An interventional study of Cognitive-behavioral therapy in Chronic Postsurgical Pain, Chronic Post-surgical Pain and Chronic Postoperative Pain, sponsored by University Rovira i Virgili. Not yet recruiting at 3 sites in Spain. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by University Rovira i Virgili · Not applicable, Interventional, and Prevention
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.
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:
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 125 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University Rovira i Virgili is the lead sponsor of 52 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
The treatment arm will carry out the CBT preventive program before surgery
Behavioral: Cognitive-behavioral therapy
The control arm will not do any preventive program (traditional monitoring)
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
Pain intensity (pre and postsurgical)
Pain intensity will be recorded using the 0-10 Numerical Rating Scale, with higher scores indicating greater pain intensity
Time frame: 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.
Time frame: Baseline (pre), and at 3 and 6 months after surgery (post)
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline (pre); before surgery and after the CBT (pre), daily for 15 days post-surgery; at 3 and 6 months follow-up
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University Rovira i Virgili