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临床试验/NCT03851042
NCT03851042Unknown不适用

Use of Virtual Reality for Postoperative Pain After Laparoscopic Hysterectomy

University of Arizona2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
PACU satisfaction survey

研究概览

简要总结

Patients will be randomized to either receive virtual reality headsets in the post anesthesia recovery unit (PACU) as an adjunct therapy or undergo routine postoperative management. Pain scores will be recorded at standardized intervals in the PACU. The patient will be asked to complete a survey at their two week post op visit assessing their satisfaction with their post op recovery.

The purpose of this study is to determine whether a virtual reality relaxation program used in the immediate postoperative period after laparoscopic hysterectomy will decrease pain scores and reduce both oral and intravenous opioid consumption.

详细描述

According to the CDC, 115 Americans die every day due to opioid overdose. Prescription opioid related overdose deaths accounted for 40% of all opioid deaths in the US in 2016. In surgery, opioids are an effective tool in reducing pain in the postoperative state. However, this may lead to dependence if pain control is poorly managed. A study examining analgesic use after low risk surgery found that patients requiring a second prescription for opioids within 7 days of their surgery were 44% more likely to become long-term opioid users one year after their surgery.

n order to combat this issue, the concept of multi-modal analgesia has been promoted to reduce the use of opioids for postoperative pain. This modality includes medications (e.g. NSAIDS), regional anesthesia, and adjunct therapies such as meditation and acupuncture.

Virtual reality (VR) is an emerging technology in which a person is immersed in an environment through visual and audio cues that effect the senses. These effects can lead to all types of reactions based on the content and as such, virtual reality is used as a platform for, amongst other things, entertainment, education and patient care.

In health care, virtual reality has been used to desensitize patients with various phobias, provide surgical training and as an effective tool for pain control. At this time, there are no studies demonstrating the use of virtual reality for pain control after gynecologic surgery.

This is a feasibility study to asses if VR can be used for postoperative pain control and whether a VR relaxation program used in the immediate post operative period after laparoscopic hysterectomy will decrease pain scores and reduce both oral and intravenous opioid consumption. If this study is feasible the investigators would then be able to perform a larger study, which could show if VR does or does not reduce postoperative pain. Possible benefits from this study include improved pain control requiring less narcotic medications during the time spent in the PACU after laparoscopic hysterectomy for benign indication. It could also provide improvement of anxiety associated with the postoperative period. This intervention could be a benefit for all women who desire to use non-pharmacologic measures for pain control during the immediate postoperative period. Alternatively, the patient can proceed without the intervention if desired. There are many other pain control methods that the patient can still use during the study. Nothing will be withheld from the patient due to the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Upon enrollment, the patient will be randomized using the REDcap randomization tool.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Any patient undergoing laparoscopic hysterectomy
  • Benign indications
  • Dr. Jamal Mourad or Dr. Nichole Mahnert will be performing hysterectomy

排除标准

  • Non-English speakers
  • History of chronic opioid use
  • History of epilepsy
  • History of claustrophobia
  • Have received a prescription or taken opioids within 2 weeks for their scheduled surgery

结局指标

主要结局

PACU satisfaction survey

时间窗: 2 weeks post operative visit

Survey asking questions regarding their satisfaction with use of VR. A 7-point Likert scale will be used to assess satisfaction with VR modality. 1- very dissatisfied, 2-disatisfied, 3-neutral, 4-satisfied, 5-very satisfied

Meds used at home post op for pain control

时间窗: 2 week postoperative op visit

Patients will be asked about specific medications used at home for post op pain control. We will specifically determine the morphine equivalents used for opioids.

Visual Analogue scale for pain

时间窗: Immediately following surgery

This is a 1-10 scale that will be asked to patients to assess pain level while in the postoperative care unit, 0=no pain on a graduated scale to 10=worst pain.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nichole Mahnert

Nichole Mahnert, MD, Associate Professor Dept of Obstetrics and Gynecology, MIS Fellowship Co-Director, Endometriosis and Chronic Pelvic Pain Clinic, UofA, BUMCP

University of Arizona

研究点 (2)

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