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)

Last updated: October 10, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Not Recruiting

Phase

2

Condition

Cancer

Neoplasms

Treatment

IPAD

Augmented Reality

Clinical Study ID

NCT05466994
2022-0336
NCI-2022-05979
  • Ages 5-15
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ages 5-15

  2. English and Spanish-speaking parents/legal guardians and patients

  3. Undergoing major surgery for cancer requiring postoperative hospitalization isdefined as ≥2 hours of duration of surgery and requiring postoperative hospitaladmission 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 daysbefore surgery

  6. Sufficient cognitive capacity to comprehend and interact with the game. This isdefined as the ability to utilize mobile technology (use iPad with or withoutassistance) and activate and respond to AR experiences within the app as determinedby the clinician.

  7. Both the child and a legal guardian are willing and able to provide informedconsent.

  • The range from 5-to 15 is based on a recent pilot RCT in which the PI foundthat older adolescents (>15 years of age) were disinterested in the interactivegame.

Exclusion

Exclusion Criteria:

  1. Patients with any daily opioid use within 30 days before surgery.

  2. History of documented peripheral neuropathy secondary to cancer treatment

  3. Inability to demonstrate an understanding of the game from English instructions

  4. Any additional concerns based on the study physicians' assessments

Study Design

Total Participants: 29
Treatment Group(s): 2
Primary Treatment: IPAD
Phase: 2
Study Start date:
August 19, 2022
Estimated Completion Date:
October 31, 2026

Study 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).

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • M D Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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