Clinical trial NCT04990661: The Effect of the Massage on Cramp Frequency, Cramp Severity, and Sleep Quality
Official title: The Effect of the Massage on Cramp Frequency, Cramp Severity, and Sleep Quality of Hemodialysis Patients With Complaint of Cramp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Cramps
Hemodialysis
Keywords: Hemodialysis
massage
muscle cramps
sleep quality
Lead sponsor: Kafkas University
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scala (VAS)
timeFrame: during 2 weeks (15 days)
measure: Muscle cramp assessment short survey (duration and frequency of muscle cramps)
timeFrame: during 2 weeks (15 days)
measure: Patient follow-up forms.
timeFrame: during 2 weeks (15 days)
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index(PUKİ),
timeFrame: At the first and last meeting in 2 weeks (15 days)
Other outcomes:
Locations:
city: Kars
country: Turkey
facility: Ayşe Gül Parlak
city: Kars
country: Turkey
facility: Kafkas University
Study officials:
affiliation: Kafkas Üniversity
name: ayşe gül parlak
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mastnardo D, Lewis JM, Hall K, Sullivan CM, Cain K, Theurer J, Huml A, Sehgal AR. Intradialytic Massage for Leg Cramps Among Hemodialysis Patients: a Pilot Randomized Controlled Trial. Int J Ther Massage Bodywork. 2016 Jun 3;9(2):3-8. doi: 10.3822/ijtmb.v9i2.305. eCollection 2016 Jun.
citation: Cox KJ, Parshall MB, Hernandez SHA, Parvez SZ, Unruh ML. Symptoms among patients receiving in-center hemodialysis: A qualitative study. Hemodial Int. 2017 Oct;21(4):524-533. doi: 10.1111/hdi.12521. Epub 2016 Dec 19.
citation: Flythe JE, Hilliard T, Lumby E, Castillo G, Orazi J, Abdel-Rahman EM, Pai AB, Rivara MB, St Peter WL, Weisbord SD, Wilkie CM, Mehrotra R; Kidney Health Initiative Prioritizing Symptoms of ESRD Patients for Developing Therapeutic Interventions Stakeholder Meeting Participants. Fostering Innovation in Symptom Management among Hemodialysis Patients: Paths Forward for Insomnia, Muscle Cramps, and Fatigue. Clin J Am Soc Nephrol. 2019 Jan 7;14(1):150-160. doi: 10.2215/CJN.07670618. Epub 2018 Nov 5.