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Augmented Reality Game for Pediatric Cancer Post-Surgery Pain Management

Phase 2

Recruiting

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

Study Summary

This trial tests if a video game can reduce pain, lower opioid use in young surgical patients.

Who is the study for?

This trial is for kids aged 5-15 with cancer, who are undergoing major surgery and will stay in the hospital afterwards. They must have been taking opioids daily for at least a month before surgery, be able to play an iPad game, and understand English or Spanish instructions. Kids over 15 or those new to opioids aren't eligible.Check my eligibility

What is being tested?

The study tests if a game on the iPad using augmented reality (AR), called SpellBound, can help reduce pain and lessen the need for opioid painkillers after surgery in children who regularly use these medications.See study design

What are the potential side effects?

Since this trial involves playing an AR game rather than a drug or medical procedure, there may not be traditional side effects. However, potential discomforts could include eye strain or frustration from interacting with technology.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of study, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pediatric Quality of Life Inventory

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 SpellBound 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IPAD

2016

N/A

~100

Augmented Reality

2020

N/A

~200

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,283 Total Patients Enrolled

Juan Cata, MDPrincipal InvestigatorMD Anderson

5 Previous Clinical Trials

205 Total Patients Enrolled

Media Library

Group 1 (Spellbound) Clinical Trial Eligibility Overview. Trial Name: NCT05589857 — Phase 2

Cancer Research Study Groups: Group 1 (Spellbound), Group 2 (Spellbound)

Cancer Clinical Trial 2023: Group 1 (Spellbound) Highlights & Side Effects. Trial Name: NCT05589857 — Phase 2

Group 1 (Spellbound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05589857 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for participants in this experiment?

"Based on what is posted to clinicaltrials.gov, this particular trial has ceased recruiting as of October 20th 2022. Initially listed on December 1st 20202, it is no longer looking for new participants; however, there are 484 other trials still actively searching for suitable candidates at this time."

Answered by AI

Do any participants aged 70 and below qualify for this experiment?

"The prerequisites for entering this clinical trial is that the participant must be between 5 and 15 years old. There are 61 trials focusing on younger patients, while 431 focus on elderly persons."

Answered by AI

To what extent could individuals be at risk by engaging with Group 1 (Spellbound)?

"Our Power team ascribed Group 1 (Spellbound) with a safety rating of 2 due to the presence of supporting data for its security, yet an absence of any backing up its efficacy."

Answered by AI

Who is eligible to participate in this clinical research?

"This medical trial is searching for 34 patients with malignancies between the ages of 5 and 15. The list of requirements to be eligible include: fluency in English or Spanish, undergoing a significant surgery related to cancer that requires postoperative hospitalization longer than two hours and at least one night, prescribed daily opioids prior to the operation over 30 days long, possessing cognitive capabilities sufficient enough utilize mobile technology (iPad with/without assistance) as well as interact with AR within an app determined by the clinician., consent from both patient and legal guardian are necessary, age range limited due to lack of interest from older adolescents (>15)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05589857.

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