Feasibility of an Immersive Virtual Reality Intervention for First Trimester D&C: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants Able to Use VR Device Throughout the Entire Duration of First Trimester Surgical Abortion.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 or over
- •Elective surgical abortion under local anesthesia
- •English speaker
排除标准
- •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
研究组 & 干预措施
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.
干预措施: applied VR headset (Device)
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.
结局指标
主要结局
Number of Participants Able to Use VR Device Throughout the Entire Duration of First Trimester Surgical Abortion.
时间窗: 15 minutes
Number of participants able to use VR device throughout the entire duration of first trimester surgical abortion.
次要结局
- Change in Procedure Related Anxiety as Assessed by the Visual Analog Scale (VAS).(30 min)
研究者
Aparna Sridhar, MD, MPH, FACOG
Assistant Professor in Obstetrics and Gynecology at David Geffen School of Medicine at UCLA
University of California, Los Angeles