Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-14

Study Completion Date

2024-02-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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Interactive Gaming Group

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

Group Type EXPERIMENTAL

Bedside Entertainment and Relaxation Theater (BERT)

Intervention Type 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.

Standard of Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bedside Entertainment and Relaxation Theater (BERT)

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.

Intervention Type DEVICE

Other Intervention Names

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BERT

Eligibility Criteria

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Inclusion Criteria

* 4 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

Exclusion Criteria

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

Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes