 10, 2022

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.5 years

First QC Date

September 17, 2024

Last Update Submit

September 17, 2024

Conditions

Keywords

MassageHemodialysis PatientsNursingComfortFatigue

Outcome Measures

Primary Outcomes (2)

  • Hemodialysis Comfort Scale

    The scale developed by Sahin Orak and his colleagues in 2017 consists of nine items and two sub-dimensions. These sub-dimensions are; "Relaxation" (7-9) and "Overcoming" (1- 6). The scale is a five-point Likert type (1: never -5: always). Items 1-3 and 5-9 of the scale are reverse coded. The lowest score that can be obtained from the scale is 9, the highest score is 45. The higher the score, the higher the comfort level.

    Up to 4 weeks

  • Piper Fatigue Scale

    The scale was developed by Barbara F. Piper and her friends in 1987 and adapted to Turkish by Can and her friends in 2001. The scale consists of 22 items and four sub-dimensions. These are; "Behavior/Violence" (2-7); "Affect" (8-12), "Sensory" (5 items; 13-17) and "Cognitive/Psychological" (18-23). In addition to this, there are five items (1 and 24-27) that are not used in calculating the fatigue score, but are recommended to remain in the scale because they are important in evaluating data related to fatigue. The scale is evaluated using a 0-10 Vizuel Analog Scale. The total score obtained from the scale is divided by the number of items. The minimum score that can be obtained from the scale is 0, and the maximum score is 10. The higher the score, the more fatigue the individual feels.

    Up to 4 weeks

Study Arms (2)

Massage Group

EXPERIMENTAL

Patients in the intervention group will receive post-hemodialysis massage twice a week for four weeks.

Other: Massage

Control Group

NO INTERVENTION

Routine nursing care was given to the patients in this group without any message.

Interventions

MassageOTHER

After the hemodialysis, the patients will receive a 15-20 minute hand and foot massage. This application will be applied to the patients in two weekly dialysis sessions for a total of 8 sessions for four weeks. Before starting the massage applications, the patient's hands and feet will be washed and dried thoroughly. The patients will be given a semi-sitting or lying position that they can feel comfortable in. Before starting the hand and foot massage, the researcher will gently rub and warm their hands and wrists. The massages will start with a hand massage. A foot massage will be performed after the hand massage. 3-5 drops of baby oil applied at room temperature will be used to reduce friction during the massage. Effleurage, petrissage and friction styles of the massage will be applied.

Massage Group

Eligibility Criteria

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

You may qualify if:

  • Volunteering to participate in the study
  • Being 18 years of age or older
  • Receiving hemodialysis treatment in a dialysis unit for at least six months
  • Not having a condition that prevents verbal communication
  • Not having a psychiatric problem

You may not qualify if:

  • Patients who left the study at any stage
  • Patients who had been receiving hemodialysis treatment for less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fatigue

Interventions

Massage

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Zeynep YILDIRIM, Res. Ass.

CONTACT

Mağfiret KAŞIKÇI, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 19, 2024

Study Start

May 10, 2022

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations