NCT02673827

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 multiple-sclerosis

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_2 multiple-sclerosis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

January 28, 2016

Last Update Submit

February 1, 2016

Conditions

Multiple SclerosisDepressionSleepStress Psychological

Outcome Measures

Primary Outcomes (1)

  • Stress Level

    Instrument: Perceived Stress Scale.

    2 months

Secondary Outcomes (2)

  • Level of depression

    2 months

  • sleep quality

    2 months

Study Arms (2)

Group control

NO INTERVENTION

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

experimental group

EXPERIMENTAL

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

Interventions

Progressive muscle relaxationOTHER

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.

experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27598379DERIVED

MeSH Terms

Conditions

Multiple SclerosisDepressionStress, Psychological

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 4, 2016

Study Start

April 1, 2014

Primary Completion

October 1, 2014

Study Completion

July 1, 2015

Last Updated

February 4, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share