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

NCT07632833 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-30

No results posted yet for this study

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

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-10
Primary Completion
2027-09-30
Completion
2028-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07632833 on ClinicalTrials.gov