Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety

Not Applicable

Completed

Conditions: Anxiety

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

Registration Number: NCT06111742

Lead Sponsor: Yale University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 178

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS)	Baseline at OR entry (approximately 1 hour after baseline) and At Induction of Anesthesia (approximately 65 minutes after baseline),	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.

Secondary Outcome Measures

Name	Time	Method
Healthcare Professional Opinions on BERT Assessed With Health Professional Survey	During first 10 study days	This survey will obtain health care providers' opinions on the usefulness of using the BERT system in reducing anxiety and the feasibility of such a program in a health care setting. Eligible individuals include: physicians, physician assistants/advanced practice providers, nurses, and other operating room staff.
Mean Change in Caretaker Anxiety Assessed by Short State Anxiety Inventory Score	Baseline, After Induction of Anesthesia (approximately 1 hour after baseline)	The Short State Anxiety Inventory is a 6-item validated measure of anxiety in subjects aged 5 years and older. Subjects are asked to rate how they felt on a 4-point Likert scale in relation to feeling calm, tense, upset, relaxed, content, or worried. A score of 1 correlates to "not at all" and a score of 4 correlates to "very much." The final score is the sum of recorded values and ranges from 6 to 24, higher scores suggest higher levels of anxiety. This will be collected for caretakers only.
Patient Induction Compliance Assessed by Induction Compliance Checklist	At Induction of Anesthesia	The Induction Compliance Checklist is a validated 10-item observer-rated checklist of behaviors that interfere with induction of anesthesia. The score is the sum of the items checked. A perfect induction (the child does not exhibit negative behaviors, fear, or anxiety) is scored as 0, whereas the worst induction is a score of 9. A score greater than six is considered "poor" compliance. This will be collected for child participants only.