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

University Rovira i Virgili

Status: Not yet enrolling

Conditions: Chronic Post-operative Pain; Chronic Postoperative Pain; Chronic Post-surgical Pain; Chronic Postsurgical Pain

Treatments: Behavioral: Cognitive-behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06638437

PID2020-113869RA-I00 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 125 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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125 participants in 2 patient groups

CBT group

Experimental group

Description:

The treatment arm will carry out the CBT preventive program before surgery

Treatment:

Behavioral: Cognitive-behavioral therapy

Control group

No Intervention group

Description:

The control arm will not do any preventive program (traditional monitoring)