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Art Therapy to Treat Women With Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01586637
First Posted: April 27, 2012
Last Update Posted: April 27, 2012
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.
Information provided by (Responsible Party):
Andréia S Baptista, PT, Federal University of São Paulo
  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 (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:


Further study details as provided by Andréia S Baptista, PT, Federal University of São Paulo:

Primary Outcome Measures:
  • Change in Pain [ Time Frame: baseline, after 10 weeks, 20 weeks and 40 weeks ]
    Evaluated with the visual analogue scale


Secondary Outcome Measures:
  • Change in fibromyalgia impact [ Time Frame: Baseline, after 10, 20 and 40 weeks ]
    Evaluated using the Fibromyalgia Impact Questionnaire

  • Change in Quality of life [ Time Frame: Baseline, after 10, 20 and 40 weeks ]
    Evaluated using the SF-36 questionnaire

  • Change in Body image [ Time Frame: Basline, after 10, 20 and 40 weeks ]
    Evaluated using the Body Dismorphic Disorder Examination (BDDE) questionnaire

  • Change in Functional capacity [ Time Frame: Baseline, after 10, 20 and 40 weeks ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 16, 2012
First Posted: April 27, 2012
Last Update Posted: April 27, 2012
Last Verified: April 2012

Keywords provided by Andréia S Baptista, PT, 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