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Art Therapy to Treat Women With Fibromyalgia

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Art Therapy

Walking

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Art Therapy, Pain, Quality of life, Body Image

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Andréia Salvador Baptista

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Art Therapy

Walking

Arm Description

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.

The group walked twice a week during one hour.

Outcomes

Primary Outcome Measures

Change in Pain

Evaluated with the visual analogue scale

Secondary Outcome Measures

Change in fibromyalgia impact

Evaluated using the Fibromyalgia Impact Questionnaire

Change in Quality of life

Evaluated using the SF-36 questionnaire

Change in Body image

Evaluated using the Body Dismorphic Disorder Examination (BDDE) questionnaire

Change in Functional capacity

Evaluated using the six minute walk test

Full Information

NCT ID

NCT01586637

First Posted

February 16, 2012

Last Updated

April 25, 2012

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT01586637

Brief Title

Art Therapy to Treat Women With Fibromyalgia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Fibromyalgia, Art Therapy, Pain, Quality of life, Body Image

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Art Therapy

Arm Type

Experimental

Arm Description

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.

Arm Title

Walking

Arm Type

Experimental

Arm Description

The group walked twice a week during one hour.

Intervention Type

Other

Intervention Name(s)

Art Therapy

Other Intervention Name(s)

Rehabilitation, exercise, physical therapy

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Walking

Other Intervention Name(s)

Rehabilitation, exercise, physical therapy

Intervention Description

The group walked twice a week during one hour.

Primary Outcome Measure Information:

Title

Change in Pain

Description

Evaluated with the visual analogue scale

Time Frame

baseline, after 10 weeks, 20 weeks and 40 weeks

Secondary Outcome Measure Information:

Title

Change in fibromyalgia impact

Description

Evaluated using the Fibromyalgia Impact Questionnaire

Time Frame

Baseline, after 10, 20 and 40 weeks

Title

Change in Quality of life

Description

Evaluated using the SF-36 questionnaire

Time Frame

Baseline, after 10, 20 and 40 weeks

Title

Change in Body image

Description

Evaluated using the Body Dismorphic Disorder Examination (BDDE) questionnaire

Time Frame

Basline, after 10, 20 and 40 weeks

Title

Change in Functional capacity

Description

Evaluated using the six minute walk test

Time Frame

Baseline, after 10, 20 and 40 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andréia S Baptista, PT, MSc

Organizational Affiliation

Federal University of São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Andréia Salvador Baptista

City

São Paulo

ZIP/Postal Code

03237070

Country

Brazil

12. IPD Sharing Statement

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Art Therapy to Treat Women With Fibromyalgia

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