Clinical trial NCT06869369: Pain Neuroscience Education for Middle School Students
Official title: Pain Neuroscience Education for Middle School Students
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Pediatrics
Neuroscience Pain Education
Physical Activity
Keywords: pain
pediatrics
neuroscience pain education
physical activity
sleep
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 57
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Physical Activity Level
timeFrame: Change from Baseline at 3 months
measure: Sleep Quality
timeFrame: Change from Baseline at 3 months
measure: Pain conceptualization/knowledge level
timeFrame: Change from Baseline at 3 months
measure: Leisure Time/Activity Participation
timeFrame: Change from Baseline at 3 months
Secondary outcomes:
measure: School attandence level
timeFrame: Change from Baseline at 3 months
measure: Physical education class attendance level
timeFrame: Change from Baseline at 3 months
measure: Doctor/hospital visits
timeFrame: Change from Baseline at 3 months
measure: Using of pain killers
timeFrame: Change from Baseline at 3 months
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya National Education Directorate
Study officials:
affiliation: Kutahya Health Sciences University
name: Esra AKIN, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kutahya Health Sciences University
name: İnci ARIKAN, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vrije Universiteit Brussels
name: Kelly ICKMANS, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vrije Universiteit Brussels
name: Emma RHEEL, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.