Clinical trial NCT06638437: Prevention of Postsurgical Chronic Pain in Children and Adolescents (PREVENDOL)
Official title: Prevention of Postsurgical Chronic Pain in Children and Adolescents (PREVENDOL)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Postsurgical Pain
Chronic Post-surgical Pain
Chronic Postoperative Pain
Chronic Post-operative Pain
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
Collaborators: name: Ministerio de Ciencia e Innovación, Spain
First posted: 2024-10-15
Enrollment: 125
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria:

1. Having to undergo surgery
2. Being between 8 and 18 years old;
3. Having signed the informed consent
4. Having an ASA risk between I and III

Exclusion Criteria:

1. Not being able to understand Spanish
2. 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)
3. Participating in another clinical trial
4. Undergoing an urgent surgical intervention
5. Being hospitalized in intensive care due to the need for ventilation or hemodynamic support or other complications
6. Having an ASA risk of IV
7. Not having signed the informed consent

Primary outcomes:
measure: Pain intensity (pre and postsurgical)
timeFrame: Baseline (pre); daily for 15 days post-surgery; at 3 and 6 months follow-up
measure: Pain interference (pre and postsurgical)
timeFrame: Baseline (pre), and at 3 and 6 months after surgery (post)
Secondary outcomes:
measure: Change in quality of life
timeFrame: Baseline (pre) and 3 and 6 months follow-up
measure: Change in functional disability
timeFrame: Baseline (pre) and 3 and 6 months follow-up
measure: Change in anxiety and depressive symptoms
timeFrame: Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up
measure: Change in pain beliefs
timeFrame: Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up
measure: Change in pain catastrophizing
timeFrame: Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up
measure: Change in pain coping
timeFrame: Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up
measure: Change in sleep quality
timeFrame: Baseline (pre); before surgery and after the CBT (pre), daily for 15 days post-surgery; at 3 and 6 months follow-up
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario 12 de octubre
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
Study officials:
affiliation: University Rovira i Virgili
name: Elisabet Sánchez-Rodríguez, Dr.
role: PRINCIPAL_INVESTIGATOR
References: