NCT06111742

Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety

Completed NA Results posted Last updated 8 May 2025

What this trial tests

NA trial testing Bedside Entertainment and Relaxation Theater (BERT) in Anxiety in 178 participants. Completed in 12 February 2024.

Timeline

14 November 2023

Primary endpoint
12 February 2024

12 February 2024

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	178
Start date	14 November 2023
Primary completion	12 February 2024
Estimated completion	12 February 2024
Sites	1 location across United States

Drugs / interventions tested

• Bedside Entertainment and Relaxation Theater (BERT)

Conditions studied

• Anxiety — all drugs for Anxiety →

Sponsor

Yale University

Who can join

Adults 4 to 14, any sex, with Anxiety. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS) Primary · 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.

Induction

Group	Value	95% CI
Interactive Gaming Group	5	± 18.3
Standard of Care	21.4	± 22.1

OR entry

Group	Value	95% CI
Interactive Gaming Group	0.18	± 9.7
Standard of Care	8.9	± 10.7

Mean Change in Caretaker Anxiety Assessed by Short State Anxiety Inventory Score Secondary · 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.

Group	Value	95% CI
Interactive Gaming Group	-0.18	± 3.20
Standard of Care	1.89	± 2.84

Healthcare Professional Opinions on BERT Assessed With Health Professional Survey Secondary · 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.

Rated BERT system "very favorable" or "favorable" for continued use

Group	Value	95% CI
Healthcare Professionals	97

Believe system benefited children

Group	Value	95% CI
Healthcare Professionals	97

Believe system benefited caregivers

Group	Value	95% CI
Healthcare Professionals	90

Believe system benefited staff

Group	Value	95% CI
Healthcare Professionals	70

Did not find system disruptive

Group	Value	95% CI
Healthcare Professionals	70

Patient Induction Compliance Assessed by Induction Compliance Checklist Secondary · 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.

Group	Value	95% CI
Interactive Gaming Group	1.0	± 2.2
Standard of Care	2.1	± 2.5

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.