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

NCT06638437 | Not Yet Recruiting

• 1 other identifier: PID2020-113869RA-I00
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Post-surgical Pain; Chronic Post-operative Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (2)

CBT group

EXPERIMENTAL

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

Behavioral: Cognitive-behavioral therapy

Control group

NO INTERVENTION

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

Interventions

Cognitive-behavioral therapy BEHAVIORAL

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

CBT group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Having to undergo surgery
• Being between 8 and 18 years old;
• Having signed the informed consent
• Having an ASA risk between I and III

You may not qualify if:

• 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

Sponsors & Collaborators

• University Rovira i Virgili: lead
• Ministerio de Ciencia e Innovación, Spain: collaborator

Study Sites (3)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de octubre

Madrid, 28041, Spain

Location

Hospital Joan XXIII

Tarragona, 43005, Spain

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Elisabet Sánchez-Rodríguez, Dr.

  University Rovira i Virgili

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabet Sánchez-Rodríguez, Dr.

CONTACT

+34 977558141; elisabet.sanchez@urv.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)