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This is a prospective, randomized controlled trial evaluating the efficacy of expanded patient education and coping skills on pain management following multilevel pediatric spinal surgery. The intervention will include a smartphone- based platform and a comprehensive library of peri-operative educational and coping skills videos as a means for better addressing the psychosocial elements of a child's individual pain experience. The study evaluated whether this novel intervention will reduce pain, improve outcomes and accelerate functional recovery up to 6 weeks after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Routine, standard-of-care treatment |
|
| Video Intervention | Experimental | Routine, standard-of-care PLUS peri-operative video series |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video Intervention | Other | Peri-operative video series focusing on expanded education and coping skills before and after scoliosis surgery for adolescent idiopathic scoliosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-Operative Pain | Outcome #1 will evaluate the intervention's impact on post-operative pain via completion of the computer-adaptive NIH PROMIS measures on pain intensity and pain behavior. For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference. | Up to 6-weeks post-operatively |
| Post-Operative Pain | Outcome #2 will evaluate the intervention's impact on a proxy for post-operative pain via completion of a 1-question survey on recent opioid consumption. The question is formatted as a 5-point Likert scale, scored 1-5, with higher scores indicating more frequent opioid consumption. | Up to 6-weeks post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcomes - Global Health | Outcome #3 will measure patient reported outcomes via administration of the computer adaptive NIH PROMIS measures for global health. For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores for this measure will be converted to T-scores via the NIH's published guidelines. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain-Related Disability and Post-Operative Functional Status. | Outcome #8 will measure post-operative functional status via a 5-question survey on the following activities: sleeping through the night without awaking for pain medication, walking outside the house, showering and dressing independently, patient return to school and parent return to work. Each of these questions was selected as a proxy for improved functional status. Each question is answered 'Yes' or 'No", and graded '1' or '0', respectively. A higher score represents improved functional status. Each of these questionnaires will be administered on a weekly basis. |
Inclusion criteria:
- All children ages 11 to 18 years old treated with primary multilevel spinal surgery of any approach
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Diab, MD | UCSF Department of Orthopaedic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25439116 | Background | Charette S, Fiola JL, Charest MC, Villeneuve E, Theroux J, Joncas J, Parent S, Le May S. Guided Imagery for Adolescent Post-spinal Fusion Pain Management: A Pilot Study. Pain Manag Nurs. 2015 Jun;16(3):211-20. doi: 10.1016/j.pmn.2014.06.004. Epub 2014 Nov 6. | |
| 14705469 | Background | LaMontagne L, Hepworth JT, Salisbury MH, Cohen F. Effects of coping instruction in reducing young adolescents' pain after major spinal surgery. Orthop Nurs. 2003 Nov-Dec;22(6):398-403. doi: 10.1097/00006416-200311000-00005. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D012600 | Scoliosis |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013121 | Spinal Curvatures |
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Prospective, Randomized Controlled Clinical Trial
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All clinicians and care providers are blinded to participants randomized group
| Control | Other | Routine, Standard-of-Care |
|
| Up to 6-weeks post-operatively |
| Patient Reported Outcomes - Mobility | Outcome #4 will measure patient reported outcomes and functional status via completion of the computer-adaptive NIH PROMIS measure for mobility For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference. | Up to 6-weeks post-operatively |
| Patient Reported Outcomes - Positive Affect | Outcome #5 will measure patient reported outcomes via completion of the computer-adaptive NIH PROMIS measure for positive affect. For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference. | Up to 6-weeks post-operatively |
| Patient Reported Outcomes - Physical Activity | Outcome #6 will measure patient reported outcomes and functional status via completion of the computer-adaptive NIH PROMIS measure for physical activity. For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference. | Up to 6-weeks post-operatively |
| Patient Reported Outcomes - Strength Impact | Outcome #7 will measure patient reported outcomes and functional status via completion of the computer-adaptive NIH PROMIS measure for strength impact. For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference. | Up to 6-weeks post-operatively |
| Up to 6-weeks post-operatively |
| 28232147 | Background | Rabbitts JA, Aaron RV, Fisher E, Lang EA, Bridgwater C, Tai GG, Palermo TM. Long-Term Pain and Recovery After Major Pediatric Surgery: A Qualitative Study With Teens, Parents, and Perioperative Care Providers. J Pain. 2017 Jul;18(7):778-786. doi: 10.1016/j.jpain.2017.02.423. Epub 2017 Feb 21. |
| 25036417 | Background | Rhodes L, Nash C, Moisan A, Scott DC, Barkoh K, Warner WC Jr, Sawyer JR, Kelly DM. Does preoperative orientation and education alleviate anxiety in posterior spinal fusion patients? A prospective, randomized study. J Pediatr Orthop. 2015 Apr-May;35(3):276-9. doi: 10.1097/BPO.0000000000000260. |
| 24173016 | Background | Connelly M, Fulmer RD, Prohaska J, Anson L, Dryer L, Thomas V, Ariagno JE, Price N, Schwend R. Predictors of postoperative pain trajectories in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2014 Feb 1;39(3):E174-81. doi: 10.1097/BRS.0000000000000099. |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001519 | Behavior |