First Trimester Abortion, Virtual Reality
Conditions
Keywords
Virtual Reality, Anxiety
Brief summary
Virtual reality (VR) has been used in health care settings to decrease anxiety and pain. This project is a feasibility study to evaluate whether virtual reality can be used in the setting of a first trimester pregnancy termination by D&C and whether the use of virtual reality (VR) headsets can help decrease anxiety for patients during this procedure.
Detailed description
The investigators will assess the practicality and qualitative experience of women using VR during first trimester surgical abortion under local anesthesia. Semi-structured interviews will be conducted to understand the patient's experience of using VR. Surveys evaluating anxiety will be administered to women before and after surgical abortion. Investigators plan to enroll 30 patients in order to obtain an effect size for future studies. A group of control patients will be enrolled; these patients will receive standard care and will be compared to the anxiety scores of the group receiving VR. The mean and standard deviation of anxiety scores for each group will be used to calculate power for future studies.
Interventions
DEVICEapplied VR headset
Virtual reality (VR) is a three-dimensional experience created by a headset fitted with a video display. The device, designed to be worn on the face, immerses the viewer in a virtual world and can create a visual distraction from the patient's present situation. We will use a commercially available VR device, comprised of a phone and headset. The phone is inserted into the headset to act as the visual display that can create three dimensional environments. The patient will then choose the virtual reality experience she prefers from the two relaxation programs available. The VR device will be introduced to the participant and fitted to her head prior to the procedure. The device is intended to be worn during the full length of the procedure until the conclusion of the D&C, however the participant may decide to stop wearing the device and choose to end the VR experience at any time.
Sponsors
Society of Family Planning
University of California, Los Angeles
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Time series study with 15 controls and 15 experimental group. Investigators plan to enroll 30 patients in order to obtain an effect size for future studies. The mean and standard deviation of anxiety scores for each group will be used to calculate power for future studies.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 or over * Elective surgical abortion under local anesthesia * English speaker
Exclusion criteria
* No psychiatric history * No history of motion sickness or vertigo * No history of seizures or epilepsy * No recent eye surgery or visual impairment * No claustrophobia. * No current nausea or vomiting * Not on seizure-threshold lowering medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Able to Use VR Device Throughout the Entire Duration of First Trimester Surgical Abortion. | 15 minutes | Number of participants able to use VR device throughout the entire duration of first trimester surgical abortion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Procedure Related Anxiety as Assessed by the Visual Analog Scale (VAS). | 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. |
Countries
United States
Participant flow
Recruitment details
15 participants recruited to each group (experimental vs control)
Pre-assignment details
Patients were assigned to either experimental or control group via convenient sampling.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Control Arm In the control group, participants did not use virtual reality during the procedure. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Control Arm | Total | Virtual Reality Intervention |
|---|---|---|---|
| Age, Continuous | 31 years STANDARD_DEVIATION 7.8 | 30 years STANDARD_DEVIATION 7.4 | 29 years STANDARD_DEVIATION 6.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 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 | 5 Participants |
| Race (NIH/OMB) White | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Female | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Number of Participants Able to Use VR Device Throughout the Entire Duration of First Trimester Surgical Abortion.
Number of participants able to use VR device throughout the entire duration of first trimester surgical abortion.
Time frame: 15 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Virtual Reality Intervention | Number of Participants Able to Use VR Device Throughout the Entire Duration of First Trimester Surgical Abortion. | 6 participants |
Secondary
Change in Procedure Related Anxiety as Assessed by the Visual Analog Scale (VAS).
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.
Time frame: 30 min
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Intervention | Change in Procedure Related Anxiety as Assessed by the Visual Analog Scale (VAS). | -3.97 units on a scale | Standard Deviation 3.2 |
| Control Arm | Change in Procedure Related Anxiety as Assessed by the Visual Analog Scale (VAS). | -2.71 units on a scale | Standard Deviation 2.89 |