Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety

Anxiety Clinical Trial

Official title:

Audiovisual Interactive Games to Improve Pediatric Patient Cooperation With Induction of Anesthesia and Alleviate Perioperative Anxiety

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06111742
• Other study ID #: 2000033851
• Secondary ID: 000
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 14, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 178
• Est. completion date: April 30, 2024
• Est. primary completion date: February 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Yale New Haven Children's Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Anxiety assessed by Modified Yale Perioperative Anxiety Score (mYPAS)	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 patients only.	Baseline, At Induction of Anesthesia (approximately 1 hour after baseline)
Secondary	Caretaker Anxiety assessed by Short State Anxiety Inventory Score	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 used for caretakers only.	Baseline, After Induction of Anesthesia (approximately 1 hour after baseline)
Secondary	Healthcare Professional Opinions on BERT assessed with Health Professional Survey	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.	During first 10 study days
Secondary	Patient induction compliance assessed by Induction Compliance Checklist	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	At Induction of Anesthesia