Chronic PainNCT05422443
The Turkish Version of Pain Coping Questionnaire
An observational study of Chronic Pain, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Biological, psychological, and social factors all influence a child's sense of pain. Pain beliefs can have a significant impact on a person's perception of pain and adherence to treatment. As a result, pain management requires a thorough examination of the factors that influence pain perception. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- How many people
- 330 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Sep 2022to 12 Aug 2023
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children are diagnosed with chronic pain and their parents Children without chronic pain and their parents
Who may be able to join
- Age between 6 years and 18 years;
- Diagnosed with chronic pain.
- To have the cognitive ability to answer questions for assessment.
- Completing the test-retest assessment.
- To be able to read and speak Turkish
- Healthy children aged 6-18 years old
- Children without a psychiatric and neurological diagnosis
Who cannot join
- Patients with unmanageable psychological disorders (e.g., attention deficit hyperactivity disorder, autistic spectrum disorder, schizophrenia, bipolar disorder, major depressive disorder) would be excluded from the study.
- Patients who started a new treatment during the trial or 6 weeks before to the study for chronic pain.
- Those who take analgesics 48 hours prior to study evaluations
- Children got medical treatment for a neuropsychiatric disorder
- Children whose parents or themselves refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Turkish Adaptation, Validity, and Reliability Study of the Pain Coping Questionnaire
Biological, psychological, and social factors all influence a child's sense of pain. Pain beliefs can have a significant impact on a person's perception of pain and adherence to treatment. As a result, pain management requires a thorough examination of the factors that influence pain perception. Coping is a cognitive and behavioral response to conditions and threats based on by personal or environmental factors. Children who do not have adequate coping mechanisms suffer from more severe pain. As a result, dealing with pain is a crucial part of pain management. This highlights the need of assessing pain coping in children when treating chronic pain. The purpose of this study is to show that the Turkish version of the Pain Coping Questionnaire (PCQ), which assesses children's pain coping techniques, is valid and reliable, as well as to ensure that it is culturally appropriate.
Read the detailed description
Pain is a biopsychosocial term that comprises sensory, cognitive, and emotional factors. The biological, psychological, and cognitive aspects of pain are all present. Pain symptoms and comorbid symptoms are biological characteristics; anxiety, depression, and rage are psychological characteristics; and the ability to cope, catastrophize, and manage pain are cognitive characteristics. As a result, pain is influenced by a person's past experiences and beliefs. Pain that lasts longer than three months is referred to as chronic pain. A major issue is the high prevalence of chronic pain in children. Children with chronic pain have a lower quality of life than their healthy peers. Furthermore, this effect is unrelated to the degree of biological damage. Some children are more sensitive to pain than others, regardless of the severity of the condition. Because psychological, cognitive, and social variables influence an individual's perception of pain in addition to biological tissue damage.
The use of coping techniques in children varies based on the diagnosis, age, and gender of the child, according to the literature. Inadequate coping techniques are linked to a lower quality of life and increased pain severity. As a result, pain assessment in children with chronic pain should be done within a biopsychosocial framework. Various assessments have been developed to assess children's pain tolerating abilities. The Pain Coping Questionnaire (PCQ) was created to evaluate problem-focused, emotional-focused, and avoidance-focused coping strategies in children. It's the most commonly used scale for assessing children's coping techniques. The purpose of this study is to show that the Turkish version of the Pain Coping Questionnaire is valid and reliable (PCQ).
- Conditions
- Chronic Pain
- Keywords
- pain, children, coping
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain group | Children with chronic pain | |
| Health group | children without chronic pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of coping strategies
Pain Coping Questionnaire: Evaluates the coping strategies of children and adolescents with a total of 39 items in 8 subscale. These are seeking knowledge, problem solving, seeking social support, positive self-suggestion, behavioral distraction, cognitive distraction, externalization, and internalization/catastrophizing. Items are assessed on a 5-point Likert scale, with 1 indicating never and 5 indicating very often. Higher ratings indicate higher use of coping strategy. PCQ consists of parent and adolescent form.
Measured: Baseline
Evaluation of pain
Wong baker faces pain scale: It is a valid and reliable scale preferred by children and their families to evaluate the severity of pain. It consists of 6 facial expressions that symbolize the severity of pain. These show the stages of increased pain from a smiling face (0 points) to a very sad and crying face (10 points). The meaning of each facial expression is carefully explained to the child. Children rate pain intensity according to face shapes.
Measured: Baseline
Secondary outcomes (1)
Evaluation of pain acceptance
Pain Flexibility Scale for Children: The scale assesses children's pain acceptance in chronic pain.It has a total of 20 questions divided into two sub-sections: valued activities and pain resistance. Pain resistance examines pain avoidance and control, whereas valued behaviors assesses involvement in meaningful activities despite pain. The scale is a seven-point Likert scale, with 0 indicating total disagreement (never true), and 6 indicating total agreement (Always true).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start8 Sep 2022
- Primary completion8 Aug 2023 (estimated)
- Study completion12 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgun Kaya Kara, Akdeniz University
- Investigators
- Ozgun Kaya Kara, Assoc. Prof., Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422443
- Sponsor's protocol ID
- 2022-125
- Status last verified
- May 2023
- First submitted
- 8 Jun 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study result will be published to the journal
Publications
Liossi C, Howard RF. Pediatric Chronic Pain: Biopsychosocial Assessment and Formulation. Pediatrics. 2016 Nov;138(5):e20160331. doi: 10.1542/peds.2016-0331. Epub 2016 Oct 14.
PubMed 27940762Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available.
PubMed 25844555Huguet A, Miro J. The severity of chronic pediatric pain: an epidemiological study. J Pain. 2008 Mar;9(3):226-36. doi: 10.1016/j.jpain.2007.10.015. Epub 2007 Dec 21.
PubMed 18088558Fraga MM, Terreri MT, Azevedo RT, Hilario MOE, Len CA. PAIN PERCEPTION AND PAIN COPING MECHANISMS IN CHILDREN AND ADOLESCENTS WITH JUVENILE FIBROMYALGIA AND POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS. Rev Paul Pediatr. 2019 Jan-Mar;37(1):11-19. doi: 10.1590/1984-0462/;2019;37;1;00006. Epub 2018 Jun 11.
PubMed 29898009Failo A, Beals-Erickson SE, Venuti P. Coping strategies and emotional well-being in children with disease-related pain. J Child Health Care. 2018 Mar;22(1):84-96. doi: 10.1177/1367493517749326. Epub 2017 Dec 19.
PubMed 29258354Hermann C, Hohmeister J, Zohsel K, Ebinger F, Flor H. The assessment of pain coping and pain-related cognitions in children and adolescents: current methods and further development. J Pain. 2007 Oct;8(10):802-13. doi: 10.1016/j.jpain.2007.05.010. Epub 2007 Jul 12.
PubMed 17631054
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Turkish Adaptation, Validity, and Reliability Study of the Pain Coping Questionnaire
- ClinicalTrials.gov ID
- NCT05422443
- Acronym / sponsor ID
- 2022-125
- Conditions
- Chronic Pain
- Keywords
- pain, children, coping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 8 Aug 2023 (estimated)
- Study completion
- 12 Aug 2023 (estimated)
- First posted
- 16 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.
Biological, psychological, and social factors all influence a child's sense of pain. Pain beliefs can have a significant impact on a person's perception of pain and adherence to treatment. As a result, pain management requires a thorough examination of the factors that influence pain perception. Coping is a cognitive and behavioral response to conditions and threats based on by personal or environmental factors. Children who do not have adequate coping mechanisms suffer from more severe pain. As a result, dealing with pain is a crucial part of pain management. This highlights the need of assessing pain coping in children when treating chronic pain. The purpose of this study is to show that the Turkish version of the Pain Coping Questionnaire (PCQ), which assesses children's pain coping techniques, is valid and reliable, as well as to ensure that it is culturally appropriate.
Detailed description
Pain is a biopsychosocial term that comprises sensory, cognitive, and emotional factors. The biological, psychological, and cognitive aspects of pain are all present. Pain symptoms and comorbid symptoms are biological characteristics; anxiety, depression, and rage are psychological characteristics; and the ability to cope, catastrophize, and manage pain are cognitive characteristics. As a result, pain is influenced by a person's past experiences and beliefs. Pain that lasts longer than three months is referred to as chronic pain. A major issue is the high prevalence of chronic pain in children. Children with chronic pain have a lower quality of life than their healthy peers. Furthermore, this effect is unrelated to the degree of biological damage. Some children are more sensitive to pain than others, regardless of the severity of the condition. Because psychological, cognitive, and social variables influence an individual's perception of pain in addition to biological tissue damage.
The use of coping techniques in children varies based on the diagnosis, age, and gender of the child, according to the literature. Inadequate coping techniques are linked to a lower quality of life and increased pain severity. As a result, pain assessment in children with chronic pain should be done within a biopsychosocial framework. Various assessments have been developed to assess children's pain tolerating abilities. The Pain Coping Questionnaire (PCQ) was created to evaluate problem-focused, emotional-focused, and avoidance-focused coping strategies in children. It's the most commonly used scale for assessing children's coping techniques. The purpose of this study is to show that the Turkish version of the Pain Coping Questionnaire is valid and reliable (PCQ).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic pain group | – | –Children with chronic pain |
| Health group | – | –children without chronic pain |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children are diagnosed with chronic pain and their parents Children without chronic pain and their parents
Key inclusion criteria (7 listed)
- Age between 6 years and 18 years;
- Diagnosed with chronic pain.
- To have the cognitive ability to answer questions for assessment.
- Completing the test-retest assessment.
- To be able to read and speak Turkish
Key exclusion criteria (5 listed)
- Patients with unmanageable psychological disorders (e.g., attention deficit hyperactivity disorder, autistic spectrum disorder, schizophrenia, bipolar disorder, major depressive disorder) would be excluded from the study.
- Patients who started a new treatment during the trial or 6 weeks before to the study for chronic pain.
- Those who take analgesics 48 hours prior to study evaluations
- Children got medical treatment for a neuropsychiatric disorder
- Children whose parents or themselves refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of coping strategies
Time frame: Baseline
Pain Coping Questionnaire: Evaluates the coping strategies of children and adolescents with a total of 39 items in 8 subscale. These are seeking knowledge, problem solving, seeking social support, positive self-suggestion, behavioral distraction, cognitive distraction, externalization, and internalization/catastrophizing. Items are assessed on a 5-point Likert scale, with 1 indicating never and 5 indicating very often. Higher ratings indicate higher use of coping strategy. PCQ consists of parent and adolescent form.
Evaluation of pain
Time frame: Baseline
Wong baker faces pain scale: It is a valid and reliable scale preferred by children and their families to evaluate the severity of pain. It consists of 6 facial expressions that symbolize the severity of pain. These show the stages of increased pain from a smiling face (0 points) to a very sad and crying face (10 points). The meaning of each facial expression is carefully explained to the child. Children rate pain intensity according to face shapes.
1 secondary outcome
Evaluation of pain acceptance
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Results publication: PubMed 27940762Liossi C, Howard RF. Pediatric Chronic Pain: Biopsychosocial Assessment and Formulation. Pediatrics. 2016 Nov;138(5):e20160331. doi: 10.1542/peds.2016-0331. Epub 2016 Oct 14.
- Results publication: PubMed 25844555Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available.
- Results publication: PubMed 18088558Huguet A, Miro J. The severity of chronic pediatric pain: an epidemiological study. J Pain. 2008 Mar;9(3):226-36. doi: 10.1016/j.jpain.2007.10.015. Epub 2007 Dec 21.
- Results publication: PubMed 29898009Fraga MM, Terreri MT, Azevedo RT, Hilario MOE, Len CA. PAIN PERCEPTION AND PAIN COPING MECHANISMS IN CHILDREN AND ADOLESCENTS WITH JUVENILE FIBROMYALGIA AND POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS. Rev Paul Pediatr. 2019 Jan-Mar;37(1):11-19. doi: 10.1590/1984-0462/;2019;37;1;00006. Epub 2018 Jun 11.
- Results publication: PubMed 29258354Failo A, Beals-Erickson SE, Venuti P. Coping strategies and emotional well-being in children with disease-related pain. J Child Health Care. 2018 Mar;22(1):84-96. doi: 10.1177/1367493517749326. Epub 2017 Dec 19.
- Results publication: PubMed 17631054Hermann C, Hohmeister J, Zohsel K, Ebinger F, Flor H. The assessment of pain coping and pain-related cognitions in children and adolescents: current methods and further development. J Pain. 2007 Oct;8(10):802-13. doi: 10.1016/j.jpain.2007.05.010. Epub 2007 Jul 12.
- Individual participant dataSharing planned: No. The study result will be published to the journal
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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.
Ozgun Kaya Kara, Assoc. Prof. study director
Akdeniz 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 Akdeniz 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Jun 2023. 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?
Results are not available in the source record.
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?
Evaluation of coping strategies (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT05422443, which also lists 6 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 1 Jun 2023.