Comfort Tote to help recovery after scoliosis surgery in teens

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this single-blind randomized pilot trial, 50 adolescents undergoing posterior spinal fusion for AIS are assigned to a therapeutic Comfort Tote or a non-therapeutic version to see how each affects pain, anxiety, and stress after surgery. The study also evaluates whether an instructional video improves how patients use the tote’s contents. Outcomes include self-reported pain and anxiety scores, as well as medication use (MMEs) and patient satisfaction, collected at the end of the hospital stay. The tote contents differ between arms, with the therapeutic version adding aromatherapy, acupressure tools, mindfulness activities, and guided prompts. The trial will be conducted at NewYork-Presbyterian/Columbia University Irving Medical Center, with preoperative handoff and postoperative assessment.

Why it matters

Who can join: the full rules

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)

Where it's running

• NewYork Presbyterian Hospital / Columbia University Irving Medical Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Mirna Giordano, MD — Columbia University
• Study coordinator: Mirna Giordano
• Email: mg2267@cumc.columbia.edu
• Phone: 917664260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.