Progressive Muscle Relaxation Effect on Sleep Quality, Depression and Stress in People With Multiple Sclerosis

NCT ID: NCT02673827

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-07-31

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.

Conditions

Multiple Sclerosis; Depression; Sleep; Stress Psychological

Study Design

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

Study Groups

Group control

Control group: 20 patients with relapsing-remitting multiple sclerosis only receive traditional treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

experimental group

Intervention group: 20 patients with relapsing-remitting multiple sclerosis receive five sessions of Progressive Muscle Relaxation under the supervision of a researcher in neurology clinic. Before and after each session of the Progressive Muscle Relaxation.

They will be measured heart rate, respiratory rate and blood pressure. Participants will be guided to realize the Progressive Muscle Relaxation daily for 8 weeks, the time of day you feel more comfortable. the same receive education and training as the technical as well as a audio and a leaflet with the description the stages of the Progressive Muscle Relaxation.

Group Type: EXPERIMENTAL

Progressive muscle relaxation

Intervention Type: OTHER

Intervention group: 20 patients with relapsing-remitting multiple sclerosis receive five sessions of Progressive Muscle Relaxation under the supervision of a researcher in neurology clinic. Before and after each session of the Progressive Muscle Relaxation They will be measured heart rate, respiratory rate and blood pressure. Participants will be guided to realize the Progressive Muscle Relaxation daily for 8 weeks, the time of day you feel more comfortable. the same receive education and training as the technical as well as a audio and a leaflet with the description the stages of the Progressive Muscle Relaxation. Control group: 20 patients with relapsing-remitting multiple sclerosis only receive traditional treatment.

Interventions

Progressive muscle relaxation

Intervention group: 20 patients with relapsing-remitting multiple sclerosis receive five sessions of Progressive Muscle Relaxation under the supervision of a researcher in neurology clinic. Before and after each session of the Progressive Muscle Relaxation They will be measured heart rate, respiratory rate and blood pressure. Participants will be guided to realize the Progressive Muscle Relaxation daily for 8 weeks, the time of day you feel more comfortable. the same receive education and training as the technical as well as a audio and a leaflet with the description the stages of the Progressive Muscle Relaxation. Control group: 20 patients with relapsing-remitting multiple sclerosis only receive traditional treatment.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Espirito Santo

OTHER

Sponsor Role: lead

Responsible Party

Paolla Gabrielle Nascimento Novais

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 27598379 (View on PubMed)

Other Identifiers

618.841/2014

Identifier Type: -

Identifier Source: org_study_id