Virtual Reality Experience in First Trimester D&C

Not Applicable

Completed

• Conditions: First Trimester Abortion; Virtual Reality

• 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.

Study Timeline

• Study Start: 2017-12-13
• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-05-09
• Study First Posted: 2018-05-22
• Primary Completion: 2018-09-18
• Study Completion: 2018-09-30
• Results First Submitted: 2019-09-12
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-02
• Last Update Submitted: 2019-10-02
• Results First Posted: 2019-10-04
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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