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The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial.
The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial. We will be enrolling patients age 5-12 years presenting for elective surgery.
Patients will be randomized to one of two groups: (1) virtual reality headset with routine anesthetic care and (2) routine anesthetic care only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perioperative virtual reality headset | Experimental | Perioperative virtual reality headset with mobile app and routine anesthetic care |
|
| Control | No Intervention | Routine anesthetic care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perioperative virtual reality headset with mobile app | Device | Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Pediatric Anxiety (Change From Baseline) | Modified Yale Preoperative Anxiety Scale (Observational measure of anxiety in five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents); Total range 0 to 100 with higher scores indicating greater anxiety) | (Day 0 + 15 minutes on average from initial baseline) On entering the OR |
| Perioperative Pediatric Anxiety (Change From Baseline) | Modified Yale Preoperative Anxiety Scale (Observational measure of anxiety in five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents); Total range 0 to 100 with higher scores indicating greater anxiety) | (Day 0 + 30 minutes on average from initial baseline) During mask induction |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Parental Anxiety (Change From Baseline) | State-Trait Anxiety Inventory: Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety. Total range 20 to 80 with higher scores indicating greater anxiety. The value is a sum of trait and state anxiety. | (Day 0 + 45 minutes on average from initial baseline) After mask induction |
| Measure | Description | Time Frame |
|---|---|---|
| Anesthesia Length | Length of time that patient received anesthesia care. | (Day 0 + 120 minutes on average from initial baseline) After exiting the OR |
| Surgery Length | Length of surgery from procedure start to procedure finish |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Jung | UCSF Medical Center | Principal Investigator |
| Jina Sinskey, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Benioff Children's Hospital | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32618627 | Derived | Jung MJ, Libaw JS, Ma K, Whitlock EL, Feiner JR, Sinskey JL. Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial. Anesth Analg. 2021 Mar 1;132(3):798-806. doi: 10.1213/ANE.0000000000005004. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Perioperative Virtual Reality Headset | Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software) with routine anesthetic care |
| FG001 | Control | Routine anesthetic care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Perioperative Virtual Reality Headset | Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software) with routine anesthetic care |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Perioperative Pediatric Anxiety (Change From Baseline) | Modified Yale Preoperative Anxiety Scale (Observational measure of anxiety in five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents); Total range 0 to 100 with higher scores indicating greater anxiety) | Posted | Median | Inter-Quartile Range | units on a scale | (Day 0 + 15 minutes on average from initial baseline) On entering the OR |
|
Adverse event data were collected throughout the perioperative period, generally ranging 2-4 hours after intervention or routine anesthetic induction.
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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 | Perioperative Virtual Reality Headset | Perioperative virtual reality headset with mobile app and routine anesthetic care |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jina Sinskey | University of California, San Francisco | 857-998-0137 | jina.sinskey@ucsf.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 | Aug 22, 2018 | Apr 7, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Induction Compliance Checklist | Induction Compliance Checklist (An observational scale used to describe the compliance of a child during induction of anesthesia, range 0 to 11 with higher scores indicating less compliance) | (Day 0 + 30 minutes on average from initial baseline) During mask induction |
| Parental Satisfaction | 21-item parental satisfaction questionnaire after induction of general anesthesia (T3). Parental satisfaction score range: 21-84. Higher scores represent higher satisfaction. | (Day 0 + 45 minutes on average from initial baseline) After mask induction |
| (Day 0 + 120 minutes on average from initial baseline) After exiting the OR |
| Pre-medication Given | Whether patient was given anxiolytic medication prior to induction of general anesthesia | (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia |
| Parent Present for Induction | Whether parent was present in operating room during induction of anesthesia | (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia |
Routine anesthetic care
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| ASA physical status classification | The ASA Physical Status Classification System is used to assess and communicate a patient's pre-anesthesia medical co-morbidities. ASA I is the healthiest and ASA VI is a declared brain-dead patient.
| Count of Participants | Participants |
|
| Prior general anesthesia | Count of Participants | Participants |
|
| Number of prior general anesthetics | Mean | Standard Deviation | Prior general anesthetics |
|
| Modified Yale Preoperative Anxiety Scale in preop | mYPAS is an observational measure of children's preoperative anxiety consisting of 27 items divided into 5 categories: Activity, Vocalizations, Emotional Expressivity, State of Arousal and Use of Parent. Scores range from 22.5 to 100 with higher scores indicating greater anxiety. | Median | Inter-Quartile Range | units on a scale |
|
| Parental State-Trait Anxiety Inventory in preop | State-Trait Anxiety Inventory: Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety. Range 20 to 80 with higher scores indicating greater anxiety. | Median | Inter-Quartile Range | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Perioperative Pediatric Anxiety (Change From Baseline) | Modified Yale Preoperative Anxiety Scale (Observational measure of anxiety in five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents); Total range 0 to 100 with higher scores indicating greater anxiety) | Posted | Median | Inter-Quartile Range | units on a scale | (Day 0 + 30 minutes on average from initial baseline) During mask induction |
|
|
|
| Secondary | Perioperative Parental Anxiety (Change From Baseline) | State-Trait Anxiety Inventory: Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety. Total range 20 to 80 with higher scores indicating greater anxiety. The value is a sum of trait and state anxiety. | Posted | Median | Inter-Quartile Range | units on a scale | (Day 0 + 45 minutes on average from initial baseline) After mask induction |
|
|
|
| Secondary | Induction Compliance Checklist | Induction Compliance Checklist (An observational scale used to describe the compliance of a child during induction of anesthesia, range 0 to 11 with higher scores indicating less compliance) | Posted | Median | Inter-Quartile Range | units on a scale | (Day 0 + 30 minutes on average from initial baseline) During mask induction |
|
|
|
| Secondary | Parental Satisfaction | 21-item parental satisfaction questionnaire after induction of general anesthesia (T3). Parental satisfaction score range: 21-84. Higher scores represent higher satisfaction. | Posted | Median | Inter-Quartile Range | units on a scale | (Day 0 + 45 minutes on average from initial baseline) After mask induction |
|
|
|
| Other Pre-specified | Anesthesia Length | Length of time that patient received anesthesia care. | Posted | Mean | Standard Deviation | minutes | (Day 0 + 120 minutes on average from initial baseline) After exiting the OR |
|
|
|
| Other Pre-specified | Surgery Length | Length of surgery from procedure start to procedure finish | Posted | Mean | Standard Deviation | Minutes | (Day 0 + 120 minutes on average from initial baseline) After exiting the OR |
|
|
|
| Other Pre-specified | Pre-medication Given | Whether patient was given anxiolytic medication prior to induction of general anesthesia | Posted | Count of Participants | Participants | (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia |
|
|
|
| Other Pre-specified | Parent Present for Induction | Whether parent was present in operating room during induction of anesthesia | Posted | Count of Participants | Participants | (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Control | Routine anesthetic care | 0 | 37 | 0 | 37 | 0 | 37 |
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