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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

Tracking Information
First Submitted Date May 17, 2017
First Posted Date May 22, 2017
Last Update Posted Date October 11, 2018
Actual Study Start Date June 12, 2017
Actual Primary Completion Date September 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 17, 2017)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Development and Clinimetric Properties of the Dutch Pediatric Neurophysiology of Pain Questionnaire in Healthy Children
Official Title Development and Clinimetric Properties of the Dutch Pediatric Neurophysiology of Pain Questionnaire in Healthy Children
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.

Detailed Description

Pain is a common and daily experience among children that is usually short-term, causing little to moderate discomfort. Yet, a substantial number of children experience chronic pain. Persistent pain periods mainly affect the children's school attendance and participation in recreational activities, possibly leading to academic impairments and social exclusion. Even worse is the children's greater predisposition to develop chronic pain into adulthood. Considering these disadvantages, children suffering from chronic pain should be treated as fast as possible and in the most optimal way. The existing literature on management in children with chronic pain encourages a multidisciplinary approach involving physical therapy and psychological interventions (i.e. cognitive behavioural therapy).

Recently, the application of Pain Neuroscience Education (PNE) as an intervention on its own, as well as in combination with another form of therapy (such as physiotherapy or cognitive- behavioural therapy) is receiving growing interest in the pediatric field of chronic pain. PNE aims to make people understand how their pain is produced and enables them to integrate this understanding into their everyday lives and subsequent treatment components. This innovative education style has shown to be effective in various adult chronic pain populations, by improving the patients' pain coping strategies and health status, and changing their pain beliefs. Although, no study examined the effectiveness of PNE in the context of chronic pediatric pain. The hypothetical efficacy of pediatric PNE is based on previous findings in adult research that a better understanding of the nature of the illness results in improved patient outcomes. When children do not understand the origin of their pain, they might develop irrational beliefs and fears (including catastrophizing) about their pain, sustaining the vicious circle of chronic pain. Indeed, the information and context in which children perceive their pain, has been shown to modulate pain expectations and emotional response to pain. Since research findings showed that even parental beliefs about the aetiology of the child's pain influences the child's pain outcomes, the role of parents as 'pain modulators' might not be underestimated. Therefore, parents should be involved during PNE.

Before and subsequent to providing children and their parents with PNE, it might be interesting to assess their previous knowledge and the change in knowledge about the neurophysiology of pain. To date, this aspect can be evaluated in adults by using the Neurophysiology of Pain Questionnaire (NPQ), a questionnaire developed and published by Moseley et al.. This instrument assesses the patients' reconceptualization of pain, and is validated in English and in Dutch. The questionnaire consists of 19 items and was originally based on examination papers of postgraduate medicine students. Various studies have used the NPQ to evaluated pain-related knowledge in adult chronic pain populations, such as chronic low back pain, chronic fatigue syndrome and chronic whiplash associated disorder. Additionally, previous research suggested the use of the NPQ in a study protocol to evaluate the effectiveness of brief education in the prevention of chronic low-back pain in an at-risk population. Noteworthy, the NPQ is also commonly used in clinical practice as a guideline for clinicians during educational sessions about chronic musculoskeletal pain. Previous research has proven adequate clinimetric properties of the English and Dutch version. One study, using a Rash analysis to evaluate the clinimetric properties of the NPQ in an adult chronic spinal population, found the NPQ to have (1) an acceptable internal consistency to assess individuals, (2) to be effective in targeting the ability of a typical group of chronic pain patients, (3) to be a unidimensional scale and (4) to have good test-retest reliability. Examination of the Dutch version showed fair reliability when retesting occurred within 24 hours, acceptable test-retest reliability and one dimensionality of the questionnaire. To conclude, the NPQ has proven to be a reliable and valid measurement instrument for determining the understanding and knowledge of neurophysiology of pain in adult chronic pain populations and healthcare professionals.

Based on this evidence in adults, it may be valuable to develop and examine the clinimetric properties of a Dutch Pediatric Neurophysiology of Pain Questionnaire (PedNPQ) to determine pain knowledge gaps in children.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Surveys and Questionnaires
  • Child
  • Pain
  • Knowledge
  • Validation
Intervention 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.
Study Groups/Cohorts
  • Educated group
    Children within this group will receive Pain Neuroscience Education.
    Intervention: Other: Pain Neuroscience Education
  • Non-educated group
    Children within this group will not receive Pain Neuroscience Education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 9, 2018)
111
Original Estimated Enrollment
 (submitted: May 17, 2017)
60
Actual Study Completion Date September 22, 2018
Actual Primary Completion Date September 22, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 12 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT03162835
Other Study ID Numbers Eduvalid Study (Part 1)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.
Responsible Party Roselien Pas, Vrije Universiteit Brussel
Study Sponsor Vrije Universiteit Brussel
Collaborators Universiteit Antwerpen
Investigators
Principal Investigator: Roselien Pas, Dra Vrije Universiteit Brussel
PRS Account Vrije Universiteit Brussel
Verification Date October 2018