Recruiting

Comfort Tote

Sponsor:

Columbia University

Code:

NCT07632833

Conditions

Adolescent Idiopathic Scoliosis

Postoperative Pain, Acute

Postoperative Nausea and Vomiting

Anxiety

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Not accepted

Interventions

The Therapeutic Comfort Tote

The Modified Comfort Tote

Study Details

Brief summary:

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.

Conditions

Adolescent Idiopathic Scoliosis

Postoperative Pain, Acute

Postoperative Nausea and Vomiting

Anxiety

Study ID

NCT07632833

Start date

Dec, 2026

Status verified date

Oct, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Therapeutic Comfort Tote

Participants will be randomly assigned to receive the Therapeutic Comfort Tote.

placebo comparator: Modified Comfort Tote

Participants will be randomly assigned to receive the Modified Comfort Tote.

Interventions

The Therapeutic Comfort Tote

The therapeutic Comfort Tote will contain the following items: aromatherapy kit including two essential oils: Balance and Clear, a firm and soft stress ball, five acupressure points including a plasticized map, Mindful Breathing, ImaginAction, EFT/Tapping, and a journal with prompts and coloring pencils included. The patients will also receive written instructions and watch an educational video outlining the contents of the tote and how to use each item.

The Modified Comfort Tote

The non-therapeutic Comfort Tote will contain the following items: journal, coloring book, coloring pencils/markers, stuffed animal, non-scented hand lotion, earplugs, sleep eye mask, and fidget spinner/pop-it. This Tote will come with written instructions.

Primary outcome measure

  • Primary Outcome: Pain [ Time Frame: From surgery date up to four weeks after surgery ]
  • Primary Outcome: Stress [ Time Frame: From surgery date up to four weeks after surgery ]
  • Primary Outcome: Anxiety [ Time Frame: From surgery date up to four weeks after surgery ]
  • Primary Outcome: Patient Pain scores [ Time Frame: From surgery date up to four weeks after surgery ]
  • Primary Outcome: Caregiver's impression [ Time Frame: From surgery date up to four weeks after surgery ]

Central Contacts and Locations

Central contacts

Mirna Giordano

917664260mg2267@cumc.columbia.edu

Locations

NewYork Presbyterian Hospital / Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10018

More Information

Sponsor

Columbia University

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • Posterior spinal fusion
  • Integrative therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.