Adolescent Idiopathic ScoliosisNCT07632833
The Use of a Comfort Tote to Improve Recovery in Pediatric and Adolescent Patients After Surgery
A study testing The Therapeutic Comfort Tote and The Modified Comfort Tote in people with Adolescent Idiopathic Scoliosis and Postoperative Pain, Acute, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Postoperative Pain, Acute, Postoperative Nausea and Vomiting
- What is being tested?
- The Therapeutic Comfort Tote and The Modified Comfort Tote
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to 30 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NewYork Presbyterian Hospital / Columbia University Irving Medical Center
New York, New York, 10018
About this study
Official title: The Use of the Comfort Tote Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis: a Randomized Controlled Trial Pilot Study
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:
- 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.
- 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.
Read the detailed description
The single-blind randomized controlled trial pilot study will include 50 adolescent participants aged 12 to 21, evenly distributed between the two study arms: a non-therapeutic modified Comfort Tote with written instructions and a therapeutic Comfort Tote with written instructions and an educational video. The RCT will be a single-blind study, with patients blinded to the intervention they receive. All totes will be available in English and Spanish, and patients will receive them during the pre-operative visit with the orthopedics team post-randomization. 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. 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 a video outlining the contents of the tote and how to use each item.
Both prospective and retrospective methods will be used. A survey will be delivered at the final, postoperative in-hospital appointment between patients and their surgical team. The survey will evaluate their experience with the Comfort Tote. Primary outcomes include the impact of each Comfort Tote item on post-operative pain, stress, and anxiety scores. These will be assessed through a Qualtrics survey using a scale ranging from "did not help at all" to "helped a little" to "helped a lot". Every patient will be linked to a respective page to receive a Qualtrics survey, and this link will be texted/emailed to them. Caregivers will also receive a Qualtrics survey about their experiences with the Comfort Tote, sent via text or email. General patient pain scores will also be evaluated using measures in EPIC, including the Numeric Rating Scale (NRS).
Secondary outcomes include tote item usage, length of hospital stay (LOS), Intensive Care Unit (ICU) LOS, total direct costs (TDC), morphine milligram equivalents (MME) administered during the hospital stay, opioid prescriptions at discharge, surgical site infections, readmissions or unanticipated return to clinic, and mobility scores through the AM PAC mobility score determined by physical therapy. Tote usage indicates results from patients recording which tote components they used, collected through a post-operative Qualtrics survey. Secondary outcomes will also include whether or not patients took Gabapentin, and patients will receive a calendar with instructions upon discharge to document opioid use at home. Caregivers will also be surveyed at the final postoperative in-hospital appointment to understand their experiences with the Comfort Tote.
Aim 1: Evaluate whether the Comfort Tote intervention leads to greater reductions in self-reported pain, stress, and anxiety among patients diagnosed with adolescent idiopathic scoliosis (AIS) undergoing posterior spinal fusion (PSF).
Aim 2: Assess the effect of the therapeutic Comfort Tote on hospital resource utilization - specifically length of stay, ICU days, and direct costs - as well as opioid exposure, including in-hospital morphine milligram equivalents and opioid prescriptions at discharge. Additionally, this study will examine clinical outcomes, including surgical-site infections, unanticipated readmissions or clinic visits, and discharge mobility, using AM-PAC mobility scores.
Aim 3: Assess patient caregivers' experiences with and perceptions of the Comfort Tote's usefulness using data collected via a brief structured survey.
- Conditions
- Adolescent Idiopathic Scoliosis, Postoperative Pain, Acute, Postoperative Nausea and Vomiting, Anxiety
- Being tested
- The Therapeutic Comfort Tote, The Modified Comfort Tote
- Keywords
- Posterior spinal fusion, Integrative therapy
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Therapeutic Comfort ToteOther
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 ToteOther
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 group | Role | What they receive |
|---|---|---|
| Therapeutic Comfort Tote | Active comparator | Participants will be randomly assigned to receive the Therapeutic Comfort Tote. Receives: Other: The Therapeutic Comfort Tote |
| Modified Comfort Tote | Placebo comparator | Participants will be randomly assigned to receive the Modified Comfort Tote. Receives: Other: The Modified Comfort Tote |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: From surgery date up to four weeks after surgery
Secondary outcomes (12)
Secondary Outcomes: Tote items usage
Secondary outcomes include tote item usage. Tote usage indicates results from patients recording which tote components they used, collected through a post-operative Qualtrics survey. The patients will register if they used the item even once - yes, no, or not sure.
Measured: From surgery date up to four weeks after surgery
Length of stay
Secondary outcomes include length of hospital stay (LOS) in days.
Measured: From surgery date until discharge date, assessed up to four weeks after surgery
ICU LOS
Secondary outcomes include Intensive Care Unit (ICU) LOS in days.
Measured: From surgery date until discharge date, assessed up to four weeks after surgery
Total direct cost
Secondary outcomes include total direct costs (TDC) in dollars.
Measured: From surgery date until discharge date, assessed up to four weeks after surgery
MME use during hospital admission
Secondary outcomes include morphine milligram equivalents (MME) administered during the hospital stay from the EPIC-recorded pain team's notes.
Measured: From surgery date until discharge date, assessed up to four weeks after surgery
Opioid prescriptions at discharge
Secondary outcomes include opioid prescriptions at discharge in total milligrams and milligrams per dose.
Measured: From discharge from hospital until up to four weeks after surgery
Surgical site infections
Secondary outcomes include surgical site infections.
Measured: From surgery date until up to four weeks after surgery
Readmissions
Secondary outcomes include readmissions, defined as hospital admissions within 30 days of discharge.
Measured: Assessed up to 4 weeks after surgery
Unanticipated return to clinic
Secondary outcomes include unanticipated return to clinic.
Measured: Assessed up to 4 weeks after surgery
Mobility Scores
Secondary outcomes include mobility scores via AM PAC mobility scores assigned by physical therapy. Includes six possible scores: 1-Rolling over in bed 2- Sitting up from lying down 3- Sitting down and standing up from a chair 4- Moving from sitting to standing (transfers)5- Walking 6- Climbing stairs
Measured: Assessed up to 4 weeks after surgery
Gabapentin use
Secondary outcomes include whether or not patients took Gabapentin.
Measured: From surgery date until up to four weeks after surgery
Postoperative opioid use at home
Secondary outcomes include postoperative opioid use via a calendar with instructions upon discharge to document opioid use at home.
Measured: From discharge until up to four weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startDec 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirna Giordano, Columbia University
- Investigators
- Mirna Giordano, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632833
- Sponsor's protocol ID
- ACYY0676
- Status last verified
- Oct 2026
- First submitted
- 2 Jun 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No