Chronic PainNCT05436353
Turkish Version of The Conceptualization of Pain Questionnaire
An observational study of Chronic Pain, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The Conceptualization of Pain Questionnaire (COPAQ), has been presented to the literature in order to evaluate the concept of pain in children and its psychometric properties. This scale, which was developed by Salvat et al., is stated as a tool that consists of a total of 15 items and is easy to administer and… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Turkish validity and reliability
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jul 2022to 1 Feb 2024
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants who refferred to Pamukkale University Rheumatology Clinic will be examined by one of the researchers (specialist in rheumatology) for inclusion and exclusion criteria.
Who may be able to join
- Diagnosed with FMF (Familial Mediterranean Fever) according to the "Tel Hashomer" diagnostic criteria
- Speak Turkish
- Willing to participate
Who cannot join
- The presence of another systemic disease.
- Intraarticular steroid injection or surgery in any joint in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Relaibility of Turkish Version of The Conceptualization of Pain Questionnaire
The Conceptualization of Pain Questionnaire (COPAQ), has been presented to the literature in order to evaluate the concept of pain in children and its psychometric properties. This scale, which was developed by Salvat et al., is stated as a tool that consists of a total of 15 items and is easy to administer and respond to. The total score is calculated with the correct or incorrect answers given by the children to these items, and the higher this score, the better the child's understanding of the concept of pain. Moreover; it has been shown that the scale has good fit and internal consistency. In Turkey, there is no valid and reliable scale to evaluate the concept of pain in a child with chronic pain.
The aim of this study is to create the Turkish version of "The Conceptualization of Pain Questionnaire (COPAQ)", which evaluates the concept of pain in children with chronic pain, and to question the Turkish validity and reliability of this scale.
Read the detailed description
Chronic pain is a debilitating health problem often seen in children and adolescents. Although the prevalence rate varies between 11% and 38%, this rate increases with age (1). Clinical guidelines recommend that healthcare professionals help children with chronic pain understand their pain experience (2). Studies have shown that there is a relationship between the quality of the information children receive and their adaptation to and coping with pain (3). For this reason, studies in the field of pediatrics have turned to pain neuroscience education, which provides the reconceptualization of pain through education (3). Pain neuroscience education provides the basis for understanding the mechanisms of chronic pain by focusing on the biopsychosocial markers of pain (3). A pain neuroscience training protocol called 'PNE4Kids' specific to children has been introduced in the literature and it has been explained how this training should be applied to children (4). The effectiveness of the "PNE4Kids Program" has been investigated with new studies and it has been proven that it has a positive effect on the concept of pain in children and increases their knowledge of pain (5). However, there are very few scales evaluating the effectiveness of these treatments and especially the level of pain knowledge in children (6). Recently, a new scale, The Conceptualization of Pain Questionnaire (COPAQ), has been presented to the literature in order to evaluate the concept of pain in children and its psychometric properties. This scale, which was developed by Salvat et al (6), is stated as a tool that consists of a total of 15 items and is easy to administer and respond to. The total score is calculated with the correct or incorrect answers given by the children to these items, and the higher this score, the better the child's understanding of the concept of pain. Moreover; it has been shown that the scale has good fit and internal consistency (6). In our country, there is no valid and reliable scale to evaluate the concept of pain in a child with chronic pain. The aim of this study is to create the Turkish version of "The Conceptualization of Pain Questionnaire (COPAQ)", which evaluates the concept of pain in children with chronic pain, and to question the Turkish validity and reliability of this scale.
References
- King S, Chambers CT, Huguet A, et al. The epidemiology of chronic pain in children and adolescents revisited: a systematic review. Pain 2011;152(12): 2729-2738.
- Palermo TM, et al. "Assessment and management of children with chronic pain: A position statement from the American Pain Society. Chicago, IL: Am Pain Soc" 2012.
- Robins H, Perron V, Heathcote LC et al. Pain neuroscience education: state of the art and application in pediatrics. Children 2016;3(4):43.
- Pas R, Meeus M, Malfliet A, et al. Development and feasibility testing of a Pain Neuroscience Education program for children with chronic pain: Treatment protocol. Braz J Phys Ther 2018;22(3):248-253.
- Rheel E, Ickmans K., Wauters A, et al. The effect of a pain educational video intervention upon child pain-related outcomes: A randomized controlled study. Eur J Pain 2021;25(10):2094-2111.
- Salvat I, Adillón C, Andrés E M et al. Development of the conceptualization of pain questionnaire: A measure to study how children conceptualize pain. Int J Environ Res Public Health 2021;18(7):3821.
- Conditions
- Chronic Pain
- Being tested
- Turkish validity and reliability
- Keywords
- pain, chronic pain, attitudes and beliefs, children
- Medical subject headings
- Chronic Pain, Pain, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish validity and reliabilityOther
Contact with developers and formation of steering committee Translation from English to Turkish Back translation from Turkish to English Comparison of translation Review of translated versions. Reaching consensus and development of pilot version Testing in clinical setting Revision of pilot version Testing of final version
What is being measured
The primary outcome is the main question the study is designed to answer.
The Turkish version of Conceptualization of Pain Questionnaire (COPAQ-TR
COPAQ-TR consist of 15 items and asks respondents to respond if they believe the items/statements to be true or false, although they are allowed to respond undecided. A score of 0 is given to incorrect responses and those marked as undecided; the sum of all the correct answers gives the total score. The higher the score, the better the participant understands the concept of pain.
Measured: 10 minutes
Turkish version ofPediatric Quality of Life Scale (PedsQL-TR)
The Pediatric Quality of Life Inventory (PedsQL) is a 23-item generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents ages 2 to 18.
Measured: 10 minutes
Turkish version of Child Health Assessment Scale (CHAQ-TR)
CHAQ he Childhood Health Assessment Questionnaire (CHAQ) is a disease specific health instrument that measures functional ability in daily living activities.This 30-item questionnaire is thought to have advantages over other measures of physical function due to such aspects as its multidimensionality (it assesses 8 domains of physical function).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start4 Jul 2022
- Primary completion15 May 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University
- Responsible party
- Principal investigator, Ismail Saracoglu, Kutahya Health Sciences University
- Investigators
- Bilge Başakçı ÇALIK, Prof., Study chair, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436353
- Sponsor's protocol ID
- COPAQpauksbu
- Status last verified
- Feb 2024
- First submitted
- 23 Jun 2022
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Relaibility of Turkish Version of The Conceptualization of Pain Questionnaire
- ClinicalTrials.gov ID
- NCT05436353
- Acronym / sponsor ID
- COPAQpauksbu
- Conditions
- Chronic Pain
- Keywords
- pain, chronic pain, attitudes and beliefs, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Collaborators
- Pamukkale University
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 29 Jun 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.
The Conceptualization of Pain Questionnaire (COPAQ), has been presented to the literature in order to evaluate the concept of pain in children and its psychometric properties. This scale, which was developed by Salvat et al., is stated as a tool that consists of a total of 15 items and is easy to administer and respond to. The total score is calculated with the correct or incorrect answers given by the children to these items, and the higher this score, the better the child's understanding of the concept of pain. Moreover; it has been shown that the scale has good fit and internal consistency. In Turkey, there is no valid and reliable scale to evaluate the concept of pain in a child with chronic pain.
The aim of this study is to create the Turkish version of "The Conceptualization of Pain Questionnaire (COPAQ)", which evaluates the concept of pain in children with chronic pain, and to question the Turkish validity and reliability of this scale.
Detailed description
Chronic pain is a debilitating health problem often seen in children and adolescents. Although the prevalence rate varies between 11% and 38%, this rate increases with age (1). Clinical guidelines recommend that healthcare professionals help children with chronic pain understand their pain experience (2). Studies have shown that there is a relationship between the quality of the information children receive and their adaptation to and coping with pain (3). For this reason, studies in the field of pediatrics have turned to pain neuroscience education, which provides the reconceptualization of pain through education (3). Pain neuroscience education provides the basis for understanding the mechanisms of chronic pain by focusing on the biopsychosocial markers of pain (3). A pain neuroscience training protocol called 'PNE4Kids' specific to children has been introduced in the literature and it has been explained how this training should be applied to children (4). The effectiveness of the "PNE4Kids Program" has been investigated with new studies and it has been proven that it has a positive effect on the concept of pain in children and increases their knowledge of pain (5). However, there are very few scales evaluating the effectiveness of these treatments and especially the level of pain knowledge in children (6). Recently, a new scale, The Conceptualization of Pain Questionnaire (COPAQ), has been presented to the literature in order to evaluate the concept of pain in children and its psychometric properties. This scale, which was developed by Salvat et al (6), is stated as a tool that consists of a total of 15 items and is easy to administer and respond to. The total score is calculated with the correct or incorrect answers given by the children to these items, and the higher this score, the better the child's understanding of the concept of pain. Moreover; it has been shown that the scale has good fit and internal consistency (6). In our country, there is no valid and reliable scale to evaluate the concept of pain in a child with chronic pain. The aim of this study is to create the Turkish version of "The Conceptualization of Pain Questionnaire (COPAQ)", which evaluates the concept of pain in children with chronic pain, and to question the Turkish validity and reliability of this scale.
References
- King S, Chambers CT, Huguet A, et al. The epidemiology of chronic pain in children and adolescents revisited: a systematic review. Pain 2011;152(12): 2729-2738.
- Palermo TM, et al. "Assessment and management of children with chronic pain: A position statement from the American Pain Society. Chicago, IL: Am Pain Soc" 2012.
- Robins H, Perron V, Heathcote LC et al. Pain neuroscience education: state of the art and application in pediatrics. Children 2016;3(4):43.
- Pas R, Meeus M, Malfliet A, et al. Development and feasibility testing of a Pain Neuroscience Education program for children with chronic pain: Treatment protocol. Braz J Phys Ther 2018;22(3):248-253.
- Rheel E, Ickmans K., Wauters A, et al. The effect of a pain educational video intervention upon child pain-related outcomes: A randomized controlled study. Eur J Pain 2021;25(10):2094-2111.
- Salvat I, Adillón C, Andrés E M et al. Development of the conceptualization of pain questionnaire: A measure to study how children conceptualize pain. Int J Environ Res Public Health 2021;18(7):3821.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants who refferred to Pamukkale University Rheumatology Clinic will be examined by one of the researchers (specialist in rheumatology) for inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- Diagnosed with FMF (Familial Mediterranean Fever) according to the "Tel Hashomer" diagnostic criteria
- Speak Turkish
- Willing to participate
Key exclusion criteria (2 listed)
- The presence of another systemic disease.
- Intraarticular steroid injection or surgery in any joint in the last 3 months
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 validity and reliabilityContact with developers and formation of steering committee Translation from English to Turkish Back translation from Turkish to English Comparison of translation Review of translated versions. Reaching consensus and development of pilot version Testing in clinical setting Revision of pilot version Testing of final version | Other | – |
Primary outcome
The Turkish version of Conceptualization of Pain Questionnaire (COPAQ-TR
Time frame: 10 minutes
COPAQ-TR consist of 15 items and asks respondents to respond if they believe the items/statements to be true or false, although they are allowed to respond undecided. A score of 0 is given to incorrect responses and those marked as undecided; the sum of all the correct answers gives the total score. The higher the score, the better the participant understands the concept of pain.
Turkish version ofPediatric Quality of Life Scale (PedsQL-TR)
Time frame: 10 minutes
The Pediatric Quality of Life Inventory (PedsQL) is a 23-item generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents ages 2 to 18.
Turkish version of Child Health Assessment Scale (CHAQ-TR)
Time frame: 10 minutes
CHAQ he Childhood Health Assessment Questionnaire (CHAQ) is a disease specific health instrument that measures functional ability in daily living activities.This 30-item questionnaire is thought to have advantages over other measures of physical function due to such aspects as its multidimensionality (it assesses 8 domains of physical function).
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 Feb 2024.
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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.
Bilge Başakçı ÇALIK, Prof. study chair
Pamukkale University
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 Chronic Pain, run by Kutahya Health Sciences 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 3 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 Feb 2024. 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?
The Turkish version of Conceptualization of Pain Questionnaire (COPAQ-TR (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2024.