Clinical trial NCT03533036: Virtual Reality Experience in First Trimester D&C
Official title: Feasibility of an Immersive Virtual Reality Intervention for First Trimester D&C: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: First Trimester Abortion
Virtual Reality
Keywords: Virtual Reality
Anxiety
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2018-05-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Number of Participants Able to Use VR Device Throughout the Entire Duration of First Trimester Surgical Abortion.
timeFrame: 15 minutes
Secondary outcomes:
measure: Change in Procedure Related Anxiety as Assessed by the Visual Analog Scale (VAS).
timeFrame: 30 min
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles Obstetrics and Gynecology Clinic
state: California
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.