Clinical trial NCT02673827: Progressive Muscle Relaxation Effect on Sleep Quality, Depression and Stress in People With Multiple Sclerosis
Official title: Effect of Progressive Muscle Relaxation as a Nursing Intervention on Sleep Quality, Depression and Stress in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Depression
Sleep
Stress Psychological
Lead sponsor: Federal University of Espirito Santo
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: Evaluate the effects of Progressive Muscle Relaxation on sleep quality and on stress and depression levels of individuals with multiple sclerosis.

Detailed description: Introduction: Multiple sclerosis is a chronic, autoimmune disease, characterized by demyelination and neurodegeneration of the central nervous system. The progressive course of this disease may cause individuals to develop extreme dependency and create serious difficulties both to the individuals themselves and family members and caregivers, since the disease brings a number of physical, emotional, psychological and social symptoms. Therefore, it is essential to offer healthcare practices that go beyond the usually fragmenting, dehumanized care services that focus on the disease bodily processes.

Objective: Evaluate the effects of Progressive Muscle Relaxation on sleep quality and on stress and depression levels of individuals with multiple sclerosis.

Methodology: This is randomized clinical test. The sample was made up of 40 individuals with multiple sclerosis (20 in control group and 20 in the experimental group) in outpatient follow-up. The progressive muscle relaxation technique was employed. In order to collect the data, we adopted the interview with form filling technique, using the Pittsburgh Sleep Quality Index, Perceived Stress Scale and Beck Depression Inventory. Blood pressure, heart rate and respiratory rate of experimental group were measured before and after the progressive muscle relaxation intervention. In order to treat statistical data, we used Statistical Package for Social Sciences, version 19.0.

Eligibility criteria: Inclusion Criteria:

* To be diagnosed with Multiple Sclerosis for at least 6 months
* To be diagnosed with relapsing-remitting multiple sclerosis
* To have Expanded Disability Status Scale score \< 5.0
* To not have had any attacks during the 3-month period preceding enrollment in the study
* To have audio at home
* To be residing in the Metropolitan region of Vitória-Espirito Santo-Brazil.
* To be 18-65 years of age
* Treatment with an immunomodulator

Exclusion Criteria:

* Being hospitalized at the time of data collection or outbreak at the time of data collection
* Have physical and / or mental changes that prevent the collection of data, such as motor or cognitive deficits
* Experiencing relapse and/or corticosteroid use within the last month, diagnosed with progressive MS (primary or secondary)
* Use of psychotropic drugs (antidepressants, benzodiazepines, antipsychotic and cannabis, or other stimulants),
* Practice of other relaxation techniques (yoga, pilates, meditation, psychotherapy)

Primary outcomes:
measure: Stress Level
timeFrame: 2 months
Secondary outcomes:
measure: Level of depression
timeFrame: 2 months
measure: sleep quality
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
citation: Novais PG, Batista Kde M, Grazziano Eda S, Amorim MH. The effects of progressive muscular relaxation as a nursing procedure used for those who suffer from stress due to multiple sclerosis. Rev Lat Am Enfermagem. 2016 Sep 1;24:e2789. doi: 10.1590/1518-8345.1257.2789.