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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673827
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Paolla Gabrielle Nascimento Novais, Federal University of Espirito Santo

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Depression Sleep Stress Psychological Other: Progressive muscle relaxation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Progressive Muscle Relaxation as a Nursing Intervention on Sleep Quality, Depression and Stress in People With Multiple Sclerosis
Study Start Date : April 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Group control
Control group: 20 patients with relapsing-remitting multiple sclerosis only receive traditional treatment.
Experimental: 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.

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.




Primary Outcome Measures :
  1. Stress Level [ Time Frame: 2 months ]
    Instrument: Perceived Stress Scale.


Secondary Outcome Measures :
  1. Level of depression [ Time Frame: 2 months ]
    Instrument : Beck Depression Inventory.

  2. sleep quality [ Time Frame: 2 months ]
    Instrument: Pittsburgh Sleep Quality Index.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paolla Gabrielle Nascimento Novais, Principal investigator, Federal University of Espirito Santo
ClinicalTrials.gov Identifier: NCT02673827    
Other Study ID Numbers: 618.841/2014
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases