Virtual Reality Experience in First Trimester D&C

October 2, 2019 updated by: Aparna Sridhar, MD, MPH, FACOG, University of California, Los Angeles

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • University of California Los Angeles Obstetrics and Gynecology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Intervention
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.
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.
No Intervention: Control arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Able to Use VR Device Throughout the Entire Duration of First Trimester Surgical Abortion.
Time Frame: 15 minutes
Number of participants able to use VR device throughout the entire duration of first trimester surgical abortion.
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Procedure Related Anxiety as Assessed by the Visual Analog Scale (VAS).
Time Frame: 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.
30 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

Society of Family Planning

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2017

Primary Completion (Actual)

September 18, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

May 9, 2018

First Posted (Actual)

May 22, 2018

Study Record Updates

Last Update Posted (Actual)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB#17-001122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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