Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296446
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-02-28
Brief Title:
Disability of People With Fibromyalgia in Poland
Sponsor:
University of Rzeszow
Organization:
University of Rzeszow
Study Overview
Official Title:
Assessment of Functioning and Disability of People With Fibrimyalgia in Poland
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fibromyalgia is a syndrome characterized by chronic generalized pain in muscles and joints with the presence of characteristic symmetrically occurring so-called tender points - areas of the body that are excessively sensitive to pressure The condition is associated with a feeling of chronic fatigue mood and sleep disturbances and a sensation of body stiffness These complaints are bothersome and significantly impair patients functioning in every aspect of their lives There are few studies evaluating the functioning and disability of people with fibromyalgia No such study has been conducted in Poland to date Therefore the purpose of this study is to evaluate the functioning and disability of fibromyalgia patients and the relationship of the level of disability with selected factors such as pain intensity emotional state sleep quality etc
Detailed Description:
Fibromyalgia is a disease syndrome characterized by chronic generalized muscle and joint pain with characteristic symmetrical so-called tender points ie places of the body excessively sensitive to pressure This disease is associated with the feeling of chronic fatigue mood and sleep disorders and the feeling of body stiffness These ailments are troublesome and significantly worsen the functioning of patients in every aspect of their lives There is little research examining functioning and disability in people with fibromyalgia No such study has been conducted in Poland so far Therefore the aim of the study is to assess the functioning and disability of people suffering from fibromyalgia and the relationship between the level of disability and selected factors such as pain intensity emotional state sleep quality etc
The study will be conducted among people suffering from fibromyalgia and associated with the National Association of Fibromyalgia Patients FIBRO-MY The study will be conducted using an online survey created in a Google form The survey will include such research tools as WHODAS 20 disability assessment questionnaire Fibromyalgia Impact Questionnaire FIQ Beck Depression Inventory BDI The study will be conducted based on the International Classification of Functioning Disability and Health Appropriate statistical models will be selected to analyze the data and the results will be presented in a descriptive form
Description of research tools
1 The WHO Disability Assessment Schedule WHODAS 20 36-item is used to measure general disability and disability in six domains Do1 Cognition 6 items Do2 Mobility 5 items Do3 Self-care 4 items Do4 Getting along 5 items Do5 Life activities 8 items and Do6 Participation 8 items During the interview the response refers to the last 30 days Answers to the questions are rated on a 5-point scale identifying the level of di culty or problem 1 none 2 mild 3 moderate 4 severe 5 extreme or cannot to do The obtained results are converted according to the instructions on the scale from 0 to 100 When assessing the level of disability with the WHODAS 20 the following scale consistent with the ICF was used no disability or an insufficient problem 0-4 mild disability or a small problem 5-24 moderate disability or a significant problem 25-49 severe disability or a big problem 50-95 and extreme disability or a total problem 96-100
2 The Fibromyalgia Impact Questionnaire FIQ The FIQ questionnaire allows us to assess the impact of fibromyalgia on the quality of life of patients The reminder period for FIQ is 1 week FIQ consists of 20 items examining 10 subscales scoring dimensions Physical functioning Well-being Work related Do work Pain Fatigue Rested Stiffness Anxiety Depression Individual domains are scored according to the conversion key Once the initial scoring is complete the scores obtained are converted to normalized scores from 0 to 10 with 0 meaning no impairment and 10 meaning maximum impairment The total score is expressed on a scale of 0-100 Higher scores mean a greater negative impact of the disease on the patients quality of life
3 The Becks Depression Inventory BDI The BDI contains 21 items on a 4-point scale ranging from 0 no symptoms to 3 severe symptoms The reminder period for BDI is 2 weeks Anxiety symptoms are not assessed but affective cognitive somatic and vegetative symptoms are considered reflecting the Diagnostic and Statistical Manual DSM-IV criteria for major depression The minimum score is 0 and the maximum score is 63 Higher scores indicate greater severity of symptoms In non-clinical populations scores above 20 indicate depression In people diagnosed with depression scores of 0-13 indicate minimal depression 14-19 mild depression 20-28 moderate depression and 29-63 severe depression
At least 700 people are planned to be included in the study The study will cover people belonging to the National Association of Fibromyalgia Patients FIBRO-MY These will be adults diagnosed with fibromyalgia who give informed consent to participate in the study and decide to complete the electronic survey Since the study will be conducted based on an anonymous online survey at the beginning of the study there will be information about expressing informed consent to participate in the study and a note that completing the survey is a confirmation of consent
The study will be conducted among people suffering from fibromyalgia and associated with the National Association of Fibromyalgia Patients FIBRO-MY The study will be conducted using an online survey created in a Google form The survey will include such research tools as WHODAS 20 disability assessment questionnaire Fibromyalgia Impact Questionnaire FIQ Beck Depression Inventory BDI The study will be conducted based on the International Classification of Functioning Disability and Health Appropriate statistical models will be selected to analyze the data and the results will be presented in a descriptive form
Description of research tools
1 The WHO Disability Assessment Schedule WHODAS 20 36-item is used to measure general disability and disability in six domains Do1 Cognition 6 items Do2 Mobility 5 items Do3 Self-care 4 items Do4 Getting along 5 items Do5 Life activities 8 items and Do6 Participation 8 items During the interview the response refers to the last 30 days Answers to the questions are rated on a 5-point scale identifying the level of di culty or problem 1 none 2 mild 3 moderate 4 severe 5 extreme or cannot to do The obtained results are converted according to the instructions on the scale from 0 to 100 When assessing the level of disability with the WHODAS 20 the following scale consistent with the ICF was used no disability or an insufficient problem 0-4 mild disability or a small problem 5-24 moderate disability or a significant problem 25-49 severe disability or a big problem 50-95 and extreme disability or a total problem 96-100
2 The Fibromyalgia Impact Questionnaire FIQ The FIQ questionnaire allows us to assess the impact of fibromyalgia on the quality of life of patients The reminder period for FIQ is 1 week FIQ consists of 20 items examining 10 subscales scoring dimensions Physical functioning Well-being Work related Do work Pain Fatigue Rested Stiffness Anxiety Depression Individual domains are scored according to the conversion key Once the initial scoring is complete the scores obtained are converted to normalized scores from 0 to 10 with 0 meaning no impairment and 10 meaning maximum impairment The total score is expressed on a scale of 0-100 Higher scores mean a greater negative impact of the disease on the patients quality of life
3 The Becks Depression Inventory BDI The BDI contains 21 items on a 4-point scale ranging from 0 no symptoms to 3 severe symptoms The reminder period for BDI is 2 weeks Anxiety symptoms are not assessed but affective cognitive somatic and vegetative symptoms are considered reflecting the Diagnostic and Statistical Manual DSM-IV criteria for major depression The minimum score is 0 and the maximum score is 63 Higher scores indicate greater severity of symptoms In non-clinical populations scores above 20 indicate depression In people diagnosed with depression scores of 0-13 indicate minimal depression 14-19 mild depression 20-28 moderate depression and 29-63 severe depression
At least 700 people are planned to be included in the study The study will cover people belonging to the National Association of Fibromyalgia Patients FIBRO-MY These will be adults diagnosed with fibromyalgia who give informed consent to participate in the study and decide to complete the electronic survey Since the study will be conducted based on an anonymous online survey at the beginning of the study there will be information about expressing informed consent to participate in the study and a note that completing the survey is a confirmation of consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None