Clinical trial NCT04833673: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Pain, Chronic
Fatigue Syndrome, Chronic
Kinesiophobia
Keywords: multiple sclerosis
pain
fatigue
kinesiophobia
relaxation techniques
muscle relaxation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Three Arms Randomized Trial
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Fatigue
timeFrame: 12 weeks
Secondary outcomes:
measure: Chronic Pain
timeFrame: 12 weeks
measure: Kinesiophobia
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: None Selected
Study officials:
affiliation: research assisstant
name: gulsah kesik, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.