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

Hemodialysis Clinical Trial

— Massage  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04990661
• Other study ID #: Kafkas University
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: June 21, 2021

Study information

• Verified date: July 2021
• Source: Kafkas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 21, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis
• Muscle Cramp
• Spasm

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Turkey	Ayse Gül Parlak	Kars
Turkey	Kafkas University	Kars

Sponsors (1)

Lead Sponsor	Collaborator
Kafkas University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. eCollection 2016 Jun. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scala (VAS)	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.	during 2 weeks (15 days)
Primary	Muscle cramp assessment short survey (duration and frequency of muscle cramps)	Participants noted the duration and number of muscle cramps they experienced. Baseline measurements; muscle cramp experienced at home and, during the dialysis session.	during 2 weeks (15 days)
Primary	Patient follow-up forms.	Intradialytic systolic and diastolic blood pressure and ultrafiltration were noted by the investigator, during the HD session	during 2 weeks (15 days)
Secondary	Pittsburgh Sleep Quality Index(PUKI),	Pittsburgh Sleep Quality Index (PUKI) used to evaluate sleep quality.The total score is between 0-21. PUKI score of 5 or above indicates poor sleep quality.	At the first and last meeting in 2 weeks (15 days)