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临床试验/NCT05570214
NCT05570214撤回不适用

Impact of Virtual Reality on Patient Vital Signs During Urological Bedside Vasectomies

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
Mayo Clinic
入组人数
100
试验地点
2
主要终点
Change in heart rate

研究概览

简要总结

This research is being done to see if virtual reality devices are able to distract patients during Urologic beside vasectomy procedures in the clinic and help improve patient experience and vital signs.

详细描述

Once participants are consented and checked in for the procedure, researchers will obtain the randomization assignment from a REDCap database with a randomization module designed by the study statistician. Participants will be randomized in a 1:1 ratio to either virtual reality or standard of care.

Researchers will collect participant vital signs (heart rate, blood pressure, and SpO2) at check in, laying down on the table, in the midst of the procedure, and after the procedure is complete. After the procedure is completed, all participants will be given two surveys about satisfaction with the experience to complete. Researchers will record any medications the participants takes the day of the procedure. Researchers will then gather demographic data from the participant's chart through Epic (age, height, weight, BMI, race, ethnicity, past medical history, and procedure information). All study data will be stored in a secure REDcap database. Researchers have teamed up with members of the anesthesia department at Mayo Clinic Florida who have performed similar studies utilizing the virtual reality headsets. The department has three virtual reality headsets and know how to operate them.

The participants who are selected to use the virtual reality device will be viewing calming narrated scenarios with relaxing music of walking through a forest, along a beach, through a chinese garden, a winter landscape or taking off in a spaceship or snorkeling through a reef.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Any patient undergoing a vasectomy, transrectal prostate biopsy, cystoscopy, Doppler ultrasound, or Xiaflex.

排除标准

  • Anyone < 18 years of age.

结局指标

主要结局

Change in heart rate

时间窗: Baseline, intra-procedure, post-procedure (approximately 1 hour)

Number of beats per minute

Change in Systolic blood pressure

时间窗: Baseline, intra-procedure, post-procedure (approximately 1 hour)

Measured in millimeters of mercury (mmHg)

Change in diastolic blood pressure

时间窗: Baseline, intra-procedure, post-procedure (approximately 1 hour)

Measured in millimeters of mercury (mmHg)

Change in oxygen saturation levels

时间窗: Baseline, intra-procedure, post-procedure (approximately 1 hour)

Measured by a pulse oximeter reading reported as a percentage

次要结局

  • Patient satisfaction(Post-procedure (approximately 1 hour))

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

David D. Thiel

Principal Investigator

Mayo Clinic

研究点 (2)

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