A Pilot Randomized Controlled Trial for Feasibility of Administering an AR Game to Postoperative Pediatric Cancer Patients (GAMING)

ALTality

Status and phase: Unknown; Phase 1

Conditions: Surgery; Pediatric Cancer

Treatments: Device: ARISE with AR; Device: ARISE without AR

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04674150

ARISE GAMING (Phase I)

1R42DA050365-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ages 3-18
2. English speaking parents/legal guardians and patients
3. 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
4. Expected to be prescribed postoperative inpatient opioids
5. Have never taken opioids or have had no daily opioid use within the last 30 days
6. 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.
7. Both child and a legal guardian are willing and able to provide informed consent.

Exclusion criteria

1. History of documented peripheral neuropathy secondary to cancer treatment
2. Inability to demonstrate an understanding of the game from English instructions
3. Have previous played the ARISETM digital scavenger hunt game
4. Any additional concerns based on the study physicians' assessments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Non-AR Group

Sham Comparator group

Description:

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.

Treatment:

Device: ARISE without AR

AR Group

Active Comparator group

Description:

Patients randomized to the AR group will be able to use the iPad and SpellBound app to initiate the AR experiences in the game.

Treatment:

Device: ARISE with AR