NCT06638437

Prevention of Postsurgical Chronic Pain in Children and Adolescents (PREVENDOL)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: University Rovira i Virgili · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Postsurgical Pain
• Chronic Post-surgical Pain
• Chronic Postoperative Pain
• Chronic Post-operative Pain

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive-behavioral therapy	The mobile application will include the following modules: 1. Psychoeducation: information about what to expect from each phase of the surgical process (i.e., pre-operative, the surgery itself and the post-operative). 2. Activation control techniques: to teach different activation control techniques such as relaxation, breathing techniques and mindfulness training. 3. Cognitive restructuring and problem solving: to teach how to change maladaptive pain-related beliefs for more adaptive ones and how to better cope with pain. 4. Exercises and tasks: to encourage the use of the learning strategies we will offer a number of exercises and tasks 5. Parent's module: to teach parents about the surgical process and how they can help their children during the process

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-10-15
• Last updated: 2024-10-16

Locations

3 sites across 1 country: Spain