Pain Neuroscience Education for Middle School Students

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Physical Activity; Pediatrics; Neuroscience Pain Education
• Intervention / Treatment: Other: Turkish PNE4Kids

• Study Type: Interventional
• Enrollment (Estimated): 57
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ismail SARACOGLU, Assoc. Prof.; Phone Number: 1457 00 90 274 265 00 43; Email: fzt.saracoglu@hotmail.com

Study Locations

• Turkey
  • Kutahya, Turkey, 43100
    • Kutahya National Education Directorate
    • Contact: Hasan BASYIGIT, Head of National Education; Phone Number: 1457 (0274) 280 43 00; Email: kutahyamem@meb.gov.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: intervention group	Other: Turkish PNE4Kids; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
School attandence level	Children's school attendance will be evaluated with the "e-school absence tracking" (Golcuk, 2015) system. This information will be requested from the school administration. Beforehand, parents will be contacted by phone and their consent will be obtained with the Personal Data Protection (PDPL) Informed Consent Form.	Change from Baseline at 3 months
Physical education class attendance level	This information will be requested from physical education teachers. Parents will be contacted by phone beforehand and their consent will be obtained with the Personal Data Protection (PDP) Informed Consent Form. Children's attendance to physical education classes will be evaluated by the physical education teacher by answering the following questions: • Has he/she missed physical education classes due to pain in the last 3 months - yes/no; if yes, how many days/lessons?	Change from Baseline at 3 months
Doctor/hospital visits	Information on the frequency of children's doctor visits will be requested from the children's parents. The parents will be contacted by phone and their consent will be obtained with the Informed Consent Form on the Protection of Personal Data (KVK) beforehand. Question 1: How many times have you been to the doctor in the last 3 months because you had pain somewhere?; We never did.; We went once; We went more than once. Question 2: Have you received rehabilitation treatment (physical therapy, exercise, manual therapy, etc.) in the last 3 months because you had pain somewhere?; We never did.; We did once.; We did more than once.	Change from Baseline at 3 months
Using of pain killers	Information on the frequency of children's medication use will be requested from the children's parents. The parents will be contacted by phone and their consent will be obtained with the Informed Consent Form on the Protection of Personal Data (KVK) beforehand. Question 1: How many times have I used medication in the last 3 months because I had pain somewhere?; We never did.; We used once.; We used more than once.	Change from Baseline at 3 months

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: pediatrics; physical activity; pain; sleep; neuroscience pain education
• Other Study ID Numbers: Turkish PNE4Kids

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No