Chronic Postsurgical PainNCT06638437
Prevention of Postsurgical Chronic Pain in Children and Adolescents (PREVENDOL)
A study testing Cognitive-behavioral therapy in people with Chronic Postsurgical Pain and Chronic Post-surgical Pain, run by University Rovira i Virgili at 3 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Chronic Postsurgical Pain, Chronic Post-surgical Pain, Chronic Postoperative Pain
- What is being tested?
- Cognitive-behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Nov 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Having to undergo surgery
- Being between 8 and 18 years old;
- Having signed the informed consent
- Having an ASA risk between I and III
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario 12 de octubre
Madrid, 28041
Hospital Joan XXIII
Tarragona, 43005
About this study
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.
Read the 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:
- 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
- Conditions
- Chronic Postsurgical Pain, Chronic Post-surgical Pain, Chronic Postoperative Pain, Chronic Post-operative Pain
- Being tested
- Cognitive-behavioral therapy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| CBT group | Experimental | The treatment arm will carry out the CBT preventive program before surgery Receives: Behavioral: Cognitive-behavioral therapy |
| Control group | No intervention | The control arm will not do any preventive program (traditional monitoring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (pre and postsurgical)
Pain intensity will be recorded using the 0-10 Numerical Rating Scale, with higher scores indicating greater pain intensity
Measured: 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.
Measured: Baseline (pre), and at 3 and 6 months after surgery (post)
Secondary outcomes (7)
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.
Measured: 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
Measured: 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.
Measured: Baseline (pre), before surgery and after the CBT (pre), 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline (pre); before surgery and after the CBT (pre), daily for 15 days post-surgery; at 3 and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Postsurgical PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Principal investigator, Elisabet Sánchez-Rodríguez, University Rovira i Virgili
- Investigators
- Elisabet Sánchez-Rodríguez, Dr., Principal investigator, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638437
- Sponsor's protocol ID
- PID2020-113869RA-I00
- Other IDs
- PID2020-113869RA-I00
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No