Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PID2020-113869RA-I00 | Other Grant/Funding Number | Ministerio de Ciencia e Innovación |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministerio de Ciencia e Innovación, Spain | OTHER_GOV |
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT group | Experimental | The treatment arm will carry out the CBT preventive program before surgery |
|
| Control group | No Intervention | The control arm will not do any preventive program (traditional monitoring) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-behavioral therapy | Behavioral | The mobile application will include the following modules:
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity (pre and postsurgical) | Pain intensity will be recorded using the 0-10 Numerical Rating Scale, with higher scores indicating greater pain intensity | 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. | Baseline (pre), and at 3 and 6 months after surgery (post) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (pre) and 3 and 6 months follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisabet Sánchez-RodrÃguez, Dr. | Contact | +34 977558141 | elisabet.sanchez@urv.cat |
| Name | Affiliation | Role |
|---|---|---|
| Elisabet Sánchez-RodrÃguez, Dr. | University Rovira i Virgili | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain | |||
| Hospital Universitario 12 de octubre |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 | 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. | 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. | 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. | 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. | 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 | Baseline (pre); before surgery and after the CBT (pre), daily for 15 days post-surgery; at 3 and 6 months follow-up |
| Madrid |
| 28041 |
| Spain |
| Hospital Joan XXIII | Tarragona | 43005 | Spain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |