Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04990661
Acronym
Massage
Enrollment
36
Registered
2021-08-04
Start date
2020-08-01
Completion date
2021-06-21
Last updated
2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis, Muscular Cramps

Keywords

Hemodialysis, massage, muscle cramps, sleep quality

Brief summary

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.

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.

Interventions

BEHAVIORALintradialytic 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

Sponsors

Kafkas University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scala (VAS)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.
Muscle cramp assessment short survey (duration and frequency of muscle cramps)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.
Patient follow-up forms.during 2 weeks (15 days)Intradialytic systolic and diastolic blood pressure and ultrafiltration were noted by the investigator, during the HD session

Secondary

MeasureTime frameDescription
Pittsburgh Sleep Quality Index(PUKİ),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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026