Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety

Yale University

Status: Invitation-only

Conditions: Anxiety

Treatments: Device: Bedside Entertainment and Relaxation Theater (BERT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06111742

2000033851

000

Details and patient eligibility

About

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.

Enrollment: 178 estimated patients

Sex: All

Ages: 4 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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178 participants in 2 patient groups

Interactive Gaming Group

Experimental group

Description:

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

Treatment:

Device: Bedside Entertainment and Relaxation Theater (BERT)

Standard of Care

No Intervention group

Description:

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.