Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety

NCT06111742 | Completed Results FDA Device

• 2 other identifiers: 2000033851000
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric anxiety upon induction of anesthesia is widely prevalent and can lead to negative patient psychological impact and hindrance to induction of anesthesia. Historically, premedication has been used as one means to improve pediatric preoperative anxiety and cooperation with induction. However, giving medication to children prior to surgery has drawbacks. Thus, other means have been proposed that may have similar benefits but fewer or different drawbacks. Recently, audiovisual distraction in the form of interactive games has been proposed. Such games have been in use at children's hospitals around the United States for more than five years. This study is a randomized trial that will explore using interactive games to improve pediatric perioperative anxiety in elective surgery compared with standard-of-care not including games. Perioperative anxiety with be evaluated using an observational scale.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS)

  The mYPAS is the gold standard for measuring pediatric perioperative anxiety. It is an observational-based 22-item instrument divided into five categories: activity, emotional expressivity, state of arousal, vocalization, and use of parents. The score ranges from 23 to 100, higher scores suggest higher levels of anxiety. It was developed at Yale University. This will be used for child participants only. Results presented here are mean change from baseline in anxiety during induction and upon Operating Room (OR) entry.

  Baseline at OR entry (approximately 1 hour after baseline) and At Induction of Anesthesia (approximately 65 minutes after baseline),

Secondary Outcomes (3)

• Mean Change in Caretaker Anxiety Assessed by Short State Anxiety Inventory Score

  Baseline, After Induction of Anesthesia (approximately 1 hour after baseline)

• Healthcare Professional Opinions on BERT Assessed With Health Professional Survey

  During first 10 study days

• Patient Induction Compliance Assessed by Induction Compliance Checklist

  At Induction of Anesthesia

Study Arms (2)

Interactive Gaming Group

EXPERIMENTAL

Subjects will utilize an interactive gaming platform via the Bedside Entertainment and Relaxation Theater (BERT) directly prior to and during induction of anesthesia.

Device: Bedside Entertainment and Relaxation Theater (BERT)

Standard of Care

NO 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.

Interventions

Bedside Entertainment and Relaxation Theater (BERT) DEVICE

BERT is a Nebula Capsule Max portable projector that creates a familiar theater experience designed for children to divert attention away from procedures. It is fitted with a remote control that can be utilized to manage on-screen activities. BERT can be used with any wall, ceiling, or projector screen to create the theater experience with a large screen. It can also be used with assist devices, such as steering wheel and noise-canceling headphones.

Also known as: BERT

Interactive Gaming Group

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to 14 years of age;
• Undergoing non-emergent surgery at Yale New Haven Children's Hospital requiring general anesthesia;
• Chooses inhalational induction as induction method;
• Surgery qualified under one or more of the following fields: otolaryngology, ophthalmology, orthopedics, dentistry, gastrointestinal, general surgery

You may not qualify if:

• Altered mental status;
• Significant audiovisual deficits (per parent report and at discretion of study team);
• Received pharmacologic premedication

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Children's Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Harrison Pravder
• Organization: Boston Children's Hospital, Harvard Medical School

hpravder@meei.harvard.edu

516-426-8166

Study Officials

• Anthony Longhini, MD

  Yale University School of Medicine, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In the first phase (baseline measurement) neither participant nor investigator will be aware of the subjects group assignment. After this phase, due to the nature of the intervention, the experimental group will be aware they are in the intervention group when they see the gaming system.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: November 14, 2023
• Primary Completion: February 12, 2024
• Study Completion: February 12, 2024
• Last Updated: May 8, 2025
• Results First Posted: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)