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

Conditions

• Adolescent Idiopathic Scoliosis
• Anxiety
• Postoperative Nausea and Vomiting
• Postoperative Pain, Acute

Eligibility Criteria

Sex

ALL

Age

12 Years - 21 Years

Healthy Volunteers

Not accepted

Interventions

• The Therapeutic Comfort Tote — OTHER
  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 — OTHER
  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.

Study Details

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.

Key Dates

First listed

Jun 8, 2026

Start date

Dec 31, 2026

Status verified

Oct 2026

Primary completion

Sep 30, 2027

Completion

Jun 30, 2028

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

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.

Primary Outcome Measure

Primary Outcome: Pain [ Time Frame: From surgery date up to four weeks after surgery ]

Central Contacts

• Mirna Giordano
  917664260
  [email protected]

Locations (1)

Find similar trials in New York, NY

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