Virtual Reality Experience in First Trimester D&C

NCT03533036 | Completed Results FDA Device

• 1 other identifier: IRB#17-001122
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

First Trimester Abortion; Virtual Reality

Keywords

Virtual Reality; Anxiety

Outcome Measures

Primary Outcomes (1)

• Number of Participants Able to Use VR Device Throughout the Entire Duration of First Trimester Surgical Abortion.

  Number of participants able to use VR device throughout the entire duration of first trimester surgical abortion.

  15 minutes

Secondary Outcomes (1)

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

  30 min

Study Arms (2)

Virtual Reality Intervention

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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.

Interventions

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.

Virtual Reality Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients must be biologically female, willing to have a first trimester abortion
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or over
• Elective surgical abortion under local anesthesia
• English speaker

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Society of Family Planning: collaborator

Study Sites (1)

University of California Los Angeles Obstetrics and Gynecology Clinic

Los Angeles, California, 90024, United States

Location

Related Publications (3)

• 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.

  PMID: 27349654 BACKGROUND

• 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.

  PMID: 27906757 BACKGROUND

• 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. doi: 10.4103/1735-9066.193417.

  PMID: 27904638 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Dr. Aparna Sridhar, Associate Clinical Professor
• Organization: UCLA

asridhar@mednet.ucla.edu

3107947274

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Obstetrics and Gynecology at David Geffen School of Medicine at UCLA

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: May 22, 2018
• Study Start: December 13, 2017
• Primary Completion: September 18, 2018
• Study Completion: September 30, 2018
• Last Updated: October 4, 2019
• Results First Posted: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)