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.
Having to undergo surgery
Being between 8 and 18 years old;
Having signed the informed consent
Having an ASA risk between I and III
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
Parallel
Cognitive-behavioral therapy
BehavioralThe 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
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.
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.
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
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.
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.
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University Rovira i Virgili
Lead sponsor
Ministerio de Ciencia e Innovación, Spain
Collaborator
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