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

Starting soon · Not applicable

Conditions studied: Adolescent Idiopathic Scoliosis, Postoperative Pain, Acute, Postoperative Nausea and Vomiting, Anxiety

In brief

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.

Key facts

Study ID: NCT07632833
Run by: Columbia University
People needed: 50
Starts: 2026-08-10
Expected to finish: 2028-06-30
Last updated by the study team: 2026-07-30

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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)

Full record on ClinicalTrials.gov

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