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OpenTrials
Completed

NCT Number: NCT03533036

Virtual Reality Experience in First Trimester D&C

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.

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Key information

Conditions

First Trimester Abortion Anxiety Disorders Mental Disorders Virtual Reality

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California Los Angeles Obstetrics and Gynecology Clinic

Los Angeles, California, 90024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

applied VR headset

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 22, 2018
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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