The Use of a Comfort Tote to Improve Recovery in Pediatric and Adolescent Patients After Surgery (NCT07632833) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Use of a Comfort Tote to Improve Recovery in Pediatric and Adolescent Patients After Surgery
50 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range
12 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses something called a 'Comfort Tote' to help kids recover after scoliosis surgery — can you explain what that actually involves, and whether it might be a realistic option for my child alongside standard post-op care?
2Since this trial isn't recruiting yet, how long do you think it might be before it opens, and is there anything we can do now to manage post-surgical pain, anxiety, and nausea while we wait to see if my child might be eligible?
3The study is measuring both the child's pain scores and the caregiver's impressions separately — does that mean there's a role for me as a parent or caregiver in how my child's recovery gets assessed, and what would that actually look like day to day?
4Because this is listed as 'Phase NA,' what does that tell us about what's already known — or not yet known — about whether this kind of comfort-focused approach is safe and effective compared to the standard recovery plan after scoliosis surgery?
5If my child doesn't end up participating in this trial, what other strategies are currently available to help manage post-operative anxiety and nausea after adolescent scoliosis surgery that we should already be planning for?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Outcome: Pain
Timeframe: From surgery date up to four weeks after surgery
2
Primary Outcome: Stress
Timeframe: From surgery date up to four weeks after surgery
3
Primary Outcome: Anxiety
Timeframe: From surgery date up to four weeks after surgery
4
Primary Outcome: Patient Pain scores
Timeframe: From surgery date up to four weeks after surgery
5
Primary Outcome: Caregiver's impression
Timeframe: From surgery date up to four weeks after surgery