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

K

Kafkas University

Status

Completed

Conditions

Hemodialysis
Muscular Cramps

Treatments

Behavioral: intradialytic massage

Study type

Interventional

Funder types

Other

Identifiers

NCT04990661
Kafkas Unıversity

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 2 patient groups

Intervention group (massage group)
Experimental group
Description:
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
Treatment:
Behavioral: intradialytic massage
Control group
No Intervention group
Description:
not administered except nursing interventions in the HD unit.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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