Kutahya National Education Directorate
Kütahya, 43100, Turkey (Türkiye)
NCT Number: NCT06869369
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.
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Notify Me10 year–12 year
All sexes
Interventional
Not applicable
Kütahya, 43100, Turkey (Türkiye)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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'.
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.
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.
Time frame: Change from Baseline at 3 months
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.
Time frame: Change from Baseline at 3 months
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:
Time frame: Change from Baseline at 3 months
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?
Question 2: Have you received rehabilitation treatment (physical therapy, exercise, manual therapy, etc.) in the last 3 months because you had pain somewhere?
Time frame: Change from Baseline at 3 months
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?
Kutahya Health Sciences University
Other
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