PainNCT06869369
Pain Neuroscience Education for Middle School Students
A study testing Turkish PNE4Kids in people with Pain and Pediatrics, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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?'. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Pediatrics, Neuroscience Pain Education
- What is being tested?
- Turkish PNE4Kids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 21 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being actively educated at midschool level,
- Having sufficient reading and understanding skills in Turkish.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya National Education Directorate
Kütahya, Kütahya, 43100
About this study
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
- Being tested
- Turkish PNE4Kids
- Keywords
- pain, pediatrics, neuroscience pain education, physical activity, sleep
- Medical subject headings
- Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish PNE4KidsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Other: Turkish PNE4Kids |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: Change from Baseline at 3 months
Secondary outcomes (4)
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.
Measured: 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?
Measured: 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.
Measured: 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.
Measured: Change from Baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Jan 2026
- Primary completion1 May 2026
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Saracoglu, Kutahya Health Sciences University
- Investigators
- Esra AKIN, Ph.D., Principal investigator, Kutahya Health Sciences Universityİnci ARIKAN, Prof. Dr., Principal investigator, Kutahya Health Sciences UniversityKelly ICKMANS, Ph.D., Principal investigator, Vrije Universiteit BrusselsEmma RHEEL, Ph.D., Principal investigator, Vrije Universiteit Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869369
- Sponsor's protocol ID
- Turkish PNE4Kids
- Status last verified
- Jul 2026
- First submitted
- 28 Nov 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39243665Pas 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.
PubMed 29550259
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neuroscience Education for Middle School Students
- ClinicalTrials.gov ID
- NCT06869369
- Acronym / sponsor ID
- Turkish PNE4Kids
- Conditions
- Pain, Pediatrics, Neuroscience Pain Education, Physical Activity
- Keywords
- pain, pediatrics, neuroscience pain education, physical activity, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Turkish PNE4Kids |
| control group | No intervention | – |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Being actively educated at midschool level,
- Having sufficient reading and understanding skills in Turkish.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turkish PNE4KidsParticipants 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. | Other | intervention group |
Primary outcome
Physical Activity Level
Time frame: Change from Baseline at 3 months
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.
Sleep Quality
Time frame: Change from Baseline at 3 months
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'.
Pain conceptualization/knowledge level
Time frame: Change from Baseline at 3 months
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.
Leisure Time/Activity Participation
Time frame: Change from Baseline at 3 months
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.
4 secondary outcomes
School attandence level
Time frame: Change from Baseline at 3 months
Physical education class attendance level
Time frame: Change from Baseline at 3 months
Doctor/hospital visits
Time frame: Change from Baseline at 3 months
Using of pain killers
Time frame: Change from Baseline at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Results publication: PubMed 39243665Kara 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.
- Results publication: PubMed 29550259Pas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra AKIN, Ph.D. principal investigator
Kutahya Health Sciences University
İnci ARIKAN, Prof. Dr. principal investigator
Kutahya Health Sciences University
Kelly ICKMANS, Ph.D. principal investigator
Vrije Universiteit Brussels
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turkish PNE4Kids in people with Pain and Pediatrics, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Level (time frame: Change from Baseline at 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06869369, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.