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First Trimester AbortionNCT03533036

Virtual Reality Experience in First Trimester D&C

A study testing applied VR headset in people with First Trimester Abortion and Virtual Reality, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
First Trimester Abortion, Virtual Reality
What is being tested?
applied VR headset
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
13 Dec 2017to 30 Sep 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California Los Angeles Obstetrics and Gynecology Clinic

    Los Angeles, California, 90024

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
applied VR headset
Keywords
Virtual Reality, Anxiety
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • applied VR headsetDevice

    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.

Study groups in NCT03533036
Study groupRoleWhat they receive
Virtual Reality InterventionExperimentalVR 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.
Receives: Device: applied VR headset
Control armNo interventionIn 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 15 minutes

Secondary outcomes (1)

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

    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.

    Measured: 30 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2018
  2. Study start13 Dec 2017
  3. Primary completion18 Sep 2018
  4. Study completion30 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03533036
Sponsor's protocol ID
IRB#17-001122
Status last verified
Oct 2019
First submitted
12 Mar 2018
Last updated
4 Oct 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 27349654

  • 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.

    PubMed 27906757

  • 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.

    PubMed 27904638

Questions about this trial

What is this clinical trial studying?

A study testing applied VR headset in people with First Trimester Abortion and Virtual Reality, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Able to Use VR Device Throughout the Entire Duration of First Trimester Surgical Abortion. (time frame: 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03533036, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019; AzTrials last refreshed its copy on 27 Oct 2026.

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