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

NCT06638437 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2024-10-16

No results posted yet for this study

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 Postsurgical Pain
  • Chronic Post-surgical Pain
  • Chronic Postoperative Pain
  • Chronic Post-operative Pain

Interventions

BEHAVIORAL

Cognitive-behavioral therapy

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

Sponsors & Collaborators

  • Ministerio de Ciencia e Innovación, Spain

    collaborator OTHER_GOV

  • University Rovira i Virgili

    lead OTHER

Principal Investigators

  • Elisabet Sánchez-Rodríguez, Dr. · University Rovira i Virgili

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06638437 on ClinicalTrials.gov