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

Primary Purpose

Multiple Sclerosis, Depression, Sleep

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Progressive muscle relaxation
Sponsored by
Federal University of Espirito Santo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Group control

    experimental group

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    Stress Level
    Instrument: Perceived Stress Scale.

    Secondary Outcome Measures

    Level of depression
    Instrument : Beck Depression Inventory.
    sleep quality
    Instrument: Pittsburgh Sleep Quality Index.

    Full Information

    First Posted
    January 28, 2016
    Last Updated
    February 1, 2016
    Sponsor
    Federal University of Espirito Santo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02673827
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Espirito Santo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis, Depression, Sleep, Stress Psychological

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group control
    Arm Type
    No Intervention
    Arm Description
    Control group: 20 patients with relapsing-remitting multiple sclerosis only receive traditional treatment.
    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Progressive muscle relaxation
    Intervention Description
    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 Measure Information:
    Title
    Stress Level
    Description
    Instrument: Perceived Stress Scale.
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    Level of depression
    Description
    Instrument : Beck Depression Inventory.
    Time Frame
    2 months
    Title
    sleep quality
    Description
    Instrument: Pittsburgh Sleep Quality Index.
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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)

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27598379
    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.
    Results Reference
    derived

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

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