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Augmented Reality Game for Pediatric Cancer
Phase 2
Waitlist Available
Led By Juan Cata, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of study, an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if a game can help young patients reduce pain and the need for opioids before surgery.
Who is the study for?
This trial is for children aged 5-15 with cancer, scheduled for major surgery requiring at least one night's hospital stay. They must be opioid-naïve, able to understand and interact with an iPad game, and have parents/guardians who can consent. Children over 15 or those with prior neuropathy or recent opioid use are excluded.
What is being tested?
The study tests if a SpellBound augmented reality game on an iPad can help reduce pain and lessen the need for opioids in pediatric patients after surgery. It's a randomized controlled trial comparing game interaction outcomes against standard postoperative care.
What are the potential side effects?
Since this intervention involves playing an augmented reality game rather than medication, typical drug side effects aren't expected. However, there may be non-medical concerns such as eye strain or frustration if difficulty using the app occurs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of study, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of study, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pediatric Quality of Life Inventory Questionnaires
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2 (Spellbound)Experimental Treatment1 Intervention
Participants will play the game using augmented reality
Group II: Group 1(Spellbound)Experimental Treatment1 Intervention
Participants will play the game using the iPad's standard camera, which will show you your hospital room and the decals as they appear in the real world.
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,826 Previous Clinical Trials
8,169,597 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,798 Total Patients Enrolled
Juan Cata, MDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
171 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am expected to need strong painkillers after surgery.I am scheduled for a major cancer surgery that requires staying in the hospital overnight.I am between the ages of 5 and 15.I have not used opioids daily in the last 30 days.I (or my legal guardian) can communicate in English or Spanish.I can use an iPad and interact with apps as needed for the study.I have nerve damage from cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1(Spellbound)
- Group 2: Group 2 (Spellbound)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.