Trial Outcomes & Findings for Perioperative Virtual Reality for Pediatric Anesthesia (NCT NCT03583450)
NCT ID: NCT03583450
Last Updated: 2020-07-08
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
(Day 0 + 15 minutes on average from initial baseline) On entering the OR
Results posted on
2020-07-08
Participant Flow
Participant milestones
| Measure |
Perioperative Virtual Reality Headset
Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software) with routine anesthetic care
|
Control
Routine anesthetic care
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
37
|
|
Overall Study
COMPLETED
|
33
|
37
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Perioperative Virtual Reality Headset
Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software) with routine anesthetic care
|
Control
Routine anesthetic care
|
|---|---|---|
|
Overall Study
hardware malfunction (battery depletion)
|
1
|
0
|
Baseline Characteristics
Perioperative Virtual Reality for Pediatric Anesthesia
Baseline characteristics by cohort
| Measure |
Perioperative Virtual Reality Headset
n=34 Participants
Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software) with routine anesthetic care
|
Control
n=37 Participants
Routine anesthetic care
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.3 years
STANDARD_DEVIATION 2.3 • n=99 Participants
|
7.8 years
STANDARD_DEVIATION 2.3 • n=107 Participants
|
8.0 years
STANDARD_DEVIATION 2.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=99 Participants
|
37 participants
n=107 Participants
|
71 participants
n=206 Participants
|
|
Height
|
131.8 cm
STANDARD_DEVIATION 12.8 • n=99 Participants
|
130.2 cm
STANDARD_DEVIATION 15.5 • n=107 Participants
|
131.0 cm
STANDARD_DEVIATION 14.2 • n=206 Participants
|
|
Weight
|
32.9 kg
STANDARD_DEVIATION 11.9 • n=99 Participants
|
31.9 kg
STANDARD_DEVIATION 15.2 • n=107 Participants
|
32.4 kg
STANDARD_DEVIATION 13.6 • n=206 Participants
|
|
BMI
|
18.5 kg/m^2
STANDARD_DEVIATION 4.0 • n=99 Participants
|
18.0 kg/m^2
STANDARD_DEVIATION 4.8 • n=107 Participants
|
18.2 kg/m^2
STANDARD_DEVIATION 4.4 • n=206 Participants
|
|
ASA physical status classification
ASA 1
|
11 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
ASA physical status classification
ASA 2
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
ASA physical status classification
ASA 3
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Prior general anesthesia
Yes
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Prior general anesthesia
No
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Number of prior general anesthetics
|
3.3 Prior general anesthetics
STANDARD_DEVIATION 4.1 • n=99 Participants
|
2.7 Prior general anesthetics
STANDARD_DEVIATION 5.2 • n=107 Participants
|
3.0 Prior general anesthetics
STANDARD_DEVIATION 4.7 • n=206 Participants
|
|
Modified Yale Preoperative Anxiety Scale in preop
|
28.3 units on a scale
n=99 Participants
|
28.3 units on a scale
n=107 Participants
|
28.3 units on a scale
n=206 Participants
|
|
Parental State-Trait Anxiety Inventory in preop
|
36.0 units on a scale
n=99 Participants
|
38.0 units on a scale
n=107 Participants
|
36.0 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: (Day 0 + 15 minutes on average from initial baseline) On entering the ORModified 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)
Outcome measures
| Measure |
Perioperative Virtual Reality Headset
n=33 Participants
Perioperative virtual reality headset with mobile app and routine anesthetic care
|
Control
n=37 Participants
Routine anesthetic care
|
|---|---|---|
|
Perioperative Pediatric Anxiety (Change From Baseline)
|
0.0 units on a scale
Interval 0.0 to 0.0
|
5.0 units on a scale
Interval 0.0 to 10.0
|
PRIMARY outcome
Timeframe: (Day 0 + 30 minutes on average from initial baseline) During mask inductionModified 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)
Outcome measures
| Measure |
Perioperative Virtual Reality Headset
n=33 Participants
Perioperative virtual reality headset with mobile app and routine anesthetic care
|
Control
n=37 Participants
Routine anesthetic care
|
|---|---|---|
|
Perioperative Pediatric Anxiety (Change From Baseline)
|
0.0 units on a scale
Interval 0.0 to 0.0
|
13.3 units on a scale
Interval 5.0 to 26.7
|
SECONDARY outcome
Timeframe: (Day 0 + 45 minutes on average from initial baseline) After mask inductionState-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.
Outcome measures
| Measure |
Perioperative Virtual Reality Headset
n=33 Participants
Perioperative virtual reality headset with mobile app and routine anesthetic care
|
Control
n=37 Participants
Routine anesthetic care
|
|---|---|---|
|
Perioperative Parental Anxiety (Change From Baseline)
|
0 units on a scale
Interval -3.0 to 3.0
|
0 units on a scale
Interval -3.0 to 3.0
|
SECONDARY outcome
Timeframe: (Day 0 + 30 minutes on average from initial baseline) During mask inductionInduction 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)
Outcome measures
| Measure |
Perioperative Virtual Reality Headset
n=33 Participants
Perioperative virtual reality headset with mobile app and routine anesthetic care
|
Control
n=37 Participants
Routine anesthetic care
|
|---|---|---|
|
Induction Compliance Checklist
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: (Day 0 + 45 minutes on average from initial baseline) After mask induction21-item parental satisfaction questionnaire after induction of general anesthesia (T3). Parental satisfaction score range: 21-84. Higher scores represent higher satisfaction.
Outcome measures
| Measure |
Perioperative Virtual Reality Headset
n=33 Participants
Perioperative virtual reality headset with mobile app and routine anesthetic care
|
Control
n=37 Participants
Routine anesthetic care
|
|---|---|---|
|
Parental Satisfaction
|
83 units on a scale
Interval 76.0 to 84.0
|
80 units on a scale
Interval 76.0 to 83.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: (Day 0 + 120 minutes on average from initial baseline) After exiting the ORLength of time that patient received anesthesia care.
Outcome measures
| Measure |
Perioperative Virtual Reality Headset
n=34 Participants
Perioperative virtual reality headset with mobile app and routine anesthetic care
|
Control
n=37 Participants
Routine anesthetic care
|
|---|---|---|
|
Anesthesia Length
|
80 minutes
Standard Deviation 91
|
101 minutes
Standard Deviation 119
|
OTHER_PRE_SPECIFIED outcome
Timeframe: (Day 0 + 120 minutes on average from initial baseline) After exiting the ORLength of surgery from procedure start to procedure finish
Outcome measures
| Measure |
Perioperative Virtual Reality Headset
n=34 Participants
Perioperative virtual reality headset with mobile app and routine anesthetic care
|
Control
n=37 Participants
Routine anesthetic care
|
|---|---|---|
|
Surgery Length
|
62 Minutes
Standard Deviation 85
|
77 Minutes
Standard Deviation 106
|
OTHER_PRE_SPECIFIED outcome
Timeframe: (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesiaWhether patient was given anxiolytic medication prior to induction of general anesthesia
Outcome measures
| Measure |
Perioperative Virtual Reality Headset
n=34 Participants
Perioperative virtual reality headset with mobile app and routine anesthetic care
|
Control
n=37 Participants
Routine anesthetic care
|
|---|---|---|
|
Pre-medication Given
Yes
|
0 Participants
|
0 Participants
|
|
Pre-medication Given
No
|
34 Participants
|
37 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesiaWhether parent was present in operating room during induction of anesthesia
Outcome measures
| Measure |
Perioperative Virtual Reality Headset
n=34 Participants
Perioperative virtual reality headset with mobile app and routine anesthetic care
|
Control
n=37 Participants
Routine anesthetic care
|
|---|---|---|
|
Parent Present for Induction
No
|
4 Participants
|
2 Participants
|
|
Parent Present for Induction
Yes
|
30 Participants
|
35 Participants
|
Adverse Events
Perioperative Virtual Reality Headset
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Dr. Jina Sinskey
University of California, San Francisco
Phone: 857-998-0137
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place