Virtual Reality Experience in First Trimester D&C

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: First Trimester Abortion; Virtual Reality

Treatments: Device: applied VR headset

Study type: Interventional

Funder types: Other

Identifiers

NCT03533036

IRB#17-001122

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Virtual Reality Intervention

Experimental group

Description:

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.

Treatment:

Device: applied VR headset

Control arm

No Intervention group

Description:

In the control group, participants will not use virtual reality during the procedure. Patients in the control arm will complete surveys evaluating procedure-related anxiety. These will be administered before and after the procedure.