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

NCT ID: NCT04833673

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-22
• Study Completion Date: 2021-03-15

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PMR: Progressive Muscle Relaxation

Intervention Type: BEHAVIORAL

tensing and relaxing the body muscles accompanied with deep breathing

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.

Group Type: EXPERIMENTAL

BRT:Benson Relaxation Technique

Intervention Type: BEHAVIORAL

relaxation using mental imagery and mediation

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PMR: Progressive Muscle Relaxation

tensing and relaxing the body muscles accompanied with deep breathing

Intervention Type: BEHAVIORAL

BRT:Benson Relaxation Technique

relaxation using mental imagery and mediation

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Gülşah Kesik

res.ass.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

gulsah kesik, MSc

Role: PRINCIPAL_INVESTIGATOR

research assisstant

Locations

Hacettepe University

Ankara, None Selected, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 35149625 (View on PubMed)

Other Identifiers

333

Identifier Type: -

Identifier Source: org_study_id