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

NCT04990661 | Completed DMC

• 1 other identifier: Kafkas Unıversity
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Muscular Cramps; Hemodialysis

Keywords

Hemodialysis; massage; muscle cramps; sleep quality

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (1)

• Pittsburgh Sleep Quality Index(PUKİ),

  At the first and last meeting in 2 weeks (15 days)

Study Arms (2)

Intervention group (massage group)

EXPERIMENTAL

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

Behavioral: intradialytic massage

Control group

NO INTERVENTION

not administered except nursing interventions in the HD unit.

Interventions

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

Intervention group (massage group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafkas University: lead

Study Sites (2)

Ayşe Gül Parlak

Kars, 36000, Turkey (Türkiye)

Location

Kafkas University

Kars, 36000, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 27257445 BACKGROUND

• 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.

  PMID: 27990732 BACKGROUND

• 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.

  PMID: 30397026 BACKGROUND

MeSH Terms

Conditions

Muscle Cramp; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• ayşe gül parlak

  Kafkas Üniversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: August 4, 2021
• Study Start: August 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: June 21, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)