Examining the Effects of Activity Management in Women With Fibromyalgia Syndrome

NCT ID: NCT05821036

Last Updated: 2023-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-27

Study Completion Date

2023-12-27

Brief Summary

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Purpose: To determine the effects of activity management training on pain, occupational performance, quality of life, depression, anxiety and occupational balance in women with fibromyalgia syndrome (FMS).

In addition to, reducing pain, which is the main symptom of FMS, by regulating the activity-rest cycle, it is aimed to increase people's participation in daily life and improve their quality of life.

Method: A randomized controlled trial. A total of 10 sessions of individual-internet-based activity management training are applied to women with FMS in the intervention group, 2 sessions a week for 5 weeks, 1st and 10th sessions are pre- and post-training evaluation. Assessments before and after training The Revised Fibromyalgia Impact Questionnaire (FIQR), Canadian Occupational Performance Measure(COPM), Pain-activity patterns scale (Pomp/APPS) ,Nottingham Health Profile,The hospital anxiety and depression scale,The Occupational Balance Questionnaire (OBQ) is applied.Although no intervention is applied to the control group, only preliminary and final evaluations are completed.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

A randomized controlled trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Inclusion criteria:

* Having been diagnosed with FMS by a specialist physician,
* Being a woman between the ages of 18-64,
* To be literate,
* Having and actively using a smartphone or a computer

Exclusion criteria:

* Any disease accompanying FMS, the presence of psychiatric illness and endocrine disorders,
* Have previous activity management training,
* Currently and up to 4 weeks on psychotropic medication,
* Breastfeeding and pregnancy

Group Type EXPERIMENTAL

Activitiy Management

Intervention Type BEHAVIORAL

Activity Management training will be applied for 5 weeks, 2 sessions per week, and the 1st and 10th sessions will be pre and post-training evaluation, a total of 10 individual, internet-based sessions.

Week 1:Awareness training and ergonomics training including spine anatomy, correct posture use, ergonomic strategies were planned to increase awareness about FMS. Week 2:Focusing on the challenging activities stated by the individuals, it is aimed to change the behavior by arranging the activity resting cycle in daily life. In addition, the management, adaptation and modification of the activities will be provided within the scope of time management training. Week 3: Joint and energy conservation principles training will be given and it is aimed to create body mechanics and proper posture suitable for activities.Week 4: Relaxation training will be provided as a method of coping with pain.Week 5: Re-evaluation/review of the targets set to reduce pain during activities will be provided.

Control group

Inclusion criteria:

* Having been diagnosed with FMS by a specialist physician,
* Being a woman between the ages of 18-64,
* To be literate,
* Having and actively using a smartphone or a computer

Exclusion criteria:

* Any disease accompanying FMS, the presence of psychiatric illness and endocrine disorders,
* Have previous activity management training,
* Currently and up to 4 weeks on psychotropic medication,
* Breastfeeding and pregnancy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Activitiy Management

Activity Management training will be applied for 5 weeks, 2 sessions per week, and the 1st and 10th sessions will be pre and post-training evaluation, a total of 10 individual, internet-based sessions.

Week 1:Awareness training and ergonomics training including spine anatomy, correct posture use, ergonomic strategies were planned to increase awareness about FMS. Week 2:Focusing on the challenging activities stated by the individuals, it is aimed to change the behavior by arranging the activity resting cycle in daily life. In addition, the management, adaptation and modification of the activities will be provided within the scope of time management training. Week 3: Joint and energy conservation principles training will be given and it is aimed to create body mechanics and proper posture suitable for activities.Week 4: Relaxation training will be provided as a method of coping with pain.Week 5: Re-evaluation/review of the targets set to reduce pain during activities will be provided.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Having been diagnosed with FMS by a specialist physician,
* Being a woman between the ages of 18-64,
* To be literate,
* Having and actively using a smartphone or a computer

Exclusion Criteria

* Any disease accompanying FMS, the presence of psychiatric illness and endocrine disorders,
* Have previous activity management training,
* Currently and up to 4 weeks on psychotropic medication,
* Breastfeeding and pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ankara Medipol University

OTHER

Sponsor Role lead

Responsible Party

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Sena Albay

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Medipol University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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SAlbay

Identifier Type: -

Identifier Source: org_study_id

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