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Completed

NCT Number: NCT03164343

Pain Neuroscience Education in Healthy Children

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vrije Universiteit Brussel

Brussels, Jette, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy children
  • Informed consent

Exclusion criteria

  • Previous pain education
  • Chronic pain
  • Insufficient knowledge of the Dutch language
  • Mental retardation
  • Parent with chronic pain

Treatment and study plan

Pain Neuroscience Education for children

Device

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Collaborators

  • Universiteit Antwerpen

Registry information

Official study title

Pain Neuroscience Education in Healthy Children: A Pilot Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 23, 2017
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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