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)

RECRUITING

I'm interested ...!!

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

Conditions:

Pediatric ALL Cancer

Study Start (Actual) 2022-08-19

Primary Completion (Estimated) 2026-10-31

Study Completion (Estimated) 2026-10-31

Enrollment (Estimated) 34

Study Type INTERVENTIONAL

Phase PHASE2

Locations:

📍 Houston, Texas, United States

Eligibility Criteria

Description

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 is 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 before surgery
6. Sufficient cognitive capacity to comprehend and interact with the game. This is defined as the 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 the child and a legal guardian are willing and able to provide informed consent.
* The range from 5-to 15 is based on a recent pilot RCT in which the PI found that older adolescents (\>15 years of age) were disinterested in the interactive game.

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

Ages Eligible for Study: 5 Years to 15 Years (CHILD)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2022-07-18
First Submitted that Met QC Criteria2022-07-18
First Posted2022-07-20

Study Record Updates

Last Update Submitted that Met QC Criteria2024-03-06
Last Update Posted2024-03-07
Last Verified2024-03