NCT05589857

A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Tolerant Users Undergoing Surgery to Reduce Post-operative Opioid Use

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 5 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

Tto learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients following surgery.

Detailed description

Primary Objective: To assess the efficacy of SpellBound's AR-enabled scavenger hunt to reduce the rate of additional inpatient opioid use in pediatric cancer patients who are chronic/tolerant opioid users undergoing surgery compared to a control non-AR game in a randomized controlled trial. Secondary Objectives: To assess the impact of AR versus non-AR control technology in pediatric oncology patients, including: * Inpatient opioid use * Average daily inpatient pain score * Number of opioid requests during hospital stay * Inpatient PedsQL (quality of life) questionnaire score * Ambulation/"out of bed" movement * Number days to discharge-ready status * Patient experience assessed by satisfaction scores on questionnaire designed by MD Anderson Cancer Center Child Life team * Outpatient opioid use reported at 30, 60, 90 days. * Outpatient pain scores reported at 30, 60, 90 days * Outpatient PedsQL scores reported at 30, 60, and 90 days * Potential adverse events related to the use of AR (i.e., falls).

Conditions

• Cancer

Interventions

Type	Name	Description
DEVICE	IPAD	Participants will play a game using the iPad's standard camera, which will show you your hospital room and the decal/stickers s as they appear in the real world.
DEVICE	Augmented Reality	Participants will play a game through (device camera and application) that add virtual or digital characters and items that let participants view the real world.

Timeline

• Start date: 2022-10-25
• Primary completion: 2024-05-09
• Completion: 2024-05-09
• First posted: 2022-10-21
• Last updated: 2024-10-23

Locations

1 site across 1 country: United States