Virtual Reality as an Adjunctive Agent for the Management of Pain and Anxiety During First Trimester Procedural Abortion: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Pain scores during a first trimester procedural abortion
研究概览
简要总结
The goal of this clinical trial is to learn whether use of a virtual reality (VR) headset showing a meditative nature video will help reduce pain and anxiety during a first trimester procedural abortion. Investigators will enroll 72 patients undergoing a first trimester procedural abortion with usual care to manage pain and anxiety compared to use of a VR headset in addition to usual care to see if use of the VR headset will decrease pain and anxiety and increase satisfaction with the procedure.
详细描述
While procedural abortions are common outpatient procedures, providing optimal pain and anxiety relief during these procedures is challenging. With rapidly developing technological advances, virtual reality (VR) has emerged as a promising modality to help manage pain and anxiety control in the medical field, including obstetrics and gynecology. However, there are no studies evaluating the effect of VR on pain during a procedural abortion.
The goal of this randomized controlled trial is to primarily evaluate whether using a VR headset to display a meditative nature video as a noninvasive, low risk technology may reduce pain and anxiety for patients undergoing a first trimester procedural abortion in an outpatient setting. Investigators will also evaluate factors influencing satisfaction with the procedure. Investigators will compare use of the VR headset with usual care, to usual care only; for a first trimester procedural abortion, usual care includes oral pain medications, local anesthetic medication in the cervix, and verbal reassurance. Participants will be asked to complete a survey before, after, and one week following the procedure to assess pain, anxiety, and overall satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Patients at Planned Parenthood of Western Pennsylvania who have decided to undergo and are eligible for a procedural abortion.
- •18 years old or older
- •<14 weeks gestation on day of abortion
- •Able to comprehend written English
- •Willing to comply with the study protocol
- •Willing and able to provide informed consent
排除标准
- •History of vertigo
- •History of epilepsy
- •Claustrophobia
- •Significant hearing or visual impairments (such as deafness or blindness)
- •Require hearing aids
- •Have an implanted medical device, such as cardiac pacemaker or defibrillator
- •Require misoprostol for cervical preparation
- •Prior unsuccessful attempt at abortion during this pregnancy
研究组 & 干预措施
VR headset
Participants will wear the VR headset during the first trimester procedural abortion, in addition to usual care for pain and anxiety management. The headset will display a meditative nature video throughout the procedure.
干预措施: Usual Care (Other)
Usual care only
Usual care for pain and anxiety management during a first trimester procedural abortion includes oral ibuprofen, intracervical block, and verbal analgesia.
干预措施: Usual Care (Other)
VR headset
Participants will wear the VR headset during the first trimester procedural abortion, in addition to usual care for pain and anxiety management. The headset will display a meditative nature video throughout the procedure.
干预措施: VR headset (Device)
结局指标
主要结局
Pain scores during a first trimester procedural abortion
时间窗: Day of enrollment: immediately preprocedure and 15 minutes postprocedure.
Pain will be measured on a visual analogue scale during and after the procedural abortion via a REDCap survey. The scale is from 0-100, with 0 being "No pain" and 100 being the "Worst pain of my life". The difference in this score (post-procedure minus pre-procedure) is what will be compared between study arms.
Anxiety scores during a first trimester procedural abortion
时间窗: Day of enrollment: immediately preprocedure and 15 minutes postprocedure.
Anxiety will be measured on a visual analogue scale during and after the procedural abortion via a REDCap survey. The scale is from 0-100, with 0 being "No anxiety or fear" and 100 being the "Worst anxiety or fear of my life". The difference in this score (post-procedure minus pre-procedure) is what will be compared between study arms.
次要结局
- Satisfaction with the first trimester procedural abortion(Day of enrollment (immediately postprocedure) and one week after completion of the procedural abortion.)
研究者
Study Investigator
Fellow
University of Pittsburgh