Pain Neuroscience Education for Middle School Students

NCT ID: NCT06869369

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

intervention group

Group Type: EXPERIMENTAL

Turkish PNE4Kids

Intervention Type: 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.

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kutahya Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Ismail Saracoglu

Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esra AKIN, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kutahya Health Sciences University

İnci ARIKAN, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Kutahya Health Sciences University

Kelly ICKMANS, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vrije Universiteit Brussels

Emma RHEEL, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vrije Universiteit Brussels

Locations

Kutahya National Education Directorate

Kütahya, Kütahya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Ismail SARACOGLU, Assoc. Prof.

Role: CONTACT

fzt.saracoglu@hotmail.com

00 90 274 265 00 43 ext. 1457

Facility Contacts

Hasan BASYIGIT, Head of National Education

Role: primary

kutahyamem@meb.gov.tr

(0274) 280 43 00 ext. 1457

References

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.

Reference Type: BACKGROUND

PMID: 39243665 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29550259 (View on PubMed)

Other Identifiers

Turkish PNE4Kids

Identifier Type: -

Identifier Source: org_study_id