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NCT03533036

Virtual Reality Experience in First Trimester D&C

Completed NA Results posted Last updated 4 October 2019
What this trial tests

NA trial testing applied VR headset in First Trimester Abortion in 30 participants. Completed in 30 September 2018.

Timeline
13 December 2017
Primary endpoint
18 September 2018
30 September 2018

Quick facts

Lead sponsorUniversity of California, Los Angeles
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeother
Enrollment30
Start date13 December 2017
Primary completion18 September 2018
Estimated completion30 September 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Los Angeles

Who can join

18 and older, female only, with First Trimester Abortion or Virtual Reality. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Able to Use VR Device Throughout the Entire Duration of First Trimester Surgical Abortion. Primary · 15 minutes

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

GroupValue95% CI
Virtual Reality Intervention6
Change in Procedure Related Anxiety as Assessed by the Visual Analog Scale (VAS). Secondary · 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.

GroupValue95% CI
Virtual Reality Intervention-3.97± 3.20
Control Arm-2.71± 2.89

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for First Trimester Abortion

Currently open trials in the same condition.

Other University of California, Los Angeles trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03533036.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing