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.
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.
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)
Parallel
The Therapeutic Comfort Tote
Other interventionThe 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 Tote
Other interventionThe 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.
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.
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.
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.
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).
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.
Length of stay
Secondary outcomes include length of hospital stay (LOS) in days.
ICU LOS
Secondary outcomes include Intensive Care Unit (ICU) LOS in days.
Total direct cost
Secondary outcomes include total direct costs (TDC) in dollars.
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