Development and Clinimetric Properties of the Dutch Pediatric Neurophysiology of Pain Questionnaire in Healthy Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03162835|
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : October 11, 2018
The scientific objective of this research implies developing and examining the clinimetric properties of the Dutch Pediatric Neurophysiology of Pain Questionnaire (PedNPQ) in healthy children.
A total study sample of 60 healthy children (30 from 2nd and 3rd primary school) will be included to measure test-retest reliability of the Pediatric Neurophysiology of Pain Questionnaire (PedNPQ). Children will be asked to fill in the questionnaire twice, with a time interval of 48 hours (assessment T0 and T1).
In order to assess concurrent validity of the PedNPQ, 30 children (15 from 2nd and 3rd primary school) as well as their parent will receive a pediatric Pain Neuroscience Education (PNE) session. It is hypothesized that if the developed PedNPQ is valid, children who received PNE will perform better than children receiving no PNE.
To reduce the participant's workload, all assessments will be done immediately after the school hours or during recreation, in the primary school of the participant.
|Condition or disease||Intervention/treatment|
|Surveys and Questionnaires Child Pain Knowledge Validation||Other: Pain Neuroscience Education|
|Study Type :||Observational|
|Actual Enrollment :||111 participants|
|Official Title:||Development and Clinimetric Properties of the Dutch Pediatric Neurophysiology of Pain Questionnaire in Healthy Children|
|Actual Study Start Date :||June 12, 2017|
|Actual Primary Completion Date :||September 22, 2018|
|Actual Study Completion Date :||September 22, 2018|
Children within this group will receive Pain Neuroscience Education.
Other: Pain Neuroscience Education
Children as well as their parents will receive a +/- 1h one-on-one educational session about the neurophysiology of pain, adjusted to the child's comprehension status. Parents will be present in the PNE session too. The PNE program for children contains two sections: (1) The healthy pain system and its function, divided in subsections each consisting of a specific neurophysiological pain concept (i.e. central nervous system anatomy, nociception and nociceptive pathways, up- and down-regulation of the nervous system) and (2) adaptations of the pain system following persistent pain. To ensure interaction between therapist and child, an interactive board game was developed and used throughout the full educational session.
Children within this group will not receive Pain Neuroscience Education
- Reliability of the Pediatric Neurophysiology of Pain Questionnaire (PedNPQ) [ Time Frame: Baseline - 48 hours after baseline ]In order to evaluate test-retest reliability of the test, the two-way mixed infraclass correlation coefficient will be calculated.
- Concurrent validity of the Pediatric Neurophysiology of Pain Questionnaire (PedNPQ) [ Time Frame: immediately after Pain Neuroscience education (PNE) (48 hours following baseline) ]The validity of the test will be assessed by comparing the test results of the children who received PNE with the children who did not receive PNE.
- Responsivity of the Pediatric Neurophysiology of Pain Questionnaire [ Time Frame: Baseline, immediately after Pain Neuroscience education (PNE) and 1 week following PNE ]The responsivity of the test will be assessed by comparing the child's baseline responses to the test with their responses after Pain Neuroscience Education.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162835
|Vrije Universiteit Brussel|
|Brussels, Jette, Belgium, 1090|
|Principal Investigator:||Roselien Pas, Dra||Vrije Universiteit Brussel|