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Spots Global Cancer Trial Database for A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Naïve Undergoing Surgery to Reduce Postoperative Opioid Use (GAMING-ON Study)

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Trial Identification

Brief Title: A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Naïve Undergoing Surgery to Reduce Postoperative Opioid Use (GAMING-ON Study)

Official Title: A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Naïve Undergoing Surgery to Reduce Postoperative Opioid Use (GAMING-ON Study)

Study ID: NCT05466994

Study Description

Brief Summary: To learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients scheduled for surgery.

Detailed Description: Primary Objective: •To assess the efficacy of SpellBound's AR-enabled scavenger hunt to reduce the rate of 90-day opioid use in pediatric cancer patients undergoing surgery compared to a control non-AR game in a randomized controlled trial. Secondary Objectives: To assess the effect 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 the 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 a questionnaire designed by MD Anderson Cancer Center Child Life team. * Outpatient opioid consumption reported at 30, 60, and 90 days * Outpatient pain scores reported at 30, 60, and 90 days * Outpatient PedsQL scores reported at 30, 60, and 90 days * Potential adverse events related to the use of AR (i.e., falls).

Keywords

Eligibility

Minimum Age: 5 Years

Eligible Ages: CHILD

Sex: ALL

Healthy Volunteers: No

Locations

M D Anderson Cancer Center, Houston, Texas, United States

Texas Children's Hospital, Houston, Texas, United States

Contact Details

Name: Juan Cata, MD

Affiliation: M.D. Anderson Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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