Overview
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.
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.
Eligibility
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)
