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

Primary Purpose

Muscular Cramps, Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
intradialytic massage
Sponsored by
Kafkas University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Muscular Cramps focused on measuring Hemodialysis, massage, muscle cramps, sleep quality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ayşe Gül Parlak
  • Kafkas University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group (massage group)

Control group

Arm Description

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

not administered except nursing interventions in the HD unit.

Outcomes

Primary Outcome Measures

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.
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.
Patient follow-up forms.
Intradialytic systolic and diastolic blood pressure and ultrafiltration were noted by the investigator, during the HD session

Secondary Outcome Measures

Pittsburgh Sleep Quality Index(PUKİ),
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.

Full Information

First Posted
July 2, 2021
Last Updated
July 27, 2021
Sponsor
Kafkas University
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1. Study Identification

Unique Protocol Identification Number
NCT04990661
Brief Title
The Effect of the Massage on Cramp Frequency, Cramp Severity, and Sleep Quality
Acronym
Massage
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafkas University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Cramps, Hemodialysis
Keywords
Hemodialysis, massage, muscle cramps, sleep quality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group (massage group)
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
not administered except nursing interventions in the HD unit.
Intervention Type
Behavioral
Intervention Name(s)
intradialytic massage
Intervention Description
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 Outcome Measure Information:
Title
Visual Analog Scala (VAS)
Description
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.
Time Frame
during 2 weeks (15 days)
Title
Muscle cramp assessment short survey (duration and frequency of muscle cramps)
Description
Participants noted the duration and number of muscle cramps they experienced. Baseline measurements; muscle cramp experienced at home and, during the dialysis session.
Time Frame
during 2 weeks (15 days)
Title
Patient follow-up forms.
Description
Intradialytic systolic and diastolic blood pressure and ultrafiltration were noted by the investigator, during the HD session
Time Frame
during 2 weeks (15 days)
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index(PUKİ),
Description
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.
Time Frame
At the first and last meeting in 2 weeks (15 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ayşe gül parlak
Organizational Affiliation
Kafkas Üniversity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayşe Gül Parlak
City
Kars
ZIP/Postal Code
36000
Country
Turkey
Facility Name
Kafkas University
City
Kars
ZIP/Postal Code
36000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27257445
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.
Results Reference
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PubMed Identifier
27990732
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.
Results Reference
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PubMed Identifier
30397026
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.
Results Reference
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The Effect of the Massage on Cramp Frequency, Cramp Severity, and Sleep Quality

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