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Development and Clinimetric Properties of the Dutch Pediatric Neurophysiology of Pain Questionnaire in Healthy Children

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ClinicalTrials.gov Identifier: NCT03162835
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
Roselien Pas, Vrije Universiteit Brussel

Brief Summary:

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

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 111 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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

Group/Cohort Intervention/treatment
Educated group
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.

Non-educated group
Children within this group will not receive Pain Neuroscience Education



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy children will be recruited via announcements in several schools. Children will be eligible for study participation if they meet the inclusion and exclusion criteria.
Criteria

Inclusion Criteria:

  1. Healthy children
  2. Informed consent

Exclusion Criteria:

  1. Previous pain education
  2. Chronic pain
  3. Insufficient knowledge of the Dutch language
  4. Mental retardation
  5. Parent with chronic pain

Information from the National Library of Medicine

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


Locations
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Belgium
Vrije Universiteit Brussel
Brussels, Jette, Belgium, 1090
Sponsors and Collaborators
Vrije Universiteit Brussel
Universiteit Antwerpen
Investigators
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Principal Investigator: Roselien Pas, Dra Vrije Universiteit Brussel

Publications:

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Responsible Party: Roselien Pas, Dra. Roselien Pas, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT03162835     History of Changes
Other Study ID Numbers: Eduvalid Study (Part 1)
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roselien Pas, Vrije Universiteit Brussel:
Pain Neuroscience Education