The Effect of the Massage on Cramp Frequency, Cramp Severity, and Sleep Quality (Massage)

July 27, 2021 updated by: Ayse Gul Parlak, Kafkas University

The Effect of the Massage on Cramp Frequency, Cramp Severity, and Sleep Quality of Hemodialysis Patients With Complaint of Cramp

The aim of this randomized controlled experimental study was to determine the effect of the massage applied to hemodialysis patients with complaint of cramp on the cramp frequency, cramp severity, and sleep quality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was conducted with patients receiving treatment in a total of four hemodialysis units. The sample of the study comprised a total of 36 patients (18 patients in the intervention group and 18 patients in the control group) with complaint of cramp. In the study, intradialytic massage for lower extremity was applied to the intervention group in three sessions a week and a total of six sessions for two weeks. No intervention other than routine care was applied to the control group patients.

In the study, the data were collected using a patient information form, cramp assessment short survey, the "Visual Analog Scale (VAS)", "Pittsburgh Sleep Quality Index" (PUKİ), and patient follow-up forms.

In order to conduct the study, the necessary Ethics Committee approval and institutional permission were obtained. The individuals included in the study informed about the purpose of the research, their verbal consent obtained and the participant's informed consent form signed.

After the intervention and control groups were assigned according to the research criteria, the days and sessions of the groups were determined and recorded in the digital randomization environment.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kars, Turkey, 36000
        • Ayşe Gül Parlak
      • Kars, Turkey, 36000
        • Kafkas Üniversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years,
  • One or more lower work cramp attacks during/after dialysis
  • Have a constant dryness in the last 1 month (few changes weighing more than 2 kg)
  • Receiving at least 6 hemodialysis treatments
  • Receiving hemodialysis treatment 3 times a week
  • Those who have not received sub-massage therapy before

Exclusion Criteria:

  • Having one of the diagnoses of chronic obstructive pulmonary disease, cancer, psychiatric disease
  • Presence of any soft tissue, nerve and vascular disease in the lower extremities
  • Presence of infection, open wound, suspected fracture, dermatitis, burn and edema in the lower extremities
  • Having had a lower extremity operation in the past six weeks
  • Receiving hemodialysis treatment for less than 6 months (new patients are excluded because the first few months of dialysis treatment are periods of hemodynamic instability)
  • Having a fluctuating dry weight (excluded from the study as it may cause cramping)
  • Having been diagnosed with neuropathy in the lower extremities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group (massage group)
intradialytic massage for lower extremity was applied to the intervention group in three sessions a week and a total of six sessions for two weeks
Behavioral: intradialytic massage
intradialytic massage for lower extremity ( the massage included both feet and legs up to and including the knee) applied to the intervention group in three sessions a week and a total of six sessions for two weeks
No Intervention: Control group
not administered except nursing interventions in the HD unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scala (VAS)
Time Frame: during 2 weeks (15 days)
This scale; There is a number value of "0 (no pain)" at the beginning and "10 (the most unbearable pain)" at the end. Participants marked the scale each time they experience a muscle cramp severity. Baseline measurements; muscle cramp experienced at home and, during the dialysis session.
during 2 weeks (15 days)
Muscle cramp assessment short survey (duration and frequency of muscle cramps)
Time Frame: during 2 weeks (15 days)
Participants noted the duration and number of muscle cramps they experienced. Baseline measurements; muscle cramp experienced at home and, during the dialysis session.
during 2 weeks (15 days)
Patient follow-up forms.
Time Frame: during 2 weeks (15 days)
Intradialytic systolic and diastolic blood pressure and ultrafiltration were noted by the investigator, during the HD session
during 2 weeks (15 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index(PUKİ),
Time Frame: At the first and last meeting in 2 weeks (15 days)
Pittsburgh Sleep Quality Index (PUKI) used to evaluate sleep quality.The total score is between 0-21. PUKİ score of 5 or above indicates poor sleep quality.
At the first and last meeting in 2 weeks (15 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafkas University

Investigators

  • Principal Investigator: ayşe gül parlak, Kafkas Üniversity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

June 21, 2021

Study Registration Dates

First Submitted

July 2, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kafkas Unıversity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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