Virtual Reality Experience in First Trimester D&C
- Conditions
- First Trimester AbortionVirtual Reality
- Interventions
- Device: applied VR headset
- Registration Number
- NCT03533036
- Lead Sponsor
- University of California, Los Angeles
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
- Age 18 or over
- Elective surgical abortion under local anesthesia
- English speaker
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual Reality Intervention applied VR headset VR headsets consist of a Samsung phone dedicated to playing programs designed by the AppliedVR company. The phone is inserted in the front of the headset and can play videos that can be then viewed by the participant while wearing the headset. Participants in the experimental arm will be fitted with VR headsets prior to first trimester abortion and will wear the headset during the procedure. Participants will be able to choose a program of their preference (ex. guided meditation, beautiful scenery). The patient may remove the VR device at any time during the procedure. After the procedure, investigators will carry out a qualitative interview with the participant and ask about the experience of using the VR headset during first trimester abortion. Patients will also complete surveys evaluating procedure-related anxiety. These will be administered before and after the procedure.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
University of California Los Angeles Obstetrics and Gynecology Clinic
🇺🇸Los Angeles, California, United States