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

NCT07632833 | Not Yet Recruiting

• 1 other identifier: ACYY0676
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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. 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. 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

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

Keywords

Posterior spinal fusion; Integrative therapy

Outcome Measures

Primary Outcomes (5)

• Primary Outcome: Pain

  Impact of each item used in the Comfort Tote on post-operative pain. This will be assessed through a Qualtrics survey across a scale ranging from did not help at all, helped a little, or helped a lot. The number of participants who responded to each of the three options will be reported. Every patient will be linked to a respective page to receive a Qualtrics survey, and this link will be texted/emailed to them.

  From surgery date up to four weeks after surgery

• Primary Outcome: Stress

  Impact of each item used in the Comfort Tote on post-operative stress. This will be assessed through a Qualtrics survey across a scale ranging from did not help at all, helped a little, or helped a lot. The number of participants who responded to each of the three options will be reported. Every patient will be linked to a respective page to receive a Qualtrics survey, and this link will be texted/emailed to them.

  From surgery date up to four weeks after surgery

• Primary Outcome: Anxiety

  Impact of each item used in the Comfort Tote on post-operative anxiety. This will be assessed through a Qualtrics survey across a scale ranging from did not help at all, helped a little, or helped a lot. The number of participants who responded to each of three options will be reported. Every patient will be linked to a respective page to receive a Qualtrics survey, and this link will be texted/emailed to them.

  From surgery date up to four weeks after surgery

• Primary Outcome: Patient Pain scores

  General patient pain scores will be evaluated through measures in EPIC, including Numeric Rating Scale (NRS) pain scores (0-10, 0 being no pain, and 10 being the most severe pain experienced).

  From surgery date up to four weeks after surgery

• Primary Outcome: Caregiver's impression

  Caregivers will also receive a Qualtrics survey to understand their experiences with the Comfort Tote, which will be texted/emailed to them. The scale will include a range of responses from did not help, to help a little, to help a lot. The number of participants who responded to each of the three options will be reported.

  From surgery date up to four weeks after surgery

Secondary Outcomes (12)

• Secondary Outcomes: Tote items usage

  From surgery date up to four weeks after surgery

• Length of stay

  From surgery date until discharge date, assessed up to four weeks after surgery

• ICU LOS

  From surgery date until discharge date, assessed up to four weeks after surgery

• Total direct cost

  From surgery date until discharge date, assessed up to four weeks after surgery

• MME use during hospital admission

  From surgery date until discharge date, assessed up to four weeks after surgery

Study Arms (2)

Therapeutic Comfort Tote

ACTIVE COMPARATOR

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

Other: The Therapeutic Comfort Tote

Modified Comfort Tote

PLACEBO COMPARATOR

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

Other: The Modified Comfort Tote

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.

Therapeutic Comfort Tote

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.

Modified Comfort Tote

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Anxiety Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients and family will not know if the Comfort Tote they receive upon randomization is therapeutic or modified.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Pediatrics

Model Details: Randomization: Following baseline data collection, patients will be randomly assigned in equal numbers to either Group A (receiving the therapeutic Comfort Tote) or Group B (receiving the non-therapeutic Comfort Tote), with 25 patients in each group. Randomization will be stratified by age (12-17, 18-21), legal sex (male, female), and spine level (1-5, 6-10, 11+). The randomization lists will be computer-generated in advance by our biostatistics team.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06