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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Post-operative Pain; Chronic Postsurgical Pain; Chronic Post-surgical Pain; Chronic Postoperative Pain
• Intervention / Treatment: Behavioral: Cognitive-behavioral therapy

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

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabet Sánchez-Rodríguez, Dr.; Phone Number: +34 977558141; Email: elisabet.sanchez@urv.cat

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Tarragona, Spain, 43005
    • Hospital Joan XXIII

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT group; The treatment arm will carry out the CBT preventive program before surgery	Behavioral: Cognitive-behavioral therapy; The mobile application will include the following modules: Psychoeducation: information about what to expect from each phase of the surgical process (i.e., pre-operative, the surgery itself and the post-operative).; Activation control techniques: to teach different activation control techniques such as relaxation, breathing techniques and mindfulness training.; 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.; Exercises and tasks: to encourage the use of the learning strategies we will offer a number of exercises and tasks; Parent's module: to teach parents about the surgical process and how they can help their children during the process
No Intervention: Control group; The control arm will not do any preventive program (traditional monitoring)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity (pre and postsurgical)	Pain intensity will be recorded using the 0-10 Numerical Rating Scale, with higher scores indicating greater pain intensity	Baseline (pre); daily for 15 days post-surgery; at 3 and 6 months follow-up
Pain interference (pre and postsurgical)	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.	Baseline (pre), and at 3 and 6 months after surgery (post)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	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.	Baseline (pre) and 3 and 6 months follow-up
Change in functional disability	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	Baseline (pre) and 3 and 6 months follow-up
Change in anxiety and depressive symptoms	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.	Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up
Change in pain catastrophizing	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.	Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up
Change in pain coping	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.	Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up
Change in sleep quality	Sleep quality will be assessed using a 0-10 Numerical Rating Scale, with higher scores indicating better sleep quality	Baseline (pre); before surgery and after the CBT (pre), daily for 15 days post-surgery; at 3 and 6 months follow-up
Change in pain beliefs	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.	Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up

Collaborators and Investigators

• Sponsor: University Rovira i Virgili
• Collaborators: Ministerio de Ciencia e Innovación, Spain
• Investigators: Principal Investigator: Elisabet Sánchez-Rodríguez, Dr., University Rovira i Virgili

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain
• Other Study ID Numbers: PID2020-113869RA-I00 (Other Grant/Funding Number: Ministerio de Ciencia e Innovación)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No