NCT03533036

Virtual Reality Experience in First Trimester D&C

Feasibility of an Immersive Virtual Reality Intervention for First Trimester D&C: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• First Trimester Abortion
• Virtual Reality

Interventions

Type	Name	Description
DEVICE	applied 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.

Timeline

• Start date: 2017-12-13
• Primary completion: 2018-09-18
• Completion: 2018-09-30
• First posted: 2018-05-22
• Last updated: 2019-10-04
• Results posted: 2019-10-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study