Comfort Tote for Adolescent Idiopathic Scoliosis
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn if the use of Comfort Tote can treat pain and anxiety in adolescents with idiopathic scoliosis undergoing posterior spinal fusion. The study aims to answer two questions:
1. To characterize the effectiveness and determine the impact of integrative therapy interventions of the Comfort Tote use in reducing self-reported pain, anxiety, and stress among pediatric patients with AIS undergoing PSF. By comparing self-reported pain, anxiety, and stress scores, as well as documented Morphine Milligram Equivalents (MMEs) and Numeric Rating Scale (NRS) pain scores, between patients using non-therapeutic and therapeutic Comfort Totes.
2. To evaluate the impact of an educational video on the use of the Comfort Tote. This will assess whether the inclusion of instructional content enhances understanding and application of the Comfort Tote, thereby improving patient outcomes in pain management, anxiety reduction, and overall satisfaction with care. It is hypothesized that the therapeutic Comfort Tote intervention with the educational video will provide the highest patient satisfaction and greater tote usage, with decreased patient pain, stress, and anxiety levels. The findings from this pilot study will provide crucial insights into establishing a new standard of care for pediatric patients undergoing PSF and potentially provide baseline data for use in larger, multicenter randomized controlled trials.
Who Is on the Research Team?
Mirna Giordano, MD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
This trial is for patients aged 10–21 with adolescent idiopathic scoliosis who are scheduled for spinal fusion surgery at Morgan Stanley Children's Hospital. Participants must provide consent (with parent/guardian if under 18). Patients with anxiety or depression can also join.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- The Modified Comfort Tote
- The Therapeutic Comfort Tote
Trial Overview
The study compares two types of Comfort Totes—one standard and one therapeutic, possibly with an educational video—to see which better helps reduce pain, stress, and anxiety after spine surgery in young people.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Participants will be randomly assigned to receive the Therapeutic Comfort Tote.
Participants will be randomly assigned to receive the Modified Comfort Tote.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
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