Trial Outcomes & Findings for Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety (NCT NCT06111742)

Last Updated: 2025-05-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

178 participants

Primary outcome timeframe

Baseline at OR entry (approximately 1 hour after baseline) and At Induction of Anesthesia (approximately 65 minutes after baseline),

Results posted on

2025-05-08

Participant Flow

One participant randomized to experimental arm did not receive intervention

Participant milestones

Participant milestones
Measure	Interactive Gaming Group Subjects will utilize an interactive gaming platform via the Bedside Entertainment and Relaxation Theater (BERT) directly prior to and during induction of anesthesia. 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.	Standard of Care 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.	Healthcare Professionals Health care providers' will be asked their opinions on the usefulness of AVG in reducing anxiety and the feasibility of such a program in a health care setting.
Overall Study STARTED	74	74	30
Overall Study Child Participants	37	37	0
Overall Study Caretakers	37	37	0
Overall Study COMPLETED	71	74	30
Overall Study NOT COMPLETED	3	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Interactive Gaming Group Subjects will utilize an interactive gaming platform via the Bedside Entertainment and Relaxation Theater (BERT) directly prior to and during induction of anesthesia. 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.	Standard of Care 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.	Healthcare Professionals Health care providers' will be asked their opinions on the usefulness of AVG in reducing anxiety and the feasibility of such a program in a health care setting.
Overall Study Did not receive intervention	1	0	0
Overall Study Withdrawal by Subject	2	0	0

Baseline Characteristics

Not collected for healthcare professionals.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline at OR entry (approximately 1 hour after baseline) and At Induction of Anesthesia (approximately 65 minutes after baseline),

Outcome measures

Outcome measures
Measure	Interactive Gaming Group n=37 Participants Subjects will utilize an interactive gaming platform via the Bedside Entertainment and Relaxation Theater (BERT) directly prior to and during induction of anesthesia. 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.	Standard of Care n=37 Participants 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.
Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS) Induction	5 score on a scale Standard Deviation 18.3	21.4 score on a scale Standard Deviation 22.1
Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS) OR entry	0.18 score on a scale Standard Deviation 9.7	8.9 score on a scale Standard Deviation 10.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Interactive Gaming Group n=37 Participants Subjects will utilize an interactive gaming platform via the Bedside Entertainment and Relaxation Theater (BERT) directly prior to and during induction of anesthesia. 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.	Standard of Care n=37 Participants 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.
Mean Change in Caretaker Anxiety Assessed by Short State Anxiety Inventory Score	-0.18 score on a scale Standard Deviation 3.20	1.89 score on a scale Standard Deviation 2.84

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Interactive Gaming Group n=30 Participants Subjects will utilize an interactive gaming platform via the Bedside Entertainment and Relaxation Theater (BERT) directly prior to and during induction of anesthesia. 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.	Standard of Care 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.
Healthcare Professional Opinions on BERT Assessed With Health Professional Survey Rated BERT system "very favorable" or "favorable" for continued use	97 percentage of participants	—
Healthcare Professional Opinions on BERT Assessed With Health Professional Survey Believe system benefited children	97 percentage of participants	—
Healthcare Professional Opinions on BERT Assessed With Health Professional Survey Believe system benefited caregivers	90 percentage of participants	—
Healthcare Professional Opinions on BERT Assessed With Health Professional Survey Believe system benefited staff	70 percentage of participants	—
Healthcare Professional Opinions on BERT Assessed With Health Professional Survey Did not find system disruptive	70 percentage of participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Interactive Gaming Group n=37 Participants Subjects will utilize an interactive gaming platform via the Bedside Entertainment and Relaxation Theater (BERT) directly prior to and during induction of anesthesia. 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.	Standard of Care n=37 Participants 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.
Patient Induction Compliance Assessed by Induction Compliance Checklist	1.0 score on a scale Standard Deviation 2.2	2.1 score on a scale Standard Deviation 2.5

Adverse Events

Interactive Gaming Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthcare Professionals

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Harrison Pravder

Boston Children's Hospital, Harvard Medical School

Phone: 516-426-8166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Interactive Gaming Group n=74 Participants Subjects will utilize an interactive gaming platform via the Bedside Entertainment and Relaxation Theater (BERT) directly prior to and during induction of anesthesia. 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.	Standard of Care n=74 Participants 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.	Healthcare Professionals n=30 Participants Health care providers' will be asked their opinions on the usefulness of AVG in reducing anxiety and the feasibility of such a program in a health care setting.	Total n=178 Participants Total of all reporting groups
Age, Continuous Child participants	7.35 years STANDARD_DEVIATION 2.04 • n=37 Participants • Not collected for healthcare professionals.	6.43 years STANDARD_DEVIATION 1.98 • n=37 Participants • Not collected for healthcare professionals.	—	6.89 years STANDARD_DEVIATION 2.05 • n=74 Participants • Not collected for healthcare professionals.
Age, Continuous Caregivers	37.8 years STANDARD_DEVIATION 6.1 • n=37 Participants • Not collected for healthcare professionals.	37 years STANDARD_DEVIATION 7 • n=37 Participants • Not collected for healthcare professionals.	—	37.4 years STANDARD_DEVIATION 6.07 • n=74 Participants • Not collected for healthcare professionals.
Sex: Female, Male Child Participants · Female	18 Participants n=37 Participants • Not collected for healthcare professionals.	17 Participants n=37 Participants • Not collected for healthcare professionals.	—	35 Participants n=74 Participants • Not collected for healthcare professionals.
Sex: Female, Male Child Participants · Male	19 Participants n=37 Participants • Not collected for healthcare professionals.	20 Participants n=37 Participants • Not collected for healthcare professionals.	—	39 Participants n=74 Participants • Not collected for healthcare professionals.
Sex: Female, Male Caregivers · Female	29 Participants n=37 Participants • Not collected for healthcare professionals.	32 Participants n=37 Participants • Not collected for healthcare professionals.	—	61 Participants n=74 Participants • Not collected for healthcare professionals.
Sex: Female, Male Caregivers · Male	8 Participants n=37 Participants • Not collected for healthcare professionals.	5 Participants n=37 Participants • Not collected for healthcare professionals.	—	13 Participants n=74 Participants • Not collected for healthcare professionals.
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=37 Participants • Not collected for Caregivers or Healthcare Providers	13 Participants n=37 Participants • Not collected for Caregivers or Healthcare Providers	—	26 Participants n=74 Participants • Not collected for Caregivers or Healthcare Providers
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=37 Participants • Not collected for Caregivers or Healthcare Providers	24 Participants n=37 Participants • Not collected for Caregivers or Healthcare Providers	—	45 Participants n=74 Participants • Not collected for Caregivers or Healthcare Providers
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=37 Participants • Not collected for Caregivers or Healthcare Providers	0 Participants n=37 Participants • Not collected for Caregivers or Healthcare Providers	—	3 Participants n=74 Participants • Not collected for Caregivers or Healthcare Providers
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants • Not collected for healthcare professionals or caregivers.	0 Participants n=37 Participants • Not collected for healthcare professionals or caregivers.	—	0 Participants n=74 Participants • Not collected for healthcare professionals or caregivers.
Race (NIH/OMB) Asian	1 Participants n=37 Participants • Not collected for healthcare professionals or caregivers.	4 Participants n=37 Participants • Not collected for healthcare professionals or caregivers.	—	5 Participants n=74 Participants • Not collected for healthcare professionals or caregivers.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants • Not collected for healthcare professionals or caregivers.	0 Participants n=37 Participants • Not collected for healthcare professionals or caregivers.	—	0 Participants n=74 Participants • Not collected for healthcare professionals or caregivers.
Race (NIH/OMB) Black or African American	7 Participants n=37 Participants • Not collected for healthcare professionals or caregivers.	5 Participants n=37 Participants • Not collected for healthcare professionals or caregivers.	—	12 Participants n=74 Participants • Not collected for healthcare professionals or caregivers.
Race (NIH/OMB) White	26 Participants n=37 Participants • Not collected for healthcare professionals or caregivers.	25 Participants n=37 Participants • Not collected for healthcare professionals or caregivers.	—	51 Participants n=74 Participants • Not collected for healthcare professionals or caregivers.
Race (NIH/OMB) More than one race	2 Participants n=37 Participants • Not collected for healthcare professionals or caregivers.	2 Participants n=37 Participants • Not collected for healthcare professionals or caregivers.	—	4 Participants n=74 Participants • Not collected for healthcare professionals or caregivers.
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=37 Participants • Not collected for healthcare professionals or caregivers.	1 Participants n=37 Participants • Not collected for healthcare professionals or caregivers.	—	2 Participants n=74 Participants • Not collected for healthcare professionals or caregivers.
Region of Enrollment United States	37 participants n=37 Participants • Not collected for healthcare professionals or caregivers.	37 participants n=37 Participants • Not collected for healthcare professionals or caregivers.	—	74 participants n=74 Participants • Not collected for healthcare professionals or caregivers.
Healthcare Professional Title Anesthesiologist	0 Participants Only collected for healthcare professionals	0 Participants Only collected for healthcare professionals	5 Participants n=30 Participants • Only collected for healthcare professionals	5 Participants n=30 Participants • Only collected for healthcare professionals
Healthcare Professional Title Anesthesiology Resident/Fellow	0 Participants Only collected for healthcare professionals	0 Participants Only collected for healthcare professionals	8 Participants n=30 Participants • Only collected for healthcare professionals	8 Participants n=30 Participants • Only collected for healthcare professionals
Healthcare Professional Title Circulating Nurse	0 Participants Only collected for healthcare professionals	0 Participants Only collected for healthcare professionals	6 Participants n=30 Participants • Only collected for healthcare professionals	6 Participants n=30 Participants • Only collected for healthcare professionals
Healthcare Professional Title Certified Registered Nurse Anesthetist (CRNA)	0 Participants Only collected for healthcare professionals	0 Participants Only collected for healthcare professionals	3 Participants n=30 Participants • Only collected for healthcare professionals	3 Participants n=30 Participants • Only collected for healthcare professionals
Healthcare Professional Title Scrub Technologist	0 Participants Only collected for healthcare professionals	0 Participants Only collected for healthcare professionals	3 Participants n=30 Participants • Only collected for healthcare professionals	3 Participants n=30 Participants • Only collected for healthcare professionals
Healthcare Professional Title Surgery Resident/Fellow	0 Participants Only collected for healthcare professionals	0 Participants Only collected for healthcare professionals	5 Participants n=30 Participants • Only collected for healthcare professionals	5 Participants n=30 Participants • Only collected for healthcare professionals
Caregiver Relationship to Participant Parent	34 Participants n=37 Participants • Only collected for caregivers.	37 Participants n=37 Participants • Only collected for caregivers.	—	71 Participants n=74 Participants • Only collected for caregivers.
Caregiver Relationship to Participant Other	3 Participants n=37 Participants • Only collected for caregivers.	0 Participants n=37 Participants • Only collected for caregivers.	—	3 Participants n=74 Participants • Only collected for caregivers.
Caregiver Surgical History, Previous Surgery Yes	23 Participants n=37 Participants • Only collected for caregivers.	28 Participants n=37 Participants • Only collected for caregivers.	—	51 Participants n=74 Participants • Only collected for caregivers.
Caregiver Surgical History, Previous Surgery No	14 Participants n=37 Participants • Only collected for caregivers.	9 Participants n=37 Participants • Only collected for caregivers.	—	23 Participants n=74 Participants • Only collected for caregivers.
Short State Anxiety Inventory Score at baseline	10.5 score on a scale STANDARD_DEVIATION 5.3 • n=37 Participants • Only collected for caregivers.	11.4 score on a scale STANDARD_DEVIATION 3.1 • n=37 Participants • Only collected for caregivers.	—	10.95 score on a scale STANDARD_DEVIATION 3.3 • n=74 Participants • Only collected for caregivers.