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Not yet recruiting NCT06638437

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

No phase Interventional Chronic Postsurgical Pain Chronic Post-surgical Pain Chronic Postoperative Pain Chronic Post-operative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive-behavioral therapy.
Who it may be relevant to
Registry conditions: Chronic Postsurgical Pain, Chronic Post-surgical Pain, Chronic Postoperative Pain, Chronic Post-operative Pain. Basic parameters: 8 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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

Primary outcome measures

  • Pain intensity (pre and postsurgical) [Time frame: Baseline (pre); daily for 15 days post-surgery; at 3 and 6 months follow-up]
  • Pain interference (pre and postsurgical) [Time frame: Baseline (pre), and at 3 and 6 months after surgery (post)]
Secondary outcome measures (7)
  • Change in quality of life [Time frame: Baseline (pre) and 3 and 6 months follow-up]
  • Change in functional disability [Time frame: Baseline (pre) and 3 and 6 months follow-up]
  • Change in anxiety and depressive symptoms [Time frame: Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up]
  • Change in pain beliefs [Time frame: Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up]
  • Change in pain catastrophizing [Time frame: Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up]
  • Change in pain coping [Time frame: Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up]
  • Change in sleep quality [Time frame: Baseline (pre); before surgery and after the CBT (pre), daily for 15 days post-surgery; at 3 and 6 months follow-up]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Spain · 3 centers
  • Hospital Universitari Vall d'Hebron — Barcelona
  • Hospital Universitario 12 de octubre — Madrid
  • Hospital Joan XXIII — Tarragona

Identifiers

NCT: NCT06638437 · PID2020-113869RA-I00 · PID2020-113869RA-I00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗