Prevention of Postsurgical Chronic Pain in Children and Adolescents (PREVENDOL)
- Conditions
- Chronic Postsurgical PainChronic Post-surgical PainChronic Postoperative PainChronic Post-operative Pain
- Registration Number
- NCT06638437
- Lead Sponsor
- University Rovira i Virgili
- Brief Summary
Chronic postsurgical pain is a health problem with a great societal impact: approximately 20% of all children and adolescents undergoing surgery will develop chronic pain. Importantly, the risk and protective factors that are known (e.g., anxiety, catastrophizing, pain beliefs and pain coping) are modifiable, thus there is a huge potential for the development of both preventive and protective programs to avoid the transition from acute to chronic pain or reduce the impact in the lives of patients when it has already developed.
- Detailed Description
The main objective of this project is to develop and test a program to prevent the development of chronic postsurgical pain in children and adolescents undergoing surgery in order to improve their quality of life (and that of their families). That program will be implemented in a mobile application.
This proposal will be implemented in 3 phases:
1. Development of the preventive program of chronic postsurgical pain and its implementation in a mobile application
2. Usability test of the mobile application
3. Clinical trial to test the effectiveness of the preventive program
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 125
- Having to undergo surgery
- Being between 8 and 18 years old;
- Having signed the informed consent
- Having an ASA risk between I and III
- Not being able to understand Spanish
- Having a physical and/or cognitive impairment that interferes with understanding the instructions and handling of the application (e.g., moderate to severe intellectual disability, blindness)
- Participating in another clinical trial
- Undergoing an urgent surgical intervention
- Being hospitalized in intensive care due to the need for ventilation or hemodynamic support or other complications
- Having an ASA risk of IV
- Not having signed the informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain intensity (pre and postsurgical) Baseline (pre); daily for 15 days post-surgery; at 3 and 6 months follow-up Pain intensity will be recorded using the 0-10 Numerical Rating Scale, with higher scores indicating greater pain intensity
Pain interference (pre and postsurgical) Baseline (pre), and at 3 and 6 months after surgery (post) Pain intensity will be recorded using the 8-item PROMIS Pediatric Pain Interference Scale, with higher scores indicating greater pain interference. PROMIS measures are scored as T-scores, with a mean of 50 points and an SD of 10.
- Secondary Outcome Measures
Name Time Method Change in quality of life Baseline (pre) and 3 and 6 months follow-up Quality of life will be recorded using the Pediatric Quality of Life Inventory (Peds-QL). It has four scales: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores range between 0 and 100, with higher scores indicating better quality of life.
Change in functional disability Baseline (pre) and 3 and 6 months follow-up Functional disability will be assessed using the Functional Disability Inventory (FDI). The total FDI score can range from 0 to 60, with higher scores indicating higher levels of disability
Change in anxiety and depressive symptoms Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up Anxiety and Depressive Symptoms will be recorded using a 4-item PROMIS Pediatric Anxiety Symptoms and a 4-item PROMIS Pediatric Depressive Symptoms, with higher scores indicating greater pain interference. PROMIS measures are scored as T-scores, with a mean of 50 points and an SD of 10.
Change in pain beliefs Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up Pain beliefs will be assessed using the 35-item Pediatric version of Survey of Pain Attitudes. This questionnaire comprises 7 subscales: Medical cure, Medication, Disability, Emotion, Solicitousness, Control and Exercise. Respondents are asked to report the level of agreement with each item/belief statement on a 3-point Likert scale where 0 means "I do not agree with this", 1 "I am not sure" and 2 "I agree with this". Higher scores in each scale indicate greater confidence in that pain belief.
Change in pain catastrophizing Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up Pain catastrophizing will be assessed using the Pain Catastrophizing Scale for Children (PCS-C). Total scores range from 0 to 52, with higher scores indicating greater pain catastrophizing.
Change in pain coping Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up Pain coping strategies will be assessed using the 14-item Pain Coping Questionnaire (PCQ). The PCQ has 7 scales: Information Seeking \& Problem Solving, Seeking Social Support, Positive Self-Statements, Behavioral Distraction, Cognitive Distraction, Externalizing, and Internalizing/Catastrophizing. Participants are asked to rate how often they use each pain coping response when they are in pain using a 5-point Likert scale (from 1= "Never" to 5 = "Very often") with higher scores indicating greater use of this pain coping strategy.
Change in sleep quality Baseline (pre); before surgery and after the CBT (pre), daily for 15 days post-surgery; at 3 and 6 months follow-up Sleep quality will be assessed using a 0-10 Numerical Rating Scale, with higher scores indicating better sleep quality
Trial Locations
- Locations (3)
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario 12 de octubre
🇪🇸Madrid, Spain
Hospital Joan XXIII
🇪🇸Tarragona, Spain