VR 4 BR: Effects of Virtual Reality on Women Undergoing Mastectomy and Breast Reconstruction, A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Morphine Milligram Equivalents
研究概览
简要总结
This is a pilot study of virtual reality (VR) non-opioid management for women undergoing mastectomy and implant-based reconstruction. Study participants will receive specialized VR interventions, administered via VR headsets, to manage pain.
详细描述
The primary objective of this study is to estimate the effect of utilizing VR on reducing opioid use in study participants undergoing mastectomy with implant-based reconstruction compared to the control group. Investigators will follow patients throughout the course of their hospitalization and monitor outcomes including pain levels, medication requests, and satisfaction.
Eligible participants will receive a VR headset and instructed to use the VR every time they feel pain and before asking for a pain medication. They can take pain medications, if they choose to do so. At their post-op visit, study participants will be interviewed and asked questions regarding their experience with VR.
Pain level and medication use will be compared with similar individuals who undergo the same procedure but are not provided with a VR headset.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Age ≥ 18 years
- •Women who plan to undergo mastectomy and implant-based reconstruction
- •Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- •Able to read and comprehend English
排除标准
- •Current diagnosis of epilepsy, dementia, or other neurologic disease that may prevent use of VR headset and software
- •Sensitivity to flashing light
- •Diagnosis of motion sickness
- •Pregnancy or a medical condition where the study participant is prone to frequent nausea or dizziness
- •Current or recent (less than 6 months) use of opioids
- •Individuals with psychiatric disorders, including those with delirium or other disorders that may involve hallucinations or psychosis
结局指标
主要结局
Morphine Milligram Equivalents
时间窗: During hospitalization until discharge, approximately 2 days
Opioid usage is defined as mean total milligrams of morphine equivalent (MME), calculated by first multiplying the quantity of each prescribed medication by the strength of that medication (milligrams of given opioid per unit dispensed), and then multiplying this quantity-strength product by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription.
次要结局
- Mean Difference in Pain(From operation to discharge, approximately 2 days)
- Mean Difference in Length of Stay(During hospitalization until discharge, approximately 2 days)
研究者
Alice Chung
Assistant Professor of Surgery
Cedars-Sinai Medical Center