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

The single‐blind randomized controlled trial pilot study will include 50 adolescentparticipants aged 12 to 21, evenly distributed between the two study arms: anon‐therapeutic modified Comfort Tote with written instructions and a therapeutic ComfortTote with written instructions and an educational video. The RCT will be a single‐blindstudy, with patients blinded to the intervention they receive. All totes will beavailable in English and Spanish, and patients will receive them during the pre‐operativevisit with the orthopedics team post‐randomization. The non‐therapeutic Comfort Tote willcontain the following items: journal, coloring book, coloring pencils/markers, stuffedanimal, 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 containthe following items: aromatherapy kit including two essential oils: Balance and Clear, afirm and soft stress ball, five acupressure points including a plasticized map, MindfulBreathing, ImaginAction, EFT/Tapping, and a journal with prompts and coloring pencilsincluded. The patients will also receive written instructions and watch a video outliningthe contents of the tote and how to use each item.Both prospective and retrospective methods will be used. A survey will be delivered atthe final, postoperative in‐hospital appointment between patients and their surgicalteam. The survey will evaluate their experience with the Comfort Tote. Primary outcomesinclude the impact of each Comfort Tote item on post‐operative pain, stress, and anxietyscores. These will be assessed through a Qualtrics survey using a scale ranging from "didnot help at all" to "helped a little" to "helped a lot". Every patient will be linked toa respective page to receive a Qualtrics survey, and this link will be texted/emailed tothem. Caregivers will also receive a Qualtrics survey about their experiences with theComfort Tote, sent via text or email. General patient pain scores will also be evaluatedusing measures in EPIC, including the Numeric Rating Scale (NRS).Secondary outcomes include tote item usage, length of hospital stay (LOS), Intensive CareUnit (ICU) LOS, total direct costs (TDC), morphine milligram equivalents (MME)administered during the hospital stay, opioid prescriptions at discharge, surgical siteinfections, readmissions or unanticipated return to clinic, and mobility scores throughthe AM PAC mobility score determined by physical therapy. Tote usage indicates resultsfrom patients recording which tote components they used, collected through apost‐operative Qualtrics survey. Secondary outcomes will also include whether or notpatients took Gabapentin, and patients will receive a calendar with instructions upondischarge to document opioid use at home. Caregivers will also be surveyed at the finalpostoperative in‐hospital appointment to understand their experiences with the ComfortTote.Aim 1: Evaluate whether the Comfort Tote intervention leads to greater reductions inself‐reported pain, stress, and anxiety among patients diagnosed with adolescentidiopathic 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 atdischarge. Additionally, this study will examine clinical outcomes, includingsurgical‐site infections, unanticipated readmissions or clinic visits, and dischargemobility, using AM‐PAC mobility scores.Aim 3: Assess patient caregivers' experiences with and perceptions of the Comfort Tote'susefulness using data collected via a brief structured survey.