Anxiety
Conditions
Keywords
Virtual Reality, Pediatric Anesthesia
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPerioperative virtual reality headset with mobile app
Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software)
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 5-12 years * Patients present in preoperative area for induction of general anesthesia for an elective surgery or procedure
Exclusion criteria
* Patients with injuries to the head/face that would prohibit wearing of headsets * Patients with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma * Patients with open skin, lice, scabies, or other infectious skin conditions on the head/face * Patients with a history of or current symptoms of vertigo * Patients who are blind * Patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver * Patients on whom the VR headset does not fit appropriately * Non-English speaking patients (due to limited availability of non-English study documents and consents)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Pediatric Anxiety (Change From Baseline) | (Day 0 + 15 minutes on average from initial baseline) On entering the OR | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Parental Anxiety (Change From Baseline) | (Day 0 + 45 minutes on average from initial baseline) After mask induction | 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. |
| Induction Compliance Checklist | (Day 0 + 30 minutes on average from initial baseline) During mask induction | 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) |
| Parental Satisfaction | (Day 0 + 45 minutes on average from initial baseline) After mask induction | 21-item parental satisfaction questionnaire after induction of general anesthesia (T3). Parental satisfaction score range: 21-84. Higher scores represent higher satisfaction. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anesthesia Length | (Day 0 + 120 minutes on average from initial baseline) After exiting the OR | Length of time that patient received anesthesia care. |
| Surgery Length | (Day 0 + 120 minutes on average from initial baseline) After exiting the OR | Length of surgery from procedure start to procedure finish |
| Pre-medication Given | (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia | Whether patient was given anxiolytic medication prior to induction of general anesthesia |
| Parent Present for Induction | (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia | Whether parent was present in operating room during induction of anesthesia |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Perioperative Virtual Reality Headset Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software) with routine anesthetic care | 34 |
| Control Routine anesthetic care | 37 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | hardware malfunction (battery depletion) | 1 | 0 |
Baseline characteristics
| Characteristic | Perioperative Virtual Reality Headset | Control | Total |
|---|---|---|---|
| Age, Continuous | 8.3 years STANDARD_DEVIATION 2.3 | 7.8 years STANDARD_DEVIATION 2.3 | 8.0 years STANDARD_DEVIATION 2.3 |
| ASA physical status classification ASA 1 | 11 Participants | 15 Participants | 26 Participants |
| ASA physical status classification ASA 2 | 16 Participants | 18 Participants | 34 Participants |
| ASA physical status classification ASA 3 | 7 Participants | 4 Participants | 11 Participants |
| BMI | 18.5 kg/m^2 STANDARD_DEVIATION 4 | 18.0 kg/m^2 STANDARD_DEVIATION 4.8 | 18.2 kg/m^2 STANDARD_DEVIATION 4.4 |
| Height | 131.8 cm STANDARD_DEVIATION 12.8 | 130.2 cm STANDARD_DEVIATION 15.5 | 131.0 cm STANDARD_DEVIATION 14.2 |
| Modified Yale Preoperative Anxiety Scale in preop | 28.3 units on a scale | 28.3 units on a scale | 28.3 units on a scale |
| Number of prior general anesthetics | 3.3 Prior general anesthetics STANDARD_DEVIATION 4.1 | 2.7 Prior general anesthetics STANDARD_DEVIATION 5.2 | 3.0 Prior general anesthetics STANDARD_DEVIATION 4.7 |
| Parental State-Trait Anxiety Inventory in preop | 36.0 units on a scale | 38.0 units on a scale | 36.0 units on a scale |
| Prior general anesthesia No | 15 Participants | 19 Participants | 34 Participants |
| Prior general anesthesia Yes | 19 Participants | 18 Participants | 37 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 11 Participants | 17 Participants |
| Race (NIH/OMB) White | 20 Participants | 19 Participants | 39 Participants |
| Region of Enrollment United States | 34 participants | 37 participants | 71 participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Male | 16 Participants | 19 Participants | 35 Participants |
| Weight | 32.9 kg STANDARD_DEVIATION 11.9 | 31.9 kg STANDARD_DEVIATION 15.2 | 32.4 kg STANDARD_DEVIATION 13.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 37 |
| other Total, other adverse events | 0 / 33 | 0 / 37 |
| serious Total, serious adverse events | 0 / 33 | 0 / 37 |
Outcome results
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)
Time frame: (Day 0 + 30 minutes on average from initial baseline) During mask induction
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Perioperative Virtual Reality Headset | Perioperative Pediatric Anxiety (Change From Baseline) | 0.0 units on a scale |
| Control | Perioperative Pediatric Anxiety (Change From Baseline) | 13.3 units on a scale |
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)
Time frame: (Day 0 + 15 minutes on average from initial baseline) On entering the OR
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Perioperative Virtual Reality Headset | Perioperative Pediatric Anxiety (Change From Baseline) | 0.0 units on a scale |
| Control | Perioperative Pediatric Anxiety (Change From Baseline) | 5.0 units on a scale |
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)
Time frame: (Day 0 + 30 minutes on average from initial baseline) During mask induction
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Perioperative Virtual Reality Headset | Induction Compliance Checklist | 0 units on a scale |
| Control | Induction Compliance Checklist | 0 units on a scale |
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.
Time frame: (Day 0 + 45 minutes on average from initial baseline) After mask induction
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Perioperative Virtual Reality Headset | Parental Satisfaction | 83 units on a scale |
| Control | Parental Satisfaction | 80 units on a scale |
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.
Time frame: (Day 0 + 45 minutes on average from initial baseline) After mask induction
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Perioperative Virtual Reality Headset | Perioperative Parental Anxiety (Change From Baseline) | 0 units on a scale |
| Control | Perioperative Parental Anxiety (Change From Baseline) | 0 units on a scale |
Other Pre-specified
Anesthesia Length
Length of time that patient received anesthesia care.
Time frame: (Day 0 + 120 minutes on average from initial baseline) After exiting the OR
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perioperative Virtual Reality Headset | Anesthesia Length | 80 minutes | Standard Deviation 91 |
| Control | Anesthesia Length | 101 minutes | Standard Deviation 119 |
Other Pre-specified
Parent Present for Induction
Whether parent was present in operating room during induction of anesthesia
Time frame: (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Perioperative Virtual Reality Headset | Parent Present for Induction | Yes | 30 Participants |
| Perioperative Virtual Reality Headset | Parent Present for Induction | No | 4 Participants |
| Control | Parent Present for Induction | Yes | 35 Participants |
| Control | Parent Present for Induction | No | 2 Participants |
Other Pre-specified
Pre-medication Given
Whether patient was given anxiolytic medication prior to induction of general anesthesia
Time frame: (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Perioperative Virtual Reality Headset | Pre-medication Given | Yes | 0 Participants |
| Perioperative Virtual Reality Headset | Pre-medication Given | No | 34 Participants |
| Control | Pre-medication Given | Yes | 0 Participants |
| Control | Pre-medication Given | No | 37 Participants |
Other Pre-specified
Surgery Length
Length of surgery from procedure start to procedure finish
Time frame: (Day 0 + 120 minutes on average from initial baseline) After exiting the OR
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perioperative Virtual Reality Headset | Surgery Length | 62 Minutes | Standard Deviation 85 |
| Control | Surgery Length | 77 Minutes | Standard Deviation 106 |