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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ during first 10 study days

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,737,490 Total Patients Enrolled

12 Trials studying Anxiety

3,271 Patients Enrolled for Anxiety

Anthony Longhini, MDPrincipal InvestigatorYale University School of Medicine, Department of Anesthesiology

Frequently Asked Questions

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

What prerequisites must be met by potential participants in order to qualify for this experiment?

"The criteria for enrollment in this trial requires that potential participants must have anxiety and be between 4 and 14 years old. Presently, the total number of candidates is 178."

Answered by AI

Are septuagenarians being enrolled in the research project?

"The eligibility requirements to partake in this trial necessitates that participants are between 4 and 14 years old. Clinicialtrials.gov hosts 182 trials for minors, with another 449 clinical studies targeting individuals aged 65 or above."

Answered by AI

Is the opportunity for participation in this clinical trial still available to those seeking it?

"The clinicaltrials.gov portal suggests that this trial is no longer accepting patients. It was initially posted on October 26th, 2023 and has not been modified since then. Fortunately, there are 675 other active studies currently recruiting participants for medical research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety

2023. "Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06111742.