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The Effects of Relaxation Techniques on Pain, Fatigue and Kinesiophobia in Multiple Sclerosis Patients: A Three Arms Randomized Trial

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting, Pain, Chronic, Fatigue Syndrome, Chronic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PMR: Progressive Muscle Relaxation
BRT:Benson Relaxation Technique
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring multiple sclerosis, pain, fatigue, kinesiophobia, relaxation techniques, muscle relaxation

Eligibility Criteria

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

Inclusion Criteria:

  • over the age of 18
  • having relapsing-remitting MS type and not had an attack during the study
  • not receiving any other complementary and integrative therapy during the research,
  • with an Expanded Disability Status Scale score of 5.5 and below,
  • volunteer to participate in study

Exclusion Criteria:

  • having physical or mental health problems that can interfere with communication
  • having heart failure, COPD, asthma disease, renal failure, musculoskeletal problem such as fracture, plaster cast, amputation, fibromyalgia, ankylosing spondylitis, rheumatoid arthritis, deep anemia (hmg <8 mg / dl) or oncological diagnoses
  • not having undergone any surgical operation in the last 3 months

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

PMR

BRT

CG

Arm Description

The PMR intervention involving tensing and relaxing the body muscles accompanied with deep breathing. The researchers told each participant to sit in a soundless and breathable room and in a comfortable position before each session at their home. The participants performed tensing and relaxing for each body part in order, starting with the facial muscles and head, followed by neck, shoulders, chest, abdomen, legs, and feet; all muscle tension and relaxation procedures were performed with deep breathing. The participants were instructed to tense a specified group of muscles for 5 s and relax it for 10 s while breathing out. Moreover, throughout this exercise, the participants imagined a wave of relaxation flowing over their body.

Within the scope of this technique, first of all, the participants were asked to focus on a word that relieves them such as love, health or well-being. And so, the participants were asked to be in comfortable position in a silent and breathable room with the closed eyes, relax their muscles from the sole of their feet and progressing up to their face gradually, keep them relaxed, accompanied with deep breathing, be aware of their breathing, exhale gently. They continue these practices for 20 minutes and try to relax their muscles. After finishing the duration, they sit quietly for several minutes with eyes closed and later with eye opened.

Regarding CG, the participants were invited to the same room and received only a single time attention-matched education on "Living with MS"; including definition of MS, dietary advices for MS patients. The attention-matched education was performed face to face and lasted for 10 min. All participants in the three study groups also received usual treatment and care.

Outcomes

Primary Outcome Measures

Fatigue
Fatigue Severity Scale

Secondary Outcome Measures

Chronic Pain
VAS
Kinesiophobia
Tampa Scale for Kinesophobia

Full Information

First Posted
April 5, 2021
Last Updated
April 5, 2021
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04833673
Brief Title
The Effects of Relaxation Techniques on Pain, Fatigue and Kinesiophobia in Multiple Sclerosis Patients: A Three Arms Randomized Trial
Official Title
The Effects of Relaxation Techniques on Pain, Fatigue and Kinesiophobia in Multiple Sclerosis Patients: A Three Arms Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
March 15, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Even though, current treatments including IVIG, corticosteroids, biological agents can provide positive effects on MS symptoms, MS cannot be cured completely today. Therefore, in addition to the available medical treatment options, patients may tend towards complementary and integrative therapies. Relaxation techniques are one of the non-pharmacological and side-effect-free therapy options that are currently used to alleviate the symptoms of many different chronic diseases. Progressive muscle relaxation exercise (PMR) and Benson relaxation technique (BRT) are two common types of relaxation techniques recommended for symptom management in chronic diseases owing to simple to learn and apply compared to other complementary and integrative methods for patients. PMR is uncomplicated and low-cost method, originally designed by Jacobson (1938), which helps individuals to feel calmer through consecutive muscle tension and relaxation of a muscle group. This method can relieve muscle tension, facilitate sleep, and reduce severity of pain and fatigue. There are studies in the literature reporting the positive effects of PMR on fatigue, sleep quality, quality of life, anxiety and stress in MS patients. One of these techniques which is well tolerated is BRT, designed by Herbert Benson in the 1970s as a nonpharmacologic and behavioral method. This technique led to relaxation using mental imagery and mediation. BRT creates a relaxation influence in the body by decreasing the sympathetic nervous system activity and increasing the parasympathetic nervous system activity. There are few studies in the literature reporting that BRT is beneficial on pain and fatigue in MS patients.To the best of our knowledge, there is no study on the impact of relaxation techniques on pain, fatigue and kinesophobia in MS patients. The aim of this study was to examine and compare the effects of PMR and BRT on abovementioned symptoms in MS patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting, Pain, Chronic, Fatigue Syndrome, Chronic, Kinesiophobia
Keywords
multiple sclerosis, pain, fatigue, kinesiophobia, relaxation techniques, muscle relaxation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Three Arms Randomized Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PMR
Arm Type
Experimental
Arm Description
The PMR intervention involving tensing and relaxing the body muscles accompanied with deep breathing. The researchers told each participant to sit in a soundless and breathable room and in a comfortable position before each session at their home. The participants performed tensing and relaxing for each body part in order, starting with the facial muscles and head, followed by neck, shoulders, chest, abdomen, legs, and feet; all muscle tension and relaxation procedures were performed with deep breathing. The participants were instructed to tense a specified group of muscles for 5 s and relax it for 10 s while breathing out. Moreover, throughout this exercise, the participants imagined a wave of relaxation flowing over their body.
Arm Title
BRT
Arm Type
Experimental
Arm Description
Within the scope of this technique, first of all, the participants were asked to focus on a word that relieves them such as love, health or well-being. And so, the participants were asked to be in comfortable position in a silent and breathable room with the closed eyes, relax their muscles from the sole of their feet and progressing up to their face gradually, keep them relaxed, accompanied with deep breathing, be aware of their breathing, exhale gently. They continue these practices for 20 minutes and try to relax their muscles. After finishing the duration, they sit quietly for several minutes with eyes closed and later with eye opened.
Arm Title
CG
Arm Type
No Intervention
Arm Description
Regarding CG, the participants were invited to the same room and received only a single time attention-matched education on "Living with MS"; including definition of MS, dietary advices for MS patients. The attention-matched education was performed face to face and lasted for 10 min. All participants in the three study groups also received usual treatment and care.
Intervention Type
Behavioral
Intervention Name(s)
PMR: Progressive Muscle Relaxation
Intervention Description
tensing and relaxing the body muscles accompanied with deep breathing
Intervention Type
Behavioral
Intervention Name(s)
BRT:Benson Relaxation Technique
Intervention Description
relaxation using mental imagery and mediation
Primary Outcome Measure Information:
Title
Fatigue
Description
Fatigue Severity Scale
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Chronic Pain
Description
VAS
Time Frame
12 weeks
Title
Kinesiophobia
Description
Tampa Scale for Kinesophobia
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: over the age of 18 having relapsing-remitting MS type and not had an attack during the study not receiving any other complementary and integrative therapy during the research, with an Expanded Disability Status Scale score of 5.5 and below, volunteer to participate in study Exclusion Criteria: having physical or mental health problems that can interfere with communication having heart failure, COPD, asthma disease, renal failure, musculoskeletal problem such as fracture, plaster cast, amputation, fibromyalgia, ankylosing spondylitis, rheumatoid arthritis, deep anemia (hmg <8 mg / dl) or oncological diagnoses not having undergone any surgical operation in the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
gulsah kesik, MSc
Organizational Affiliation
research assisstant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
State/Province
None Selected
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Private and personal information of the participants is not open to sharing.
Citations:
PubMed Identifier
35149625
Citation
Kesik G, Ozdemir L, Mungan Ozturk S. The Effects of Relaxation Techniques on Pain, Fatigue, and Kinesiophobia in Multiple Sclerosis Patients: A 3-Arm Randomized Trial. J Neurosci Nurs. 2022 Apr 1;54(2):86-91. doi: 10.1097/JNN.0000000000000620.
Results Reference
derived

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The Effects of Relaxation Techniques on Pain, Fatigue and Kinesiophobia in Multiple Sclerosis Patients: A Three Arms Randomized Trial

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