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The Use of a Comfort Tote to Improve Recovery in Pediatric and Adolescent Patients After Surgery

The Use of the Comfort Tote Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis: a Randomized Controlled Trial Pilot Study

Who can join

Ages 12 to 21 · All sexes

Inclusion Criteria:

* Patients of all genders, racial, and ethnic groups aged between 10 and 21 that have had been diagnosed with AIS requiring surgical correction with PSF.
* Patients must be scheduled to undergo PSF at Morgan Stanley Children's Hospital of NYP.
* The patients and their parent(s)/legal guardian(s) must also provide informed consent, for those under 18 years old.
* The patient population will include mental health conditions such as anxiety and/or depression and all surgery levels.

Exclusion Criteria:

* Patients who have had growing rods and revisions, those who have local or systemic infections, those with anemia, cardiovascular diseases, or osteoporosis, and patients with severe medical comorbidities such as neurological or developmental condition that precludes engagement with the Comfort Tote
* Patients with two or more chronic conditions (excluding AIS)

About the study

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.

What is being tested

• The Therapeutic Comfort Tote (other)
• The Modified Comfort Tote (other)

Sponsor: Columbia University · Participants: 50 · Started: 2026-12

Contact the study team

• Mirna Giordano · Phone: 917664260

Official record on ClinicalTrials.gov — NCT07632833

Locations in the U.S.

Conditions

• Pain After Surgery
• Postoperative Nausea and Vomiting
• Anxiety

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.