search
Back to results

Examining the Effects of Activity Management in Women With Fibromyalgia Syndrome

Primary Purpose

Fibromyalgia

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Activitiy Management
Sponsored by
Ankara Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, activity management, pain management, occupational balance, occupational performance, occupational therapy

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ankara Medipol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

The Revised Fibromyalgia Impact Questionnaire (FIQ/RFEA)
It is a questionnaire that evaluates the limitations and functional impairment in patients with fibromyalgia with a total of 21 questions in three sections: function, general and symptoms. All questions are evaluated on a numerical scale between 0-10. The higher the score obtained from the questionnaire, the higher the disability due to fibromyalgia. Turkish validity and reliability was performed by Ediz et al. on female patients with fibromyalgia. (Cronbach's alpha value is 0.89 for FIQR 1st visit (first assessment) and 0.91 for FIQR 2nd visit (second assessment).)
Canadian Occupational Performance Measurement (COPM)
It focuses on ocuopational performance in all areas of life, including self-care, leisure, and productivity. It is a person-centered scale created for individuals to analyze and prioritize the factors that limit their participation in ADLs. Turkish cultural adaptation, validity and reliability 2017 (Cronbach Alpha internal consistency coefficient 0.9-1.)
Patterns of Activity Measure" (POAM-P)
It analyzes the altered activity patterns of individuals with chronic pain while creating their activities. The questionnaire consists of 30 questions and all questions are evaluated on a numerical scale between 0-4. Its Turkish adaptation, validity and reliability were performed by Emine Tunç Süygün on patients with chronic low back/neck pain in 2019. (Cronbach's alpha coefficient is 0.941 for avoidance, 0.917 for overdoing, and 0.940 for regulation.)
Nottingham Health Profile (NSP)
It consists of 38 questions examining the effects of health problems on different areas of quality of life and 6 sections including physical activity, pain, sleep, social isolation, emotional reactions and energy level. These parameters are; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items), emotional reactions (9 items). Each sub-parameter is scored between 0-100. 0 indicates best health, 100 indicates worst health. Turkish validity and reliability of the questionnaire Küçükdeveci, McKenna, Kutlay et al. (2002) by
Hospital anxiety depression scale (HADS)
Hospital anxiety depression scale (HADS) was developed by Zigmoid and Snaith to examine anxiety and depression in individuals with physical illness. 7 questions of the 14-item scale question anxiety and 7 questions about depression symptoms. assessed on a four-point Likert scale. The answers given to the questions are scored between 0-3. The sum of the scores of the odd questions gives the anxiety subscale (HAD-A) score, and the sum of the scores of the even questions gives the depression subscale (HAD-D) score. The lowest score that patients can get from both subscales is 0, and the highest score is 21. The Turkish validity and reliability study of the scale was performed by Aydemir in 1997. (Cronbach's alpha coefficient 0.8525 for anxiety, 0.7784 for depression)
Ocupational Balance Questionnaire (OB-Quest)
Occupational balance, which is considered to be an important component of health and well-being, is a very important concept in occupational therapy.The concept of 'ocupational balance' is the right amount of the perception that it has the oculation and that it has the right variety between ocuations.Opations and roles in the life cycle, personal factors and ıt has a dynamic structure that changes with external factors. There is a constant transition between ocupational imbalance and balance.The Ocupational Balance Questionnaire (OB-Task) is designed as a standard tool to assess a person's ocupational balance. The questionnaire consists of 10 closed-ended questions. The Turkish validity and reliability were evaluated by Bahadır et al. in 2021. The alpha score of the Turkish OB-Quest Cronbach is 0.645 and it has questionable internal consistency.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2023
Last Updated
April 6, 2023
Sponsor
Ankara Medipol University
search

1. Study Identification

Unique Protocol Identification Number
NCT05821036
Brief Title
Examining the Effects of Activity Management in Women With Fibromyalgia Syndrome
Official Title
Examining the Effects of Activity Management in Women With Fibromyalgia Syndrome :Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 27, 2022 (Actual)
Primary Completion Date
December 27, 2023 (Anticipated)
Study Completion Date
December 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, activity management, pain management, occupational balance, occupational performance, occupational therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
A randomized controlled trial.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Activitiy Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Revised Fibromyalgia Impact Questionnaire (FIQ/RFEA)
Description
It is a questionnaire that evaluates the limitations and functional impairment in patients with fibromyalgia with a total of 21 questions in three sections: function, general and symptoms. All questions are evaluated on a numerical scale between 0-10. The higher the score obtained from the questionnaire, the higher the disability due to fibromyalgia. Turkish validity and reliability was performed by Ediz et al. on female patients with fibromyalgia. (Cronbach's alpha value is 0.89 for FIQR 1st visit (first assessment) and 0.91 for FIQR 2nd visit (second assessment).)
Time Frame
15 minute
Title
Canadian Occupational Performance Measurement (COPM)
Description
It focuses on ocuopational performance in all areas of life, including self-care, leisure, and productivity. It is a person-centered scale created for individuals to analyze and prioritize the factors that limit their participation in ADLs. Turkish cultural adaptation, validity and reliability 2017 (Cronbach Alpha internal consistency coefficient 0.9-1.)
Time Frame
20 minute
Title
Patterns of Activity Measure" (POAM-P)
Description
It analyzes the altered activity patterns of individuals with chronic pain while creating their activities. The questionnaire consists of 30 questions and all questions are evaluated on a numerical scale between 0-4. Its Turkish adaptation, validity and reliability were performed by Emine Tunç Süygün on patients with chronic low back/neck pain in 2019. (Cronbach's alpha coefficient is 0.941 for avoidance, 0.917 for overdoing, and 0.940 for regulation.)
Time Frame
15 minute
Title
Nottingham Health Profile (NSP)
Description
It consists of 38 questions examining the effects of health problems on different areas of quality of life and 6 sections including physical activity, pain, sleep, social isolation, emotional reactions and energy level. These parameters are; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items), emotional reactions (9 items). Each sub-parameter is scored between 0-100. 0 indicates best health, 100 indicates worst health. Turkish validity and reliability of the questionnaire Küçükdeveci, McKenna, Kutlay et al. (2002) by
Time Frame
15 minute
Title
Hospital anxiety depression scale (HADS)
Description
Hospital anxiety depression scale (HADS) was developed by Zigmoid and Snaith to examine anxiety and depression in individuals with physical illness. 7 questions of the 14-item scale question anxiety and 7 questions about depression symptoms. assessed on a four-point Likert scale. The answers given to the questions are scored between 0-3. The sum of the scores of the odd questions gives the anxiety subscale (HAD-A) score, and the sum of the scores of the even questions gives the depression subscale (HAD-D) score. The lowest score that patients can get from both subscales is 0, and the highest score is 21. The Turkish validity and reliability study of the scale was performed by Aydemir in 1997. (Cronbach's alpha coefficient 0.8525 for anxiety, 0.7784 for depression)
Time Frame
15 minute
Title
Ocupational Balance Questionnaire (OB-Quest)
Description
Occupational balance, which is considered to be an important component of health and well-being, is a very important concept in occupational therapy.The concept of 'ocupational balance' is the right amount of the perception that it has the oculation and that it has the right variety between ocuations.Opations and roles in the life cycle, personal factors and ıt has a dynamic structure that changes with external factors. There is a constant transition between ocupational imbalance and balance.The Ocupational Balance Questionnaire (OB-Task) is designed as a standard tool to assess a person's ocupational balance. The questionnaire consists of 10 closed-ended questions. The Turkish validity and reliability were evaluated by Bahadır et al. in 2021. The alpha score of the Turkish OB-Quest Cronbach is 0.645 and it has questionable internal consistency.
Time Frame
15 minute

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ankara Medipol University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Examining the Effects of Activity Management in Women With Fibromyalgia Syndrome

We'll reach out to this number within 24 hrs