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Completed

NCT Number: NCT01586637

Art Therapy to Treat Women With Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Andréia Salvador Baptista

São Paulo, 03237070, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Art therapy

Other

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

walking

Other

The group walked twice a week during one hour.

Other names: Rehabilitation, exercise, physical therapy

Primary outcomes

  1. Change in Pain

    Time frame: baseline, after 10 weeks, 20 weeks and 40 weeks

    Evaluated with the visual analogue scale

Secondary outcomes

  1. Change in fibromyalgia impact

    Time frame: Baseline, after 10, 20 and 40 weeks

    Evaluated using the Fibromyalgia Impact Questionnaire

  2. Change in Quality of life

    Time frame: Baseline, after 10, 20 and 40 weeks

    Evaluated using the SF-36 questionnaire

  3. Change in Body image

    Time frame: Basline, after 10, 20 and 40 weeks

    Evaluated using the Body Dismorphic Disorder Examination (BDDE) questionnaire

  4. Change in Functional capacity

    Time frame: Baseline, after 10, 20 and 40 weeks

    Evaluated using the six minute walk test

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 27, 2012
Registry last updated
Apr 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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