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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04833673
Recruitment Status : Completed
First Posted : April 6, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Gülşah Kesik, Hacettepe University

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Pain, Chronic Fatigue Syndrome, Chronic Kinesiophobia Behavioral: PMR: Progressive Muscle Relaxation Behavioral: BRT:Benson Relaxation Technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Three Arms Randomized Trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of Relaxation Techniques on Pain, Fatigue and Kinesiophobia in Multiple Sclerosis Patients: A Three Arms Randomized Trial
Actual Study Start Date : June 22, 2020
Actual Primary Completion Date : December 30, 2020
Actual Study Completion Date : March 15, 2021


Arm Intervention/treatment
Experimental: PMR

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.

Behavioral: PMR: Progressive Muscle Relaxation
tensing and relaxing the body muscles accompanied with deep breathing

Experimental: BRT
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.
Behavioral: BRT:Benson Relaxation Technique
relaxation using mental imagery and mediation

No Intervention: CG
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.



Primary Outcome Measures :
  1. Fatigue [ Time Frame: 12 weeks ]
    Fatigue Severity Scale


Secondary Outcome Measures :
  1. Chronic Pain [ Time Frame: 12 weeks ]
    VAS

  2. Kinesiophobia [ Time Frame: 12 weeks ]
    Tampa Scale for Kinesophobia



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04833673


Locations
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Turkey
Hacettepe University
Ankara, None Selected, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: gulsah kesik, MSc research assisstant
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gülşah Kesik, res.ass., Hacettepe University
ClinicalTrials.gov Identifier: NCT04833673    
Other Study ID Numbers: 333
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Private and personal information of the participants is not open to sharing.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gülşah Kesik, Hacettepe University:
multiple sclerosis
pain
fatigue
kinesiophobia
relaxation techniques
muscle relaxation
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Fatigue Syndrome, Chronic
Fatigue
Chronic Pain
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pain
Neurologic Manifestations
Virus Diseases
Infections
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Neuromuscular Diseases