FibromyalgiaNCT05252611
The Validity and Reliability of the Turkish Version of the CPAQ-8
An observational study of Fibromyalgia and Chronic Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Acceptance of chronic pain is becoming an increasingly important issue in the field of pain management. Many researchers argue that patients who accept pain better function better both physically and psychologically. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia, Chronic Pain
- What is being tested?
- Turkish version of the Chronic Pain Acceptance Questionnaire-8 (CPAQ-8)
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 31 Dec 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who applied to our physical medicine and rehabilitation outpatient clinic, agreed to participate in the study, were over the age of 18, had at least primary school education, were diagnosed with fibromyalgia syndrome according to the 2016 American College of Rheumatology (ACR) criteria, and could speak and communicate in Turkish were included in the study.
Who may be able to join
- Patients who applied to our physical medicine and rehabilitation outpatient clinic,
- Agreed to participate in the study, were over the age of 18,
- Had at least primary school education, were diagnosed with fibromyalgia syndrome according to the 2016 American College of Rheumatology (ACR) criteria,
- Could speak and communicate in Turkish were included in the study.
Who cannot join
- Those who did not agree to participate in the study,
- <18 years old, and could not communicate in Turkish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Validity and Reliability of the Turkish Version of the Chronic Pain Acceptance Questionnaire-8
Acceptance of chronic pain is becoming an increasingly important issue in the field of pain management. Many researchers argue that patients who accept pain better function better both physically and psychologically. In many countries, the Chronic Pain Acceptance Questionnaire - 8 (CPAQ-8) has been frequently validated and used to measure the pain acceptance of patients with chronic pain.1 However, the CPAQ-8 has not yet been introduced and validated in Turkey. In this study, we aimed to translate the English version of CPAQ-8 into Turkish, make correct cross-cultural adaptations, and validate the psychometric properties of the Turkish version of CPAQ-8 by testing it in Turkish fibromyalgia patients.
Read the detailed description
Chronic pain is an undesirable condition that affects a large part of the society and increases the psychological and economic burden of the population it affects. Psychological variables are known to be strong in the perception of pain and especially cause patients to avoid activity in order to reduce pain. Individuals prefer to avoid painful experiences when they are worn out in repetitive attempts to control and prevent pain, which ultimately causes pain to become more dominant and destructive, and activities that are valuable to the individual are neglected.1 At this point, accepting pain can be seen as the antithesis of avoiding painful experiences. Acceptance of pain is a strong predictor of low disability in chronic pain.2 The Chronic Pain Acceptance Questionnaire (CPAQ) represents one of the ways in which pain acceptance is functionalized and measured in the context of chronic pain. The short form of CPAQ, CPAQ-8, was developed and validated recently and shows the same factor structure, reliability and validity as the 20-factor version. Given that psychometric testing is an incremental process, further evaluation of the questionnaire is desirable, including test-retest reliability and replication of results reported by Fish et al.
- Conditions
- Fibromyalgia, Chronic Pain
- Being tested
- Turkish version of the Chronic Pain Acceptance Questionnaire-8 (CPAQ-8)
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish version of the Chronic Pain Acceptance Questionnaire-8 (CPAQ-8)Other
The aim of this study is to test the validity of the Turkish version of the Chronic Pain Acceptance Questionnaire-8 (CPAQ-8).
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire
The Fibromyalgia Impact Questionnaire was used to measure patients' symptom severity and functional status. There are 10 items in the FIQ; each item gets a score between 0-10. The first item questions the ability to perform activities of daily living with 11 questions. Other items question general well-being, ability to work, and symptoms of pain, fatigue, stiffness, anxiety, and depression. The score range is 0 to 100; higher scores indicate severe disease.
Measured: 01.01.2020-31.12.2021
Secondary outcomes (3)
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale (HADS) consists of 14 items. It is designed to assess the severity of anxiety and depression in patients.Each item is scored between 0-3; higher scores indicate more anxiety or depression.
Measured: 01.01.2020-31.12.2021
Tampa Scale of Kinesiophobia
Tampa Scale of Kinesiophobia (TSK) is a 17 item self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. . Scoring ranges from 1 to 4 points for each item, with higher scores indicating greater fear of injury.
Measured: 01.01.2020-31.12.2021
Brief Pain Inventory
Brief Pain Inventory consists of four questions about the severity of pain and seven questions about its effect on daily functions. The inventory assesses an individual's walking, exercise, sleep, emotional state, general activity status, social relations, and joy in the last 24 hours. Each item gets scored between 0 and 10, ; higher scores indicate severe disease.
Measured: 01.01.2020-31.12.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Jan 2020
- Primary completion1 Jan 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Kivanc Menekseoglu, Istanbul University
- Investigators
- Ahmet K Menekşeoğlu, Principal investigator, Kanuni Sultan Süleyman Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252611
- Sponsor's protocol ID
- 2019/58
- Status last verified
- Feb 2022
- First submitted
- 12 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fish RA, Hogan MJ, Morrison TG, Stewart I, McGuire BE. Willing and able: a closer look at pain Willingness and Activity Engagement on the Chronic Pain Acceptance Questionnaire (CPAQ-8). J Pain. 2013 Mar;14(3):233-45. doi: 10.1016/j.jpain.2012.11.004.
PubMed 23452647Fish RA, McGuire B, Hogan M, Morrison TG, Stewart I. Validation of the chronic pain acceptance questionnaire (CPAQ) in an Internet sample and development and preliminary validation of the CPAQ-8. Pain. 2010 Jun;149(3):435-443. doi: 10.1016/j.pain.2009.12.016. Epub 2010 Feb 25.
PubMed 20188472Kleinebrecht J, Degenhardt KH, Franz J, Schneider G. Variability of limb malformations induced by 5-fluoro-2'-deoxycytidine in mice. Teratology. 1972 Jun;5(3):295-301. doi: 10.1002/tera.1420050304. No abstract available.
PubMed 5032639
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of the Turkish Version of the Chronic Pain Acceptance Questionnaire-8
- ClinicalTrials.gov ID
- NCT05252611
- Acronym / sponsor ID
- 2019/58
- Conditions
- Fibromyalgia, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acceptance of chronic pain is becoming an increasingly important issue in the field of pain management. Many researchers argue that patients who accept pain better function better both physically and psychologically. In many countries, the Chronic Pain Acceptance Questionnaire - 8 (CPAQ-8) has been frequently validated and used to measure the pain acceptance of patients with chronic pain.1 However, the CPAQ-8 has not yet been introduced and validated in Turkey. In this study, we aimed to translate the English version of CPAQ-8 into Turkish, make correct cross-cultural adaptations, and validate the psychometric properties of the Turkish version of CPAQ-8 by testing it in Turkish fibromyalgia patients.
Detailed description
Chronic pain is an undesirable condition that affects a large part of the society and increases the psychological and economic burden of the population it affects. Psychological variables are known to be strong in the perception of pain and especially cause patients to avoid activity in order to reduce pain. Individuals prefer to avoid painful experiences when they are worn out in repetitive attempts to control and prevent pain, which ultimately causes pain to become more dominant and destructive, and activities that are valuable to the individual are neglected.1 At this point, accepting pain can be seen as the antithesis of avoiding painful experiences. Acceptance of pain is a strong predictor of low disability in chronic pain.2 The Chronic Pain Acceptance Questionnaire (CPAQ) represents one of the ways in which pain acceptance is functionalized and measured in the context of chronic pain. The short form of CPAQ, CPAQ-8, was developed and validated recently and shows the same factor structure, reliability and validity as the 20-factor version. Given that psychometric testing is an incremental process, further evaluation of the questionnaire is desirable, including test-retest reliability and replication of results reported by Fish et al.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who applied to our physical medicine and rehabilitation outpatient clinic, agreed to participate in the study, were over the age of 18, had at least primary school education, were diagnosed with fibromyalgia syndrome according to the 2016 American College of Rheumatology (ACR) criteria, and could speak and communicate in Turkish were included in the study.
Key inclusion criteria (4 listed)
- Patients who applied to our physical medicine and rehabilitation outpatient clinic,
- Agreed to participate in the study, were over the age of 18,
- Had at least primary school education, were diagnosed with fibromyalgia syndrome according to the 2016 American College of Rheumatology (ACR) criteria,
- Could speak and communicate in Turkish were included in the study.
Key exclusion criteria (2 listed)
- Those who did not agree to participate in the study,
- <18 years old, and could not communicate in Turkish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turkish version of the Chronic Pain Acceptance Questionnaire-8 (CPAQ-8)The aim of this study is to test the validity of the Turkish version of the Chronic Pain Acceptance Questionnaire-8 (CPAQ-8). | Other | – |
Primary outcome
Fibromyalgia Impact Questionnaire
Time frame: 01.01.2020-31.12.2021
The Fibromyalgia Impact Questionnaire was used to measure patients' symptom severity and functional status. There are 10 items in the FIQ; each item gets a score between 0-10. The first item questions the ability to perform activities of daily living with 11 questions. Other items question general well-being, ability to work, and symptoms of pain, fatigue, stiffness, anxiety, and depression. The score range is 0 to 100; higher scores indicate severe disease.
3 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: 01.01.2020-31.12.2021
Tampa Scale of Kinesiophobia
Time frame: 01.01.2020-31.12.2021
Brief Pain Inventory
Time frame: 01.01.2020-31.12.2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Background: PubMed 23452647Fish RA, Hogan MJ, Morrison TG, Stewart I, McGuire BE. Willing and able: a closer look at pain Willingness and Activity Engagement on the Chronic Pain Acceptance Questionnaire (CPAQ-8). J Pain. 2013 Mar;14(3):233-45. doi: 10.1016/j.jpain.2012.11.004.
- Results publication: PubMed 20188472Fish RA, McGuire B, Hogan M, Morrison TG, Stewart I. Validation of the chronic pain acceptance questionnaire (CPAQ) in an Internet sample and development and preliminary validation of the CPAQ-8. Pain. 2010 Jun;149(3):435-443. doi: 10.1016/j.pain.2009.12.016. Epub 2010 Feb 25.
- Results publication: PubMed 5032639Kleinebrecht J, Degenhardt KH, Franz J, Schneider G. Variability of limb malformations induced by 5-fluoro-2'-deoxycytidine in mice. Teratology. 1972 Jun;5(3):295-301. doi: 10.1002/tera.1420050304. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet K Menekşeoğlu principal investigator
Kanuni Sultan Süleyman Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Chronic Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire (time frame: 01.01.2020-31.12.2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05252611, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.