N/A
N=178
Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety
Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT06111742 ↗Enrolled (actual)
178
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS) — 5; 21.4; 0.18; 8.9 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bedside Entertainment and Relaxation Theater (BERT) (Device)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS) |
5; 21.4; 0.18; 8.9 | <0.001 sig |
| SECONDARY Mean Change in Caretaker Anxiety Assessed by Short State Anxiety Inventory Score |
-0.18; 1.89 | 0.022 sig |
| SECONDARY Healthcare Professional Opinions on BERT Assessed With Health Professional Survey |
97; 97; 90; 70; 70 | — |
| SECONDARY Patient Induction Compliance Assessed by Induction Compliance Checklist |
1.0; 2.1 | 0.046 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06111742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.