Art Therapy to Treat Women With Fibromyalgia

April 25, 2012 updated by: Andréia S Baptista, PT, Federal University of São Paulo

Assessment of Art Therapy Program for Women With Fibromyalgia: Randomized, Controlled, Blinded Study

Effectiveness of an art therapy program for the treatment of pain and improvements in both quality of life and body image of patients with fibromyalgia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fibromyalgia (FM) is a chronic non-inflammatory syndrome characterized by diffuse pain throughout the body, sleep disorder, stiffness, fatigue, depression and other psychological problems. Patients with FM feel incapable of performing the majority of activities of daily living. Medication offers only short-term benefits. Thus, it is necessary to include other measures for treatment, such as physical activity and patient education. Art therapy combine the field of psychology with artistic activities, working with therapeutic and instructive aspects as well as the potential for personal growth contained in all forms of art.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 03237070
        • Andréia Salvador Baptista

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Classification of fibromyalgia by ACR criteria (Wolf et al, 1990)
  • Females
  • Without distinction of race
  • Age 18 to 65 years
  • Do not have changed treatment for fibromyalgia for at least 3meses
  • signing the consent form

Exclusion Criteria:

  • Other ostearticulares rheumatic and painful
  • Decompensated cardio-respiratory diseases
  • Perform physical activity more than 2x a week for more than 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Art Therapy
This group performed dance classes and regarding the art therapy they have art classes where they learn how to use the drawing to express feelings. The classes were twice a week.
Other: Art Therapy
This group performed dance classes and regarding the art therapy they have art classes where they learn how to use the drawing to express feelings. The classes were twice a week.
Other Names:
  • Rehabilitation, exercise, physical therapy
Experimental: Walking
The group walked twice a week during one hour.
Other: Walking
The group walked twice a week during one hour.
Other Names:
  • Rehabilitation, exercise, physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain
Time Frame: baseline, after 10 weeks, 20 weeks and 40 weeks
Evaluated with the visual analogue scale
baseline, after 10 weeks, 20 weeks and 40 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fibromyalgia impact
Time Frame: Baseline, after 10, 20 and 40 weeks
Evaluated using the Fibromyalgia Impact Questionnaire
Baseline, after 10, 20 and 40 weeks
Change in Quality of life
Time Frame: Baseline, after 10, 20 and 40 weeks
Evaluated using the SF-36 questionnaire
Baseline, after 10, 20 and 40 weeks
Change in Body image
Time Frame: Basline, after 10, 20 and 40 weeks
Evaluated using the Body Dismorphic Disorder Examination (BDDE) questionnaire
Basline, after 10, 20 and 40 weeks
Change in Functional capacity
Time Frame: Baseline, after 10, 20 and 40 weeks
Evaluated using the six minute walk test
Baseline, after 10, 20 and 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Andréia S Baptista, PT, MSc, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

April 25, 2012

First Posted (Estimate)

April 27, 2012

Study Record Updates

Last Update Posted (Estimate)

April 27, 2012

Last Update Submitted That Met QC Criteria

April 25, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0206/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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