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Pain Neuroscience Education in Healthy Children

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ClinicalTrials.gov Identifier: NCT03164343
Recruitment Status : Completed
First Posted : May 23, 2017
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
Roselien Pas, Vrije Universiteit Brussel

Brief Summary:

The primary objective of this study is to examine whether Pain Neuroscience Education for children is able to increase a child's knowledge on the neurophysiology of pain.

In addition, this study investigates the influence of PNE on several pain related outcomes; pain-related fear, pain catastrophizing and pain vigilance and awareness.


Condition or disease Intervention/treatment Phase
Child Pain Device: Pain Neuroscience Education for children Not Applicable

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.

Concrete, the present study will examine whether reconceptualization of pain, by PNE is able to influence both child and parent knowledge of pain, as well as some other pain-related outcomes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pain Neuroscience Education in Healthy Children: A Pilot Study
Actual Study Start Date : August 8, 2017
Actual Primary Completion Date : September 22, 2018
Actual Study Completion Date : September 22, 2018

Arm Intervention/treatment
Experimental: Pain Neuroscience Education for children
All participants within this study will receive Pain Neuroscience Education
Device: Pain Neuroscience Education for children
Children and their parent 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.




Primary Outcome Measures :
  1. Dutch Pediatric Neurophysiology of Pain Questionnaire (PedNPQ) [ Time Frame: Change from baseline (before PNE) to immediately after PNE and 1 week following PNE ]
    The neurophysiology of pain knowledge of the child and parent will be assessed by using a questionnaire. The Dutch Pediatric Neurophysiology of Pain Questionnaire (PedNPQ) will be used to determine the current knowledge of pain and to evaluate the effect of PNE.

  2. Neurophysiology of Pain Questionnaire (NPQ) [ Time Frame: Change from baseline (before PNE) to immediately after PNE and 1 week following PNE ]
    The parent's knowledge of pain will also be assessed by the Neurophysiology of Pain Questionnaire (NPQ).


Secondary Outcome Measures :
  1. Pain-related fear using the Fear of Pain Questionnaire - Parent version (FOPQ-P) [ Time Frame: Baseline (before PNE) and 1 week following PNE ]
    For parental report, the Fear of Pain Questionnaire - Parent version (FOPQ-P) will be used to assess their own fear and avoidance behavior associated with their child's pain.

  2. Catastrophic thinking about pain using the Dutch version of the Pain Catastrophizing Scale (PCS) [ Time Frame: Baseline (Before PNE) and 1 week following PNE ]

    Catastrophic thinking about pain will be measured using the Dutch version of the Pain Catastrophizing Scale (PCS).

    Parent's catastrophic thinking about their child's pain will be measured using the Dutch version of the Pain Catastrophizing Scale for Parents (PCS-P).


  3. Pain Vigilance and Awareness assessed by the Pain Vigilance and Awareness Questionnaire (PVAQ) [ Time Frame: Baseline (before PNE) and 1 week following PNE ]
    Pain vigilance and awareness of the parent will be assessed by the Pain Vigilance and Awareness Questionnaire (PVAQ).



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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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): NCT03164343


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, MSc Vrije Universiteit Brussel
Publications:

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Responsible Party: Roselien Pas, Principal investigator, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT03164343    
Other Study ID Numbers: Eduvalid Study (Part 2)
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
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