50 Participants NeededMy employer runs this trial

Comfort Tote for Adolescent Idiopathic Scoliosis

MG
Overseen ByMirna Giordano
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University

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?

MG

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

I am 10 to 21 years old and need surgery for scoliosis.
I am scheduled for PSF surgery at Morgan Stanley Children's Hospital of NYP.
I am under 18 and my parent or guardian has given consent for my participation.
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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

Group I: Therapeutic Comfort ToteActive Control1 Intervention
Group II: Modified Comfort TotePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+