Adolescent Idiopathic Scoliosis
Conditions
Keywords
Pain, Function, Pediatric, Scoliosis, Scoliosis Surgery, Spinal Fusion, Idiopathic Scoliosis, Coping, Coping Skills, Education, Video Intervention, Randomized, Prospective, Satisfaction, Adolescent, Opioid
Brief summary
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.
Interventions
OTHERVideo Intervention
Peri-operative video series focusing on expanded education and coping skills before and after scoliosis surgery for adolescent idiopathic scoliosis
OTHERControl
Routine, Standard-of-Care
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
All clinicians and care providers are blinded to participants randomized group
Intervention model description
Prospective, Randomized Controlled Clinical Trial
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
\- All children ages 11 to 18 years old treated with primary multilevel spinal surgery of any approach
Exclusion criteria
* Non-English speaking * Non-idiopathic scoliosis, such as neuromuscular, congenital or syndromic. * Other comorbidity, including developmental delay. * Any surgical complication that results in significant divergence from our institution's standard scoliosis pathway. * Unplanned admission within 6 weeks of index operation. * Active treatment psychotherapy and/or cognitive behavioral therapy for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Operative Pain | Up to 6-weeks post-operatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes - Global Health | Up to 6-weeks post-operatively | 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. |
| Patient Reported Outcomes - Mobility | Up to 6-weeks post-operatively | 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. |
| Patient Reported Outcomes - Physical Activity | Up to 6-weeks post-operatively | 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. |
| Patient Reported Outcomes - Strength Impact | Up to 6-weeks post-operatively | 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. |
| Patient Reported Outcomes - Positive Affect | Up to 6-weeks post-operatively | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain-Related Disability and Post-Operative Functional Status. | Up to 6-weeks post-operatively | 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. |
Countries
United States
Outcome results
None listed