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Art Therapy to Treat Women With Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andréia S Baptista, PT, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01586637
First received: February 16, 2012
Last updated: April 25, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
 Other: Art Therapy
Other: Walking
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Art Therapy Program for Women With Fibromyalgia: Randomized, Controlled, Blinded Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Change in Pain [ Time Frame: baseline, after 10 weeks, 20 weeks and 40 weeks ] [ Designated as safety issue: No ]
    Evaluated with the visual analogue scale


Secondary Outcome Measures:
  • Change in fibromyalgia impact [ Time Frame: Baseline, after 10, 20 and 40 weeks ] [ Designated as safety issue: No ]
    Evaluated using the Fibromyalgia Impact Questionnaire

  • Change in Quality of life [ Time Frame: Baseline, after 10, 20 and 40 weeks ] [ Designated as safety issue: No ]
    Evaluated using the SF-36 questionnaire

  • Change in Body image [ Time Frame: Basline, after 10, 20 and 40 weeks ] [ Designated as safety issue: No ]
    Evaluated using the Body Dismorphic Disorder Examination (BDDE) questionnaire

  • Change in Functional capacity [ Time Frame: Baseline, after 10, 20 and 40 weeks ] [ Designated as safety issue: No ]
    Evaluated using the six minute walk test


Enrollment: 80
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Rehabilitation, exercise, physical therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586637

Locations
Brazil
Andréia Salvador Baptista
São Paulo, Brazil, 03237070
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Andréia S Baptista, PT, MSc Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Andréia S Baptista, PT, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01586637     History of Changes
Other Study ID Numbers: 0206/10
Study First Received: February 16, 2012
Last Updated: April 25, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Fibromyalgia
Art Therapy
Pain
Quality of life
Body Image

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013