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Completed

NCT Number: NCT04990661

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

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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Key information

Conditions

Muscular Cramps Dyssomnias Hemodialysis Mental Disorders Muscle Cramp Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ayşe Gül Parlak, Kars, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intradialytic massage

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kafkas University

Other

Registry information

Official study title

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

Acronym: Massage

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Aug 4, 2021
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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