NCT04139759

Brief Summary

Hemodialysis patients face many problems related to disease and treatment, fatigue is stated as the most common of these problems. Therefore, The aim of this study is to examine the effect of hand massage and foot massage on fatigue in hemodialysis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 19, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

1 month

First QC Date

October 23, 2019

Last Update Submit

October 24, 2019

Conditions

Hemodialysis Patients

Keywords

NursingHemodialysisFatigueHand massageFoot massage

Outcome Measures

Primary Outcomes (1)

  • Pre-Hemodialysis / 1st Measurement

    In addition to verbal and written information, the first measurements were obtained by applying the Patient Presentation Form, Visual Similarity Scale for Fatigue to the patients who were taken to hand massage, foot massage and control groups before HD treatment. In 1990, Lee et al. developed the Visual Similarity Scale for Fatigue, consisting of 18 items, to determine fatigue. The items 1, 2, 3, 4, 5, 11, 12, 13, 14, 15, 16, 17, 18 of the scale included fatigue subcomponent and 6, 7, 8, 9,10 items belong to the energy subcomponent. The Visual Similarity Scale for Fatigue consists of 10 cm lines, the most positive expression at one end and the negative expression at the other end of the line. The high score of the fatigue subcomponent, the low score of the energy subcomponent, shows that the severity of fatigue is high.

    first day

Secondary Outcomes (1)

  • 2 Weeks Later /2nd Measurement

    fifteenth day

Other Outcomes (1)

  • 4 Weeks Later/ 3rd Measurement

    thirtieth day

Study Arms (3)

hand massage group

EXPERIMENTAL

In the hand massage group (n = 28), hand massage was applied to the hand without fistula for 8 minutes, 3 times a week, for 4 weeks.

Other: hand massage

Foot massages group

EXPERIMENTAL

Foot massages were applied to both feet of the patients in the foot massage group (n = 28), 3 times a week, for 4 weeks and patting and kneading movements were repeated 3-4 times.

Other: foot massage

control group

NO INTERVENTION

The patients in the control group (n = 28) were not administered except nursing interventions in the HD unit.

Interventions

hand massageOTHER

In the hand massage group (n = 28), hand massage was applied to the hand without fistula for 8 minutes, 3 times a week, for 4 weeks.

hand massage group
foot massageOTHER

Foot massages were applied to both feet of the patients in the foot massage group (n = 28), 3 times a week, for 4 weeks and patting and kneading movements were repeated 3-4 times.

Foot massages group

Eligibility Criteria

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

You may qualify if:

  • \- Taking HD therapy, in the dialysis unit of a public hospital in Turkey, between October 19, 2018 - February 11, 2019,
  • Agree to participate in the study with a written permission,
  • Over the age of 18,
  • Open to communication with complete orientation,
  • Speaks and understands Turkish
  • Receiving HD treatment 3 times a week for 6 months and longer,
  • No loss of sensation, mass, fracture or ingrown toenail (onyxis),
  • In the lower extremities; without pathological and tumoral disease, phlesis, embolism and no bleeding disorder related to amputation, fracture, infection, wound, skin disease, muscle and bones,
  • Patients with a Standardized Mini Mental Test (SMMT) score of 24 or more, in patients older than 65 years,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Batman Regional State Hospital

Batman, 72000, Turkey (Türkiye)

Location

Related Publications (2)

  • Astroth KS, Russell CL, Welch JL. Non-pharmaceutical fatigue interventions in adults receiving hemodialysis: a systematic review. Nephrol Nurs J. 2013 Sep-Oct;40(5):407-27; quiz 428.

    PMID: 24308108BACKGROUND

  • Ahmadidarrehsima S, Mohammadpourhodki R, Ebrahimi H, Keramati M, Dianatinasab M. Effect of foot reflexology and slow stroke back massage on the severity of fatigue in patients undergoing hemodialysis: A semi-experimental study. J Complement Integr Med. 2018 Sep 28;15(4). doi: 10.1515/jcim-2017-0183.

    PMID: 30265652RESULT

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 25, 2019

Study Start

October 19, 2018

Primary Completion

November 20, 2018

Study Completion

February 11, 2019

Last Updated

October 28, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

de-identified individual participate data for all primary and secondary outcome measures will be made available

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU(1)