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

Depression Clinical Trial

Official title:

Effect of Progressive Muscle Relaxation as a Nursing Intervention on Sleep Quality, Depression and Stress in People With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673827
• Other study ID #: 618.841/2014
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2016
• Last updated: February 1, 2016
• Start date: April 2014
• Est. completion date: July 2015

Study information

• Verified date: February 2016
• Source: Federal University of Espirito Santo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Multiple Sclerosis
• Sclerosis
• Sleep
• Stress Psychological

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Espirito Santo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress Level	Instrument: Perceived Stress Scale.	2 months	No
Secondary	Level of depression	Instrument : Beck Depression Inventory.	2 months	No
Secondary	sleep quality	Instrument: Pittsburgh Sleep Quality Index.	2 months	No