Clinical trial NCT05414513: The Turkish Fear of Pain Questionnaire
Official title: The Turkish Adaptation, Validity, and Reliability Study of the Fear of Pain Questionnaire (FOPQ-TR)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Headache
Keywords: Chronic headache
Pain related fear
Assessment
Children
validity
cultural adaptation
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 195
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children with chronic pain at aged 5-18 years and their parents, their health peers without chronic pain and their parents

Brief 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. 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.

Eligibility criteria: Inclusion criteria of children with chronic pain:

(1) 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.

* Exclusion criteria for children with chronic pain:

  1. 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.
  2. Patients who started a new treatment during the study or 6 weeks before the study.
  3. Study participants will be instructed not to take analgesics for 48 hours prior to assessments.

Inclusion criteria for healthy children:

1. between the ages of 5-18.
2. Not having any psychiatric or neurological diagnosis.
3. To be the native language Turkish.

Exclusion criteria for healthy children:

1. Families and children who did not agree to participate in the study.
2. To have received medical treatment for any neuropsychiatric disorder.

Primary outcomes:
measure: Evaluation of pain of fear for children
timeFrame: Baseline
measure: Evaluation of pain of fear for parents
timeFrame: Baseline
Secondary outcomes:
measure: Evaluation of pain catastrophing for children
timeFrame: Baseline
measure: Evaluation of pain for children
timeFrame: Baseline
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Akdeniz University
name: Ozgun Kaya Kara, Assoc. Prof
role: STUDY_DIRECTOR
References:
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citation: Leeuw 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.
citation: Vlaeyen 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.
citation: Berniger 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.