A Pilot Randomized Controlled Trial for Feasibility of Administering an AR Game to Postoperative Pediatric Cancer Patients
- Conditions
- Pediatric CancerSurgery
- Interventions
- Device: ARISE with ARDevice: ARISE without AR
- Registration Number
- NCT04674150
- Lead Sponsor
- ALTality, Inc.
- Brief Summary
This is a pilot study to evaluate the feasibility of SpellBound's AR (augmented reality)-enabled scavenger hunt use among 20 pediatric cancer patients undergoing surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Ages 3-18
- English speaking parents/legal guardians and patients
- Undergoing major surgery for cancer requiring postoperative hospitalization defined as ≥2 hours of duration of surgery and requiring postoperative hospital admission of at least one night
- Expected to be prescribed postoperative inpatient opioids
- Have never taken opioids or have had no daily opioid use within the last 30 days
- Sufficient cognitive capacity to comprehend and interact with the game. This is defined as ability to utilize mobile technology (use iPad with or without assistance) and activate and respond to AR experiences within the app as determined by the clinician.
- Both child and a legal guardian are willing and able to provide informed consent.
- History of documented peripheral neuropathy secondary to cancer treatment
- Inability to demonstrate an understanding of the game from English instructions
- Have previous played the ARISETM digital scavenger hunt game
- Any additional concerns based on the study physicians' assessments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AR Group ARISE with AR Patients randomized to the AR group will be able to use the iPad and SpellBound app to initiate the AR experiences in the game. Non-AR Group ARISE without AR Patients allocated to the control group will be able to interact with the iPad and visualize objects and decals in the walls but not able to initiate the AR technology. In other terms, patients in this group will be provided with the same iPad to the AR group patients with the only exception that the AR technology will be off and will only see objects through the device camera in normal reality.
- Primary Outcome Measures
Name Time Method Percentage of patients who receive the AR game who are able to initiate the game and activate any targets with 1% error rate The patient's postoperative inpatient hospital stay, average 7 days Success defined as at least 80% of patients who receive the AR game being able to initiate the game and activate any targets with 1% error rate
- Secondary Outcome Measures
Name Time Method Inpatient opioid use The patient's postoperative inpatient hospital stay, average 7 days The average daily inpatient MEDD (morphine equivalent dose) will be calculated from the electronic medical record as previously used in pediatric cancer surgical patients by the investigator
Outpatient opioid use The patient's postoperative inpatient hospital stay, average 7 days We will record whether the patient has any active opioid prescription 90-days (±10 Days) after surgery. This data will be confirmed by direct contact to patients' caregivers or via pharmacy registries on filled prescriptions.
Average daily inpatient pain score The patient's postoperative inpatient hospital stay, average 7 days Age-appropriate pain-intensity scores will be determined using Visual and Colored Analogue Scales (VAS). This is a 10-point colored scaled validated for measuring pain intensity in pediatric populations and will be assessed twice daily at 9AM and 5PM.
Number of opioid requests (rescue analgesia) The patient's postoperative inpatient hospital stay, average 7 days We will record the total number of times opioids were required by patients to nurses and the patient-controlled analgesia infusion pumps during the inpatient period as recorded in the electronic medical record.
Quality of life assessment The patient's postoperative inpatient hospital stay, average 7 days Age-appropriate Pediatric Quality of Life Inventory (PedsQL) paper surveys will be administered to the patient (self-report) or guardian (proxy) when patients reach discharge-ready status.
Ambulation/ "out of bed" movement The patient's postoperative inpatient hospital stay, average 7 days Distance (meters) achieved "out of bed" (ambulatory or non-ambulatory/wheelchair) during their inpatient stay while interacting with the app will be calculated by hand, based on how many times patient activated specific targets.
Discharge-ready status The patient's postoperative inpatient hospital stay, average 7 days The number of days to discharge-ready status will be determined by the study physicians. This status will be assessed twice daily at 9AM and 5PM.
Patient experience The patient's postoperative inpatient hospital stay, average 7 days In the patients who receive the AR game, responses to an electronic survey on the patient's experience designed by the MDACC Child Life team will be recorded when patients reach discharge-ready status.
Outpatient pain scores 90 days after the patient is discharged from the hospital We will record average pain intensity experience by the patient during the 90-day (±10 Days) post surgery period. This data will be confirmed by direct contact to patient's guardian or as recorded in the electronic medical record during the patient's follow-up clinic visit
Outpatient quality of life 90 days after the patient is discharged from the hospital Age-appropriate Pediatric Quality of Life Inventory (PedsQL) surveys will be administered to the patient (self-report) or guardian (proxy) by phone.
Trial Locations
- Locations (2)
Texas Children's Hospital
🇺🇸Houston, Texas, United States
M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States