Chronic HeadacheNCT05414513
The Turkish Fear of Pain Questionnaire
An observational study of Chronic Headache, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Children's chronic pain is a significant condition that affects roughly 25% of children, with approximately 3% of them requiring intense pain therapy. In the adult literature, various scales have been established to assess fear of pain. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Headache
- How many people
- 195 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children with chronic pain at aged 5-18 years and their parents, their health peers without chronic pain and their parents
Who may be able to join
- Being diagnosed with chronic pain. (2) To have the cognitive ability to answer questions for assessment. (3) Completing the test-retest assessment. (4) To be the native language Turkish.
- between the ages of 5-18.
- Not having any psychiatric or neurological diagnosis.
- To be the native language Turkish.
Who cannot join
- Uncontrollable psychological diseases (eg, attention deficit hyperactivity disorder, autism spectrum disorder, schizophrenia, bipolar disorder, major depressive disorder), specific pathologies, will not be included in the study.
- Patients who started a new treatment during the study or 6 weeks before the study.
- Study participants will be instructed not to take analgesics for 48 hours prior to assessments.
- Families and children who did not agree to participate in the study.
- To have received medical treatment for any neuropsychiatric disorder.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Akdeniz University
Antalya
Ozgun KAYA KARA, Assoc. Prof. PhD, ozgunkara@akdeniz.edu.tr
About this study
Official title: The Turkish Adaptation, Validity, and Reliability Study of the Fear of Pain Questionnaire (FOPQ-TR)
Children's chronic pain is a significant condition that affects roughly 25% of children, with approximately 3% of them requiring intense pain therapy. In the adult literature, various scales have been established to assess fear of pain. When these scales are studied, fear of pain has been shown to have a role in adult chronic pain research, but this topic has gotten less attention in pediatric chronic pain research. The Fear of Pain Questionnaire for Children (FOPQ-C) is a questionnaire that addresses this knowledge gap. The purpose of this study is to determine the validity and clinical utility of the Fear of Pain Questionnaire for Children (FOPQ-C) Scale in the Turkish community.
Read the detailed description
Pain is a multidimensional experience that includes sensory, cognitive, emotional, and social factors. The International Association for the Study of Pain defines chronic pain as pain that lasts longer than three months, besides the lack of a clear description. Chronic pain is a critical developmental health issue that can be recurring or persistent, causing significant disruption in everyday life. Children with chronic pain that is continuous or recurrent may be unable to attend school, may withdraw from social activities, and may develop internalizing symptoms as a result of their discomfort. Given these findings, researchers and clinicians must focus on concerns connected to pediatric chronic pain in order to reduce these challenges and develop appropriate methods. Adults are reported to suffer from 19 percent of chronic pain, with two-thirds describing their pain as "persistent" and 50% describing it as "unbearable." Chronic pain has emerged as a significant problem in children, affecting around one out of every four children, while approximately 3% of children require intense pain therapy.
Psychosocial factors interact with physiological processes to influence pain outcomes such as pain perception and impairment, according to the biopsychosocial model of chronic pain. Fear of pain is a psychological mechanism that has been shown to be effective in predicting chronic pain and accompanying disability in adults. When pain-related sensations are viewed as dangerous, fear of pain develops. The Fear Avoidance Model of Pain outlines how fear of pain influences the outcomes of people who are in chronic pain. Many elements of the condition, including experimentally generated pain severity, pain during dental treatment, chronic pain behavior, and pain-related disability, have been linked to fear of pain. Simultaneously, in the Fear Avoidance Model of Pain, if pain is seen as threatening, pain-related fear develops, leading to avoidance. Simultaneously, in the Fear Avoidance Model of Pain, if pain is seen as threatening, pain-related fear develops, leading to avoidance behaviors and hypervigilance. After that, there's incapacity and depression. These negative outcomes aggravate the fear and avoidance loop. While assessing fear of pain is critical, assessing fear of re-injury is more difficult because it can entail movement, physical activity, or a mix of these things. Furthermore, patients frequently do not report or subjectively sense pain, but rather have trouble performing the actions or activities that have been required of them.
In the adult literature, various scales have been established to assess fear of pain. Fear of pain has been shown to have a role in adult chronic pain research, but it has gotten less attention in pediatric chronic pain research. The Fear of Pain Questionnaire for children and parents (FOPQ-C SF, FOPQ-P) is a questionnaire that addresses this knowledge gap. As a result, the purpose of this study is to see if the Fear of Pain Questionnaire for Children \& Parents (FOPQ-C, FOPQ-P) Scale is valid in the Turkish community and how effective it is in therapeutic practice.
- Conditions
- Chronic Headache
- Keywords
- Chronic headache, Pain related fear, Assessment, Children, validity, cultural adaptation
- Medical subject headings
- Headache Disorders
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 Headache Group | Children with chronic headache | |
| Healthy Group | Children without pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain of fear for children
The Fear of Pain Questionnaire-Short Form (FOPQ-C-SF) for Children is a 10-item variant of the 24-item Fear of Pain Questionnaire for Children. It uses children's self-reports to assess pain-related anxieties (4 items) and avoidance behaviors (6 items). When I'm in pain, for example, I cancel my plans. When I'm in pain, I'm worried something bad may happen. A 0-4 Likert scale is used for scoring. A score of 0 indicates significant disagreement, while a score of 5 indicates great agreement. The total score is calculated by aggregating the individual item scores. Higher pain-related fear and avoidance behavior are associated with higher scores.
Measured: Baseline
Evaluation of pain of fear for parents
The Fear of Pain Scale for Children-Parent Form (FOPQ-P) is a scale that evaluates children's fear of pain with a parent report. FOPQ-P consists of 23 items. The scale assesses fear of pain in three sub-areas. These are: Fear of Pain (8 items), Avoidance of Activities (10 items), and Avoidance of School (5 items). Scoring is done on a Likert scale of 0-4 points. The parent rates the child's approach to pain that has existed for several hours or throughout the day, from 0 = strongly disagree to 4 = strongly agree.
Measured: Baseline
Secondary outcomes (2)
Evaluation of pain catastrophing for children
The Pain Catastrophing Scale was developed to assess adults' pain-related catastrophizing thoughts. The Pain Catastrophizing Scale-Child (PCS-C) is an adapted version of the Pain Catastrophizing Scale for children. PCS-C evaluates catastrophizing behavior with 13 items: thinking long about pain (4 items), magnifying pain (3 items), and helplessness (6 items). For example, I can't get the pain out of my mind. I'm afraid my pain will get worse. There is nothing I can do to reduce the pain. Scoring is done on a Likert scale of 0-4 points. 0=not at all; 4=extremely The adult version of the Turkish version of the Pain Catastrophizing Scale for families will be used.
Measured: Baseline
Evaluation of pain for children
It is a valid and reliable scale that children and their families prefer to use when determining the level of discomfort. It is made up of six different facial expressions that represent the degree of pain. From a happy face (0 points) to a very sad and crying expression, they show the stages of increasing pain (10 points). Each facial expression's meaning is carefully explained to the child. The severity of pain during facials is rated by children.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 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 (8)Papers the sponsor has linked to this study.
- Other trials for Chronic HeadacheStudies 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
- 195 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
- NCT05414513
- Sponsor's protocol ID
- 2022-128
- 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 results are going to publish the journal
Publications
Palermo TM, Chambers CT. Parent and family factors in pediatric chronic pain and disability: an integrative approach. Pain. 2005 Dec 15;119(1-3):1-4. doi: 10.1016/j.pain.2005.10.027. Epub 2005 Nov 18. No abstract available.
PubMed 16298492Palermo TM. Impact of recurrent and chronic pain on child and family daily functioning: a critical review of the literature. J Dev Behav Pediatr. 2000 Feb;21(1):58-69. doi: 10.1097/00004703-200002000-00011.
PubMed 10706352King S, Chambers CT, Huguet A, MacNevin RC, McGrath PJ, Parker L, MacDonald AJ. The epidemiology of chronic pain in children and adolescents revisited: a systematic review. Pain. 2011 Dec;152(12):2729-2738. doi: 10.1016/j.pain.2011.07.016.
PubMed 22078064Jiao J, Vincent A, Cha SS, Luedtke CA, Kim CH, Oh TH. Physical Trauma and Infection as Precipitating Factors in Patients with Fibromyalgia. Am J Phys Med Rehabil. 2015 Dec;94(12):1075-82. doi: 10.1097/PHM.0000000000000300.
PubMed 25888651Hechler T, Dobe M, Zernikow B. Commentary: A worldwide call for multimodal inpatient treatment for children and adolescents suffering from chronic pain and pain-related disability. J Pediatr Psychol. 2010 Mar;35(2):138-40. doi: 10.1093/jpepsy/jsp066. Epub 2009 Aug 14. No abstract available.
PubMed 19684118Leeuw M, Goossens ME, Linton SJ, Crombez G, Boersma K, Vlaeyen JW. The fear-avoidance model of musculoskeletal pain: current state of scientific evidence. J Behav Med. 2007 Feb;30(1):77-94. doi: 10.1007/s10865-006-9085-0. Epub 2006 Dec 20.
PubMed 17180640Vlaeyen JWS, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000 Apr;85(3):317-332. doi: 10.1016/S0304-3959(99)00242-0.
PubMed 10781906Berniger Romariz JA, Nonnemacher C, Abreu M, Dickel Segabinazi J, Bandeira JS, Beltran G, Souza A, Torres IL, Caumo W. The Fear of Pain Questionnaire: psychometric properties of a Brazilian version for adolescents and its relationship with brain-derived neurotrophic factor (BDNF). J Pain Res. 2019 Aug 7;12:2487-2502. doi: 10.2147/JPR.S199120. eCollection 2019.
PubMed 31496790
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 Fear of Pain Questionnaire (FOPQ-TR)
- ClinicalTrials.gov ID
- NCT05414513
- Acronym / sponsor ID
- 2022-128
- Conditions
- Chronic Headache
- Keywords
- Chronic headache, Pain related fear, Assessment, Children, validity, cultural adaptation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 195 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
- 10 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.
Children's chronic pain is a significant condition that affects roughly 25% of children, with approximately 3% of them requiring intense pain therapy. In the adult literature, various scales have been established to assess fear of pain. When these scales are studied, fear of pain has been shown to have a role in adult chronic pain research, but this topic has gotten less attention in pediatric chronic pain research. The Fear of Pain Questionnaire for Children (FOPQ-C) is a questionnaire that addresses this knowledge gap. The purpose of this study is to determine the validity and clinical utility of the Fear of Pain Questionnaire for Children (FOPQ-C) Scale in the Turkish community.
Detailed description
Pain is a multidimensional experience that includes sensory, cognitive, emotional, and social factors. The International Association for the Study of Pain defines chronic pain as pain that lasts longer than three months, besides the lack of a clear description. Chronic pain is a critical developmental health issue that can be recurring or persistent, causing significant disruption in everyday life. Children with chronic pain that is continuous or recurrent may be unable to attend school, may withdraw from social activities, and may develop internalizing symptoms as a result of their discomfort. Given these findings, researchers and clinicians must focus on concerns connected to pediatric chronic pain in order to reduce these challenges and develop appropriate methods. Adults are reported to suffer from 19 percent of chronic pain, with two-thirds describing their pain as "persistent" and 50% describing it as "unbearable." Chronic pain has emerged as a significant problem in children, affecting around one out of every four children, while approximately 3% of children require intense pain therapy.
Psychosocial factors interact with physiological processes to influence pain outcomes such as pain perception and impairment, according to the biopsychosocial model of chronic pain. Fear of pain is a psychological mechanism that has been shown to be effective in predicting chronic pain and accompanying disability in adults. When pain-related sensations are viewed as dangerous, fear of pain develops. The Fear Avoidance Model of Pain outlines how fear of pain influences the outcomes of people who are in chronic pain. Many elements of the condition, including experimentally generated pain severity, pain during dental treatment, chronic pain behavior, and pain-related disability, have been linked to fear of pain. Simultaneously, in the Fear Avoidance Model of Pain, if pain is seen as threatening, pain-related fear develops, leading to avoidance. Simultaneously, in the Fear Avoidance Model of Pain, if pain is seen as threatening, pain-related fear develops, leading to avoidance behaviors and hypervigilance. After that, there's incapacity and depression. These negative outcomes aggravate the fear and avoidance loop. While assessing fear of pain is critical, assessing fear of re-injury is more difficult because it can entail movement, physical activity, or a mix of these things. Furthermore, patients frequently do not report or subjectively sense pain, but rather have trouble performing the actions or activities that have been required of them.
In the adult literature, various scales have been established to assess fear of pain. Fear of pain has been shown to have a role in adult chronic pain research, but it has gotten less attention in pediatric chronic pain research. The Fear of Pain Questionnaire for children and parents (FOPQ-C SF, FOPQ-P) is a questionnaire that addresses this knowledge gap. As a result, the purpose of this study is to see if the Fear of Pain Questionnaire for Children \& Parents (FOPQ-C, FOPQ-P) Scale is valid in the Turkish community and how effective it is in therapeutic practice.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Headache Group | – | –Children with chronic headache |
| Healthy Group | – | –Children without pain |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children with chronic pain at aged 5-18 years and their parents, their health peers without chronic pain and their parents
Key inclusion criteria (4 listed)
- Being diagnosed with chronic pain. (2) To have the cognitive ability to answer questions for assessment. (3) Completing the test-retest assessment. (4) To be the native language Turkish.
- between the ages of 5-18.
- Not having any psychiatric or neurological diagnosis.
- To be the native language Turkish.
Key exclusion criteria (5 listed)
- Families and children who did not agree to participate in the study.
- To have received medical treatment for any neuropsychiatric disorder.
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 pain of fear for children
Time frame: Baseline
The Fear of Pain Questionnaire-Short Form (FOPQ-C-SF) for Children is a 10-item variant of the 24-item Fear of Pain Questionnaire for Children. It uses children's self-reports to assess pain-related anxieties (4 items) and avoidance behaviors (6 items). When I'm in pain, for example, I cancel my plans. When I'm in pain, I'm worried something bad may happen. A 0-4 Likert scale is used for scoring. A score of 0 indicates significant disagreement, while a score of 5 indicates great agreement. The total score is calculated by aggregating the individual item scores. Higher pain-related fear and avoidance behavior are associated with higher scores.
Evaluation of pain of fear for parents
Time frame: Baseline
The Fear of Pain Scale for Children-Parent Form (FOPQ-P) is a scale that evaluates children's fear of pain with a parent report. FOPQ-P consists of 23 items. The scale assesses fear of pain in three sub-areas. These are: Fear of Pain (8 items), Avoidance of Activities (10 items), and Avoidance of School (5 items). Scoring is done on a Likert scale of 0-4 points. The parent rates the child's approach to pain that has existed for several hours or throughout the day, from 0 = strongly disagree to 4 = strongly agree.
2 secondary outcomes
Evaluation of pain catastrophing for children
Time frame: Baseline
Evaluation of pain for children
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 16298492Palermo TM, Chambers CT. Parent and family factors in pediatric chronic pain and disability: an integrative approach. Pain. 2005 Dec 15;119(1-3):1-4. doi: 10.1016/j.pain.2005.10.027. Epub 2005 Nov 18. No abstract available.
- Results publication: PubMed 10706352Palermo TM. Impact of recurrent and chronic pain on child and family daily functioning: a critical review of the literature. J Dev Behav Pediatr. 2000 Feb;21(1):58-69. doi: 10.1097/00004703-200002000-00011.
- Results publication: PubMed 22078064King S, Chambers CT, Huguet A, MacNevin RC, McGrath PJ, Parker L, MacDonald AJ. The epidemiology of chronic pain in children and adolescents revisited: a systematic review. Pain. 2011 Dec;152(12):2729-2738. doi: 10.1016/j.pain.2011.07.016.
- Results publication: PubMed 25888651Jiao J, Vincent A, Cha SS, Luedtke CA, Kim CH, Oh TH. Physical Trauma and Infection as Precipitating Factors in Patients with Fibromyalgia. Am J Phys Med Rehabil. 2015 Dec;94(12):1075-82. doi: 10.1097/PHM.0000000000000300.
- Results publication: PubMed 19684118Hechler T, Dobe M, Zernikow B. Commentary: A worldwide call for multimodal inpatient treatment for children and adolescents suffering from chronic pain and pain-related disability. J Pediatr Psychol. 2010 Mar;35(2):138-40. doi: 10.1093/jpepsy/jsp066. Epub 2009 Aug 14. No abstract available.
- Results publication: PubMed 17180640Leeuw M, Goossens ME, Linton SJ, Crombez G, Boersma K, Vlaeyen JW. The fear-avoidance model of musculoskeletal pain: current state of scientific evidence. J Behav Med. 2007 Feb;30(1):77-94. doi: 10.1007/s10865-006-9085-0. Epub 2006 Dec 20.
- Results publication: PubMed 10781906Vlaeyen JWS, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000 Apr;85(3):317-332. doi: 10.1016/S0304-3959(99)00242-0.
- Results publication: PubMed 31496790Berniger Romariz JA, Nonnemacher C, Abreu M, Dickel Segabinazi J, Bandeira JS, Beltran G, Souza A, Torres IL, Caumo W. The Fear of Pain Questionnaire: psychometric properties of a Brazilian version for adolescents and its relationship with brain-derived neurotrophic factor (BDNF). J Pain Res. 2019 Aug 7;12:2487-2502. doi: 10.2147/JPR.S199120. eCollection 2019.
- Individual participant dataSharing planned: No. The results are going to publish 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 Headache, 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 4 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?
Contact Ishak Isik, MD (02422494400, etik.kurul.07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pain of fear for children (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 NCT05414513, which also lists 8 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; AzTrials last refreshed its copy on 7 Nov 2026.