Trial Outcomes & Findings for Virtual Reality by Mobile Phone: Improving Child Pedestrian Safety (NCT NCT02948400)
NCT ID: NCT02948400
Last Updated: 2024-01-31
Results Overview
risky crossings in virtual environment setting, indicated by hits/close calls while crossing virtual street
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
500 participants
Primary outcome timeframe
3.5 months after baseline (about 1 week after completion of all training)
Results posted on
2024-01-31
Participant Flow
21 participants were excluded prior to randomization, for the following reasons: COVID-related research closure: 2 Child discovered to be wrong age (ineligible): 5 Child unable to understand protocol: 1 Sibling discovered to be in study previously (ineligible): 3 Motion sickness in virtual reality: 1 Participant withdrew for unknown reasons: 9
Participant milestones
| Measure |
Google Cardboard Virtual Environment
pedestrian safety training using the Google Cardboard device and delivery of a pedestrian virtual environment by mobile smartphone. Note that children in this arm will be trained using an immersive virtual environment delivered by smartphone, which is different from the other arm that is trained using a semi-immersive virtual environment delivered in a kiosk. The intervention is pedestrian safety training for both arms.
pedestrian safety training in pedestrian virtual environment: pedestrian safety training
|
Semi-immersive Virtual Environment
pedestrian safety training using a semi-immersive virtual pedestrian environment kiosk. Note that children in this arm will be trained using a semi-immersive virtual environment delivered in a kiosk, which is different from the other arm that is trained using an immersive virtual environment delivered by smartphone. The intervention is pedestrian safety training for both arms.
pedestrian safety training in pedestrian virtual environment: pedestrian safety training
|
|---|---|---|
|
Overall Study
STARTED
|
254
|
225
|
|
Overall Study
COMPLETED
|
181
|
179
|
|
Overall Study
NOT COMPLETED
|
73
|
46
|
Reasons for withdrawal
| Measure |
Google Cardboard Virtual Environment
pedestrian safety training using the Google Cardboard device and delivery of a pedestrian virtual environment by mobile smartphone. Note that children in this arm will be trained using an immersive virtual environment delivered by smartphone, which is different from the other arm that is trained using a semi-immersive virtual environment delivered in a kiosk. The intervention is pedestrian safety training for both arms.
pedestrian safety training in pedestrian virtual environment: pedestrian safety training
|
Semi-immersive Virtual Environment
pedestrian safety training using a semi-immersive virtual pedestrian environment kiosk. Note that children in this arm will be trained using a semi-immersive virtual environment delivered in a kiosk, which is different from the other arm that is trained using an immersive virtual environment delivered by smartphone. The intervention is pedestrian safety training for both arms.
pedestrian safety training in pedestrian virtual environment: pedestrian safety training
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
17
|
10
|
|
Overall Study
failed to attend appointments
|
47
|
34
|
|
Overall Study
COVID-related closure
|
6
|
2
|
|
Overall Study
sibling discovered to be in study so participant ineligible
|
1
|
0
|
|
Overall Study
motion sickness in virtual reality
|
2
|
0
|
Baseline Characteristics
Virtual Reality by Mobile Phone: Improving Child Pedestrian Safety
Baseline characteristics by cohort
| Measure |
Google Cardboard Virtual Environment
n=254 Participants
pedestrian safety training using the Google Cardboard device and delivery of a pedestrian virtual environment by mobile smartphone. Note that children in this arm will be trained using an immersive virtual environment delivered by smartphone, which is different from the other arm that is trained using a semi-immersive virtual environment delivered in a kiosk. The intervention is pedestrian safety training for both arms.
pedestrian safety training in pedestrian virtual environment: pedestrian safety training
|
Semi-immersive Virtual Environment
n=225 Participants
pedestrian safety training using a semi-immersive virtual pedestrian environment kiosk. Note that children in this arm will be trained using a semi-immersive virtual environment delivered in a kiosk, which is different from the other arm that is trained using an immersive virtual environment delivered by smartphone. The intervention is pedestrian safety training for both arms.
pedestrian safety training in pedestrian virtual environment: pedestrian safety training
|
Total
n=479 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.5 years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
7.4 years
STANDARD_DEVIATION 0.5 • n=7 Participants
|
7.5 years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
139 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
243 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
458 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
132 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
99 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
254 participants
n=5 Participants
|
225 participants
n=7 Participants
|
479 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3.5 months after baseline (about 1 week after completion of all training)Population: Participants who completed study protocol, as described in participant flow section
risky crossings in virtual environment setting, indicated by hits/close calls while crossing virtual street
Outcome measures
| Measure |
Google Cardboard Virtual Environment
n=181 Participants
pedestrian safety training using the Google Cardboard device and delivery of a pedestrian virtual environment by mobile smartphone. Note that children in this arm will be trained using an immersive virtual environment delivered by smartphone, which is different from the other arm that is trained using a semi-immersive virtual environment delivered in a kiosk. The intervention is pedestrian safety training for both arms.
pedestrian safety training in pedestrian virtual environment: pedestrian safety training
|
Semi-immersive Virtual Environment
n=179 Participants
pedestrian safety training using a semi-immersive virtual pedestrian environment kiosk. Note that children in this arm will be trained using a semi-immersive virtual environment delivered in a kiosk, which is different from the other arm that is trained using an immersive virtual environment delivered by smartphone. The intervention is pedestrian safety training for both arms.
pedestrian safety training in pedestrian virtual environment: pedestrian safety training
|
|---|---|---|
|
Risky Crossings
|
.20 count of risky crossings
Standard Deviation .11
|
.13 count of risky crossings
Standard Deviation .091
|
Adverse Events
Google Cardboard Virtual Environment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Semi-immersive Virtual Environment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Google Cardboard Virtual Environment
n=254 participants at risk
pedestrian safety training using the Google Cardboard device and delivery of a pedestrian virtual environment by mobile smartphone. Note that children in this arm will be trained using an immersive virtual environment delivered by smartphone, which is different from the other arm that is trained using a semi-immersive virtual environment delivered in a kiosk. The intervention is pedestrian safety training for both arms.
pedestrian safety training in pedestrian virtual environment: pedestrian safety training
|
Semi-immersive Virtual Environment
n=225 participants at risk
pedestrian safety training using a semi-immersive virtual pedestrian environment kiosk. Note that children in this arm will be trained using a semi-immersive virtual environment delivered in a kiosk, which is different from the other arm that is trained using an immersive virtual environment delivered by smartphone. The intervention is pedestrian safety training for both arms.
pedestrian safety training in pedestrian virtual environment: pedestrian safety training
|
|---|---|---|
|
Nervous system disorders
motion sickness
|
0.39%
1/254 • Number of events 1 • During participation in the study, about 6 months for each participant.
The definition matches that in clinicaltrials.gov and requirements of our university IRB.
|
0.00%
0/225 • During participation in the study, about 6 months for each participant.
The definition matches that in clinicaltrials.gov and requirements of our university IRB.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place