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Interactive Games for Pediatric Perioperative Anxiety

N/A
Waitlist Available
Led By Anthony Longhini, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
4 to 14 years of age
Undergoing non-emergent surgery at Yale New Haven Children's Hospital requiring general anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at induction of anesthesia
Awards & highlights

Study Summary

This trial studies the effects of interactive games on reducing perioperative anxiety in children before surgery. It will compare their effects to standard care without games.

Who is the study for?
This trial is for children aged 4 to 14 who are scheduled for non-emergency surgery under general anesthesia at Yale New Haven Children's Hospital. It's suitable for those having procedures in areas like ENT, eye surgery, orthopedics, dentistry, and more. Kids must be opting for inhalational induction but can't join if they've taken pre-surgery medication or have mental status changes or major hearing/vision issues.Check my eligibility
What is being tested?
The study is testing the Bedside Entertainment and Relaxation Theater (BERT), which uses interactive games as a distraction technique to reduce anxiety before anesthesia in kids. The effectiveness of BERT will be compared with the usual care that doesn't include such games using an observational scale to measure anxiety levels.See study design
What are the potential side effects?
Since this intervention involves audiovisual games rather than medication, side effects may differ from pharmacological approaches and could include overstimulation or frustration related to game interaction; however, these potential side effects are generally considered less severe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 4 and 14 years old.
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I am scheduled for a planned surgery at Yale New Haven Children's Hospital that requires general anesthesia.
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My surgery is related to ENT, eye, bone, dental, stomach, or general surgery.
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I have chosen to be put to sleep for surgery using inhaled medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during first 10 study days
This trial's timeline: 3 weeks for screening, Varies for treatment, and during first 10 study days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient Anxiety assessed by Modified Yale Perioperative Anxiety Score (mYPAS)
Secondary outcome measures
Caretaker Anxiety assessed by Short State Anxiety Inventory Score
Healthcare Professional Opinions on BERT assessed with Health Professional Survey
Patient induction compliance assessed by Induction Compliance Checklist

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Interactive Gaming GroupExperimental Treatment1 Intervention
Subjects will utilize an interactive gaming platform via the Bedside Entertainment and Relaxation Theater (BERT) directly prior to and during induction of anesthesia.
Group II: Standard of CareActive Control1 Intervention
Subjects will be offered standard of care interventions to improve preoperative anxiety. The interactive gaming system under investigation will not be available to this group.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,863 Previous Clinical Trials
2,742,403 Total Patients Enrolled
12 Trials studying Anxiety
3,271 Patients Enrolled for Anxiety
Anthony Longhini, MDPrincipal InvestigatorYale University School of Medicine, Department of Anesthesiology
~119 spots leftby Jun 2025
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