AnxietyNCT06111742
Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety
A study testing Bedside Entertainment and Relaxation Theater (BERT) in people with Anxiety, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Bedside Entertainment and Relaxation Theater (BERT)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2023to 12 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Altered mental status;
- Significant audiovisual deficits (per parent report and at discretion of study team);
- Received pharmacologic premedication
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Children's Hospital
New Haven, Connecticut, 06510
About this study
Official title: Audiovisual Interactive Games to Improve Pediatric Patient Cooperation With Induction of Anesthesia and Alleviate Perioperative Anxiety
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.
- Conditions
- Anxiety
- Being tested
- Bedside Entertainment and Relaxation Theater (BERT)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside Entertainment and Relaxation Theater (BERT)Device
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Gaming Group | Experimental | Subjects will utilize an interactive gaming platform via the Bedside Entertainment and Relaxation Theater (BERT) directly prior to and during induction of anesthesia. Receives: Device: Bedside Entertainment and Relaxation Theater (BERT) |
| Standard of Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 child participants only. Results presented here are mean change from baseline in anxiety during induction and upon Operating Room (OR) entry.
Measured: Baseline at OR entry (approximately 1 hour after baseline) and At Induction of Anesthesia (approximately 65 minutes after baseline),
Secondary outcomes (3)
Mean Change in 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 collected for caretakers only.
Measured: Baseline, After Induction of Anesthesia (approximately 1 hour after baseline)
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.
Measured: During first 10 study days
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. This will be collected for child participants only.
Measured: At Induction of Anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start14 Nov 2023
- Primary completion12 Feb 2024
- Study completion12 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Longhini, MD, Principal investigator, Yale University School of Medicine, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111742
- Sponsor's protocol ID
- 2000033851
- Other IDs
- 000
- Status last verified
- May 2025
- First submitted
- 26 Oct 2023
- Last updated
- 8 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual participant data, in addition to study protocols, will be made available; the data will be made available on publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiovisual Interactive Games to Improve Pediatric Patient Cooperation With Induction of Anesthesia and Alleviate Perioperative Anxiety
- ClinicalTrials.gov ID
- NCT06111742
- Acronym / sponsor ID
- 2000033851
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Posted 8 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Gaming Group | Experimental | Device: 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. |
| Standard of Care | No intervention | –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. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Altered mental status;
- Significant audiovisual deficits (per parent report and at discretion of study team);
- Received pharmacologic premedication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedside Entertainment and Relaxation Theater (BERT)Also: BERTBERT 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. | Device | Interactive Gaming Group |
Primary outcome
Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS)
Time frame: 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.
3 secondary outcomes
Mean Change in Caretaker Anxiety Assessed by Short State Anxiety Inventory Score
Time frame: Baseline, After Induction of Anesthesia (approximately 1 hour after baseline)
Healthcare Professional Opinions on BERT Assessed With Health Professional Survey
Time frame: During first 10 study days
Patient Induction Compliance Assessed by Induction Compliance Checklist
Time frame: At Induction of Anesthesia
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data, in addition to study protocols, will be made available; the data will be made available on publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Longhini, MD principal investigator
Yale University School of Medicine, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bedside Entertainment and Relaxation Theater (BERT) in people with Anxiety, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS) (time frame: Baseline at OR entry (approximately 1 hour after baseline) and At Induction of Anesthesia (approximately 65 minutes after baseline),). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.