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

RecruitingNAAges 12 Years - 21 YearsAllColumbia University
NCT07632833 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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)
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What it tests

  • The Therapeutic Comfort Tote
  • The Modified Comfort Tote
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Where

1 site
NewYork Presbyterian Hospital / Columbia University Irving Medical Center
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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