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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-13

Study Completion Date

2021-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pediatric Cancer Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Non-AR Group

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.

Group Type SHAM_COMPARATOR

ARISE without AR

Intervention Type DEVICE

An augmented reality game for mobile devices with AR experiences disabled as an control

AR Group

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

Group Type ACTIVE_COMPARATOR

ARISE with AR

Intervention Type DEVICE

An augmented reality game for mobile devices with AR experiences enabled

Interventions

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ARISE with AR

An augmented reality game for mobile devices with AR experiences enabled

Intervention Type DEVICE

ARISE without AR

An augmented reality game for mobile devices with AR experiences disabled as an control

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No