Pain Neuroscience Education for Middle School Students

NCT06869369 | Not Yet Recruiting

• 1 other identifier: Turkish PNE4Kids
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This project was designed as a single-blind, randomised controlled, prospective intervention study. The research question of the project is 'Is pain neuroscience education an effective method to improve various aspects of child health, conceptualise pain and change pain-related behaviours in middle school children?'. In other words, the aim of this project is to investigate whether pain neuroscience education (PNE4Kids) is an effective method for improving various aspects of child health, conceptualising pain and changing pain-related behaviours in middle school children. For this purpose, it is planned to implement PNE4Kids based power point presentation and interactive game training. It is aimed to evaluate children in terms of physical activity level, sleep quality/habits, pain conceptualisation level and participation in leisure time activities. Physical activity levels will be assessed with Actigraph GT3X+ accelerometer device and 'Physical Activity Scale for Older Children'. Sleep quality/ habits will be assessed with Actigraph GT3X+ accelerometer and 'Children's Sleep Habits Scale-short form'. Knowledge of pain conceptualisation will be assessed with the 'Conceptualisation of Pain' scale. Children's level of participation in leisure time activities will be assessed through the participation section/domain of the Participation Environment Measure for Children and Youth (PEM-CY). After the baseline measurements of the individuals included in the study and who volunteered will be completed, they will be randomly assigned to the control or intervention group. Participants in the intervention group will receive 'Turkish PNE4Kids Programme'. Individuals in the control group will not receive any intervention. All evaluations will be repeated before the training, immediately after the training and at the end of the 3rd month after the training.

Conditions

Pain; Pediatrics; Neuroscience Pain Education; Physical Activity

Keywords

pain; pediatrics; neuroscience pain education; physical activity; sleep

Outcome Measures

Primary Outcomes (4)

• Physical Activity Level

  Children's physical activity levels will be assessed with the "Physical Activity Questionnaire for Older Children (PAQ-C 8-14)". The scale is an assessment tool that children can self-administer, developed by Crocker et al (Crocker et al., 1997) for children in the 4th to 8th grades. There is also a form of the same scale developed for adolescents (Kowalski et al., 1997). The physical activity scale developed for older children has a total of 10 items based on a 5-point Likert scale (1 point: lowest, 5 points: highest) that measure children's physical activity levels in the last week.

  Change from Baseline at 3 months

• Sleep Quality

  In order to evaluate children's sleep prices, the Child Sleep Habits Questionnaire-short formulas, which were separated by Owens and colleagues (Owens et al., 2000) in 2000 and comprehensively covering children's sleep quality and sleep conduction, will be used (Owens et al., 2000). The questionnaire, which can be done in Turkish and has been made reliable by Balık et al. (Fis et al., 2011), consists of a total of 33 items. The total score of 41 is accepted as the cut-off point and values above this are evaluated as 'clinically significant sleep disturbance'.

  Change from Baseline at 3 months

• Pain conceptualization/knowledge level

  Children's pain concept (pain knowledge, beliefs and attitudes towards pain) levels will be assessed with the "Pain Conceptualization Scale (COPI)". The Pain Conceptualization Scale is a 14-item scale developed by Pate et al (Pate et al., 2020) to assess children's pain knowledge, beliefs and attitudes towards pain. This scale includes pain-related items based on 7 areas suggested by pediatric pain specialists. Each item is evaluated according to a 5-point Likert Scale ranging from "strongly agree (4 points)" to "strongly disagree (0 points)". Higher scores indicate higher levels of compliance with pain science.

  Change from Baseline at 3 months

• Leisure Time/Activity Participation

  Children's participation in leisure activities will be assessed through the participation section/domain of the Participation Environment Measure for Children and Youth (PEM-CY) (Coster et al., 2011). The participation section in the PEM-CY consists of 10 items for home environments, 5 items for school environments, and 10 items for community environments. This scale will be administered by the children's parents.

  Change from Baseline at 3 months

Secondary Outcomes (4)

• School attandence level

  Change from Baseline at 3 months

• Physical education class attendance level

  Change from Baseline at 3 months

• Doctor/hospital visits

  Change from Baseline at 3 months

• Using of pain killers

  Change from Baseline at 3 months

Study Arms (2)

intervention group

EXPERIMENTAL

Other: Turkish PNE4Kids

control group

NO INTERVENTION

Interventions

Turkish PNE4Kids OTHER

Participants in the intervention group will receive 'Turkish PNE4Kids Programme'. The PNE4Kids program was developed based on the book "Explain pain" by Butler and Moseley and includes an explanation and reassurance on the cause of pain, a brief summary of relevant pain mechanisms, and the integral role of psychosocial and physical factors in precipitating and maintaining pain. This programme has been translated and validated in Turkish children.

intervention group

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Being actively educated at midschool level,
• Having sufficient reading and understanding skills in Turkish.

You may not qualify if:

• Chronic pain (pain in ≥1 anatomic region that persists or recurs for longer than 3 months,
• Chronic illness (e.g. cancer, diabetes, asthma, juvenile rheumatic arthritis),
• Being diagnosed with a specific learning disability,
• Being diagnosed with attention deficit hyperactivity disorder,
• Being diagnosed with autism spectrum disorder,
• Not being willing to participate in the study by oneself or one's parents.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya National Education Directorate

Kütahya, Kütahya, 43100, Turkey (Türkiye)

Location

Related Publications (2)

• Kara OK, Gursen C, Ickmans K, Rheel E, Elma O, Cetin SY, Dogan M, Kutluk MG, Kara K. Enhancing pediatric pain management in Turkey: A modified Delphi study on culturally adapted pain neuroscience education for chronic pain in children. J Pediatr Nurs. 2024 Nov-Dec;79:91-99. doi: 10.1016/j.pedn.2024.09.001. Epub 2024 Sep 7.

  PMID: 39243665 BACKGROUND

• Pas R, Meeus M, Malfliet A, Baert I, Oosterwijck SV, Leysen L, Nijs J, Ickmans K. Development and feasibility testing of a Pain Neuroscience Education program for children with chronic pain: treatment protocol. Braz J Phys Ther. 2018 May-Jun;22(3):248-253. doi: 10.1016/j.bjpt.2018.02.004. Epub 2018 Mar 4.

  PMID: 29550259 BACKGROUND

MeSH Terms

Conditions

Pain; Motor Activity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Esra AKIN, Ph.D.

  Kutahya Health Sciences University

  PRINCIPAL INVESTIGATOR

• İnci ARIKAN, Prof. Dr.

  Kutahya Health Sciences University

  PRINCIPAL INVESTIGATOR

• Kelly ICKMANS, Ph.D.

  Vrije Universiteit Brussels

  PRINCIPAL INVESTIGATOR

• Emma RHEEL, Ph.D.

  Vrije Universiteit Brussels

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ismail SARACOGLU, Assoc. Prof.

CONTACT

00 90 274 265 00 43; fzt.saracoglu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: March 11, 2025
• Study Start: September 1, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)