Trial Outcomes & Findings for Virtual Reality Experience in First Trimester D&C (NCT NCT03533036)

NCT ID: NCT03533036

Last Updated: 2019-10-04

Results Overview

Number of participants able to use VR device throughout the entire duration of first trimester surgical abortion.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

15 minutes

Results posted on

2019-10-04

Participant Flow

15 participants recruited to each group (experimental vs control)

Patients were assigned to either experimental or control group via convenient sampling.

Participant milestones

Participant milestones
Measure	Virtual Reality Intervention Participants in the experimental arm were fitted with VR headsets prior to first trimester abortion and could choose to wear the headset during the procedure. Participants chose a program of their preference (ex. guided meditation, beautiful scenery). The patient was able to remove the VR device at any time during the procedure.	Control Arm In the control group, participants did not use virtual reality during the procedure.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Virtual Reality Experience in First Trimester D&C

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Reality Intervention n=15 Participants Participants in the experimental arm were fitted with VR headsets prior to first trimester abortion and could choose to wear the headset during the procedure. Participants chose a program of their preference (ex. guided meditation, beautiful scenery). The patient was able to remove the VR device at any time during the procedure.	Control Arm n=15 Participants In the control group, participants did not use virtual reality during the procedure.	Total n=30 Participants Total of all reporting groups
Age, Continuous	29 years STANDARD_DEVIATION 6.9 • n=5 Participants	31 years STANDARD_DEVIATION 7.8 • n=7 Participants	30 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 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	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes

Number of participants able to use VR device throughout the entire duration of first trimester surgical abortion.

Outcome measures

Outcome measures
Measure	Virtual Reality Intervention n=15 Participants Participants in the experimental arm were fitted with VR headsets prior to first trimester abortion and could choose to wear the headset during the procedure. Participants chose a program of their preference (ex. guided meditation, beautiful scenery). The patient was able to remove the VR device at any time during the procedure.	Control Arm In the control group, participants did not use virtual reality during the procedure.
Number of Participants Able to Use VR Device Throughout the Entire Duration of First Trimester Surgical Abortion.	6 participants	—

SECONDARY outcome

Timeframe: 30 min

Mean change in procedure related anxiety score as assessed by the Visual Analog Scale (VAS). The Visual Analog Scale is a 11 point scale ranging from 0 to 10. 0 indicates the least amount of discomfort or anxiety whereas 10 represents the most amount of discomfort or anxiety. Participants were surveyed on their level of discomfort prior to and after the procedure. The difference of these scores was taken and the average of each group is presented in as a result.

Outcome measures

Outcome measures
Measure	Virtual Reality Intervention n=15 Participants Participants in the experimental arm were fitted with VR headsets prior to first trimester abortion and could choose to wear the headset during the procedure. Participants chose a program of their preference (ex. guided meditation, beautiful scenery). The patient was able to remove the VR device at any time during the procedure.	Control Arm n=15 Participants In the control group, participants did not use virtual reality during the procedure.
Change in Procedure Related Anxiety as Assessed by the Visual Analog Scale (VAS).	-3.97 units on a scale Standard Deviation 3.20	-2.71 units on a scale Standard Deviation 2.89

Adverse Events

Virtual Reality Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

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. Aparna Sridhar, Associate Clinical Professor

UCLA

Phone: 3107947274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place