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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Peri-operative video series focusing on expanded education and coping skills before and after scoliosis surgery for adolescent idiopathic scoliosis
Routine, Standard-of-Care
University of California, San Francisco
San Francisco, California, United States
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.
Time frame: 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.
Time frame: Up to 6-weeks post-operatively
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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6-weeks post-operatively