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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-06-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Muscular Cramps Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

intradialytic massage

Intervention Type BEHAVIORAL

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

Control group

not administered except nursing interventions in the HD unit.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No