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Virtual Reality Game for Anxiety

N/A
Waitlist Available
Led By Amy Drendel, DO, MS
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children ages 6 years to 17.5 years old receiving procedural sedation with IV ketamine in the Children's Hospital of Wisconsin Emergency Department for long bone fracture reduction
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This study is evaluating whether a virtual reality game can help reduce negative behavior changes following a fracture reduction.

Eligible Conditions
  • Childhood Behavior
  • Anxiety

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-Hospitalization Behavior Questionnaire (PHBQ)
Secondary outcome measures
Modified Yale Preoperative Anxiety Scale (m-YPAS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Reality GroupExperimental Treatment1 Intervention
The children in the experimental group will receive the standard of care (access to in room activity including television (TV) distraction if desired, parent support and distraction at bedside, and quiet time) in addition to our intervention, an interactive virtual reality game, played for a minimum of 5 minutes prior to procedural sedation.
Group II: Standard of CareActive Control1 Intervention
The children in the control group receiving standard of care will have access to in room activity including TV distraction if desired, parent support and distraction at bedside, and quiet time.

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,382 Total Patients Enrolled
3 Trials studying Anxiety
60 Patients Enrolled for Anxiety
Amy Drendel, DO, MSPrincipal Investigator - Medical College of Wisconsin
Children's Hospital of Wisconsin
Chicago College Of Osteopathic Medicine (Medical School)
Rush-Presby-St Luke'S M C (Residency)
1 Previous Clinical Trials
205 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Anesthesia & AnalgesiaJournal
Distress During the Induction of Anesthesia and Postoperative Behavioral Outcomes
Kain, Zeev N., Shu Ming Wang, Linda C. Mayes, Lisa A. Caramico, and Maura B. Hofstadter. 1999. “Distress During the Induction of Anesthesia and Postoperative Behavioral Outcomes”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00000539-199905000-00013.
PediatricsJournal
Evaluation of Nonpharmacologic Methods of Pain and Anxiety Management for Laceration Repair in the Pediatric Emergency Department
Sinha, Madhumita, Norman C. Christopher, Robin Fenn, and Laurie Reeves. 2006. “Evaluation of Nonpharmacologic Methods of Pain and Anxiety Management for Laceration Repair in the Pediatric Emergency Department”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2005-1100.
Archives of Pediatrics & Adolescent MedicineJournal
Preoperative Anxiety in Children
Kain, Zeev N.. 1996. “Preoperative Anxiety in Children”. Archives of Pediatrics & Adolescent Medicine. American Medical Association (AMA). doi:10.1001/archpedi.1996.02170370016002.
clinicaltrials.govStudy
Impact of Pre-Sedation Virtual Reality Game on Post-Discharge Negative Behaviors in the Pediatric Emergency Department
Amy Drendel 2019. "Impact of Pre-Sedation Virtual Reality Game on Post-Discharge Negative Behaviors in the Pediatric Emergency Department". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03980067.
~34 spots leftby Apr 2025
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