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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic Comfort Tote | Active Comparator | Participants will be randomly assigned to receive the Therapeutic Comfort Tote. |
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| Modified Comfort Tote | Placebo Comparator | Participants will be randomly assigned to receive the Modified Comfort Tote. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Therapeutic Comfort Tote | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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). | From surgery date up to four weeks after surgery |
| Primary Outcome: Caregiver's impression |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From surgery date up to four weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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Patients and family will not know if the Comfort Tote they receive upon randomization is therapeutic or modified.
|
| The Modified Comfort Tote | Other | 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. |
|
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. |
| From surgery date up to four weeks after surgery |
| Length of stay | Secondary outcomes include length of hospital stay (LOS) in days. | 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. | 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. | 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. | 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. | From discharge from hospital until up to four weeks after surgery |
| Surgical site infections | Secondary outcomes include surgical site infections. | From surgery date until up to four weeks after surgery |
| Readmissions | Secondary outcomes include readmissions, defined as hospital admissions within 30 days of discharge. | Assessed up to 4 weeks after surgery |
| Unanticipated return to clinic | Secondary outcomes include unanticipated return to clinic. | 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 | Assessed up to 4 weeks after surgery |
| Gabapentin use | Secondary outcomes include whether or not patients took Gabapentin. | 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. | From discharge until up to four weeks after surgery |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D001523 | Mental Disorders |
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