Virtual Reality Experience in First Trimester D&C

• ClinicalTrials.gov Identifier: NCT03533036
• Recruitment Status: Completed
• First Posted: May 22, 2018
• Results First Posted: October 4, 2019
• Last Update Posted: October 4, 2019
• Sponsor: University of California, Los Angeles
• Collaborator: Society of Family Planning
• Information provided by (Responsible Party): Aparna Sridhar, MD, MPH, FACOG, University of California, Los Angeles

Study Description

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.

Condition or disease	Intervention/treatment	Phase
First Trimester Abortion; Virtual Reality	Device: applied VR headset	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Time series study with 15 controls and 15 experimental group. Investigators plan to enroll 30 patients in order to obtain an effect size for future studies. The mean and standard deviation of anxiety scores for each group will be used to calculate power for future studies.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Feasibility of an Immersive Virtual Reality Intervention for First Trimester D&C: A Pilot Study
• Actual Study Start Date: December 13, 2017
• Actual Primary Completion Date: September 18, 2018
• Actual Study Completion Date: September 30, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Patients must be biologically female, willing to have a first trimester abortion
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, California

University of California Los Angeles Obstetrics and Gynecology Clinic

Los Angeles, California, United States, 90024

Sponsors and Collaborators

University of California, Los Angeles

Society of Family Planning

  Study Documents (Full-Text)

Documents provided by Aparna Sridhar, MD, MPH, FACOG, University of California, Los Angeles:

Study Protocol and Statistical Analysis Plan  [PDF] December 13, 2017

More Information

Publications:

Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BM. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801.

Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 Jun;265(6):1068-1073. doi: 10.1097/SLA.0000000000002094.

Shourab NJ, Zagami SE, Golmakhani N, Mazlom SR, Nahvi A, Pabarja F, Talebi M, Rizi SM. Virtual reality and anxiety in primiparous women during episiotomy repair. Iran J Nurs Midwifery Res. 2016 Sep-Oct;21(5):521-526.

• Responsible Party: Aparna Sridhar, MD, MPH, FACOG, Assistant Professor in Obstetrics and Gynecology at David Geffen School of Medicine at UCLA, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03533036
• Other Study ID Numbers: IRB#17-001122
• First Posted: May 22, 2018
• Results First Posted: October 4, 2019
• Last Update Posted: October 4, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Aparna Sridhar, MD, MPH, FACOG, University of California, Los Angeles:

Virtual Reality; Anxiety