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Clinical Trials/NCT03533036
NCT03533036
Completed
Not Applicable

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

University of California, Los Angeles1 site in 1 country30 target enrollmentDecember 13, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
First Trimester Abortion
Sponsor
University of California, Los Angeles
Enrollment
30
Locations
1
Primary Endpoint
Number of Participants Able to Use VR Device Throughout the Entire Duration of First Trimester Surgical Abortion.
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 13, 2017
End Date
September 30, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aparna Sridhar, MD, MPH, FACOG

Assistant Professor in Obstetrics and Gynecology at David Geffen School of Medicine at UCLA

University of California, Los Angeles

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Change in Procedure Related Anxiety as Assessed by the Visual Analog Scale (VAS).(30 min)

Study Sites (1)

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