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| ID | Type | Description | Link |
|---|---|---|---|
| 000 | Other Identifier | CTGTY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bedside Entertainment and Relaxation Theater (BERT) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline at OR entry (approximately 1 hour after baseline) and At Induction of Anesthesia (approximately 65 minutes after baseline), |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Longhini, MD | Yale University School of Medicine, Department of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Children's Hospital | New Haven | Connecticut | 06510 | United States |
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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One participant randomized to experimental arm did not receive intervention
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Not collected for healthcare professionals. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 child participants only. Results presented here are mean change from baseline in anxiety during induction and upon Operating Room (OR) entry. | Posted | Mean | Standard Deviation | score on a scale | Baseline at OR entry (approximately 1 hour after baseline) and At Induction of Anesthesia (approximately 65 minutes after baseline), |
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up to one month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harrison Pravder | Boston Children's Hospital, Harvard Medical School | 516-426-8166 | hpravder@meei.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 28, 2023 | Jan 31, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 28, 2023 | Jan 31, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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In the first phase (baseline measurement) neither participant nor investigator will be aware of the subjects group assignment. After this phase, due to the nature of the intervention, the experimental group will be aware they are in the intervention group when they see the gaming system.
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| 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. | 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. | At Induction of Anesthesia |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Not collected for healthcare professionals. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Not collected for Caregivers or Healthcare Providers | Count of Participants | Participants |
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| Race (NIH/OMB) | Not collected for healthcare professionals or caregivers. | Count of Participants | Participants |
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| Region of Enrollment | Not collected for healthcare professionals or caregivers. | Number | participants |
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| Healthcare Professional Title | Only collected for healthcare professionals | Count of Participants | Participants |
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| Caregiver Relationship to Participant | Only collected for caregivers. | Count of Participants | Participants |
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| Caregiver Surgical History, Previous Surgery | Only collected for caregivers. | Count of Participants | Participants |
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| Short State Anxiety Inventory Score at baseline | Score ranges from 6 to 24, higher scores suggest higher levels of anxiety. | Only collected for caregivers. | Mean | Standard Deviation | score on a scale |
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| OG001 | 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. |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, After Induction of Anesthesia (approximately 1 hour after baseline) |
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| 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. | Posted | Number | percentage of participants | During first 10 study days |
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| 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. This will be collected for child participants only. | Posted | Mean | Standard Deviation | score on a scale | At Induction of Anesthesia |
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| 0 |
| 74 |
| 0 |
| 74 |
| 0 |
| 74 |
| EG001 | 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. | 0 | 74 | 0 | 74 | 0 | 74 |
| EG002 | 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. | 0 | 30 | 0 | 30 | 0 | 30 |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
| Female |
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| Male |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Believe system benefited staff |
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| Did not find system disruptive |
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