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NCT Number: NCT06638437

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.

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Key information

Conditions

Chronic Postsurgical Pain Chronic Post-operative Pain Chronic Post-surgical Pain Chronic Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebron, Barcelona, Spain

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About this study

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:

  • Development of the preventive program of chronic postsurgical pain and its implementation in a mobile application
  • Usability test of the mobile application
  • Clinical trial to test the effectiveness of the preventive program

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-Behavioral Therapy

Behavioral

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

Primary outcomes

  1. Pain intensity (pre and postsurgical)

    Time frame: Baseline (pre); daily for 15 days post-surgery; at 3 and 6 months follow-up

    Pain intensity will be recorded using the 0-10 Numerical Rating Scale, with higher scores indicating greater pain intensity

  2. Pain interference (pre and postsurgical)

    Time frame: Baseline (pre), and at 3 and 6 months after surgery (post)

    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.

Secondary outcomes

  1. Change in quality of life

    Time frame: Baseline (pre) and 3 and 6 months follow-up

    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.

  2. Change in functional disability

    Time frame: Baseline (pre) and 3 and 6 months follow-up

    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

  3. Change in anxiety and depressive symptoms

    Time frame: Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up

    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.

  4. Change in pain beliefs

    Time frame: Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up

    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.

  5. Change in pain catastrophizing

    Time frame: Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up

    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.

  6. Change in pain coping

    Time frame: Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up

    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.

  7. 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

    Sleep quality will be assessed using a 0-10 Numerical Rating Scale, with higher scores indicating better sleep quality

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabet Sánchez-Rodríguez, Dr.

CONTACT

[email protected]

+34 977558141

Sponsors and collaborators

Lead sponsor

University Rovira i Virgili

Other

Collaborators

  • Ministerio de Ciencia e Innovación, Spain

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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