Art Therapy to Treat Women With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01586637
• Other study ID #: 0206/10
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2012
• Last updated: April 25, 2012
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: April 2012
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.
• Walking
The group walked twice a week during one hour.

Locations

Country	Name	City	State
Brazil	Andréia Salvador Baptista	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain	Evaluated with the visual analogue scale	baseline, after 10 weeks, 20 weeks and 40 weeks	No
Secondary	Change in fibromyalgia impact	Evaluated using the Fibromyalgia Impact Questionnaire	Baseline, after 10, 20 and 40 weeks	No
Secondary	Change in Quality of life	Evaluated using the SF-36 questionnaire	Baseline, after 10, 20 and 40 weeks	No
Secondary	Change in Body image	Evaluated using the Body Dismorphic Disorder Examination (BDDE) questionnaire	Basline, after 10, 20 and 40 weeks	No
Secondary	Change in Functional capacity	Evaluated using the six minute walk test	Baseline, after 10, 20 and 40 weeks	No