Prevention of Postsurgical Chronic Pain in Children and Adolescents (PREVENDOL)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Postsurgical Pain
- Sponsor
- University Rovira i Virgili
- Enrollment
- 125
- Locations
- 3
- Primary Endpoint
- Pain intensity (pre and postsurgical)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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
Investigators
Elisabet Sánchez-Rodríguez
Principal Investigator
University Rovira i Virgili
Eligibility Criteria
Inclusion Criteria
- •Having to undergo surgery
- •Being between 8 and 18 years old;
- •Having signed the informed consent
- •Having an ASA risk between I and III
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Pain intensity (pre and postsurgical)
Time Frame: 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)
Time Frame: 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 Outcomes
- Change in quality of life(Baseline (pre) and 3 and 6 months follow-up)
- Change in functional disability(Baseline (pre) and 3 and 6 months follow-up)
- Change in anxiety and depressive symptoms(Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up)
- Change in pain beliefs(Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up)
- Change in pain catastrophizing(Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up)
- Change in pain coping(Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up)
- 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)