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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Start date: Aug 10, 2026 to Dec 2026 · Primary endpoints: details revised at 1 of 5 entries · Eligibility criteria expanded, about 6 words · 1 more Show 4 more changesShow less
    • Start date: Aug 10, 2026 to Dec 2026
    • Primary endpoints: details revised at 1 of 5 entries
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 3 of 12 entries
  2. Notable Start date: Jun 15, 2026 to Aug 10, 2026 Primary completion date: Sep 15, 2027 to Sep 30, 2027v2 Show 1 more changeShow less
    • Primary completion date: Sep 15, 2027 to Sep 30, 2027
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07632833
Lead Sponsor Columbia University
Conditions Adolescent Idiopathic Scoliosis, Postoperative Pain, Acute, Postoperative Nausea and Vomiting, Anxiety
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov