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临床试验/NCT03914937
NCT03914937已完成不适用

Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction

The Guthrie Clinic1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Blood pressure

研究概览

简要总结

The study is looking at whether wearing a virtual reality device will help reduce pain and anxiety during minor procedures

详细描述

Patients who are undergoing minor plastic surgery procedures will be assigned to either wear a virtual reality device or to listen to music of their choice. Patients will still get the standard lidocaine/novocaine numbing agent. Patients will be asked questions about their anxiety level and pain level. Heart rate and blood pressure will be monitored as measures of anxiety and pain.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for minor elective plastic surgery procedure
  • Patients without cognitive, visual or hearing impairments

排除标准

  • Patients with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay)
  • Lesions that involve portions of the head or face that will prohibit the use of VR goggles
  • Severe vertigo
  • Patients with nausea, vomiting, dementia, motion sickness, stroke, seizure and epilepsy and those placed in isolation (MRSA, VRE) were excluded.
  • Patients who are pregnant
  • Hearing or visually impaired
  • Patients <18 years old

结局指标

主要结局

Blood pressure

时间窗: 1 hour

Systolic and diastolic blood pressures (mmHg) at the half way point of the procedure as well as 1 minute after completion of the procedure. Blood pressure will be measured as a surrogate measure for objective pain. Blood pressures will be averaged for each cohort. The data will be collected by Dynamap automated Blood pressure monitor.

Subjective Pain

时间窗: 1 hour

Subjective pain measured using the 11-point Numeric Rating Scale (NRS), which is widely employed and is a validated measure of pain (17) at the half way point and 1 minute after the procedure.The scale name is Pain Numeric Rating Scale (NRS) it is a validated scale for graphically measuring pain. The scale range is 0-10 (11 point scale). 0 is no pain. 10 is intolerable pain. The values on this scale will be averaged for each cohort.

Heart rate

时间窗: 1 hour

Heart rate at the half way point of the procedure as well as 1 minute after completion of the procedure will be measured in beats per minute using pulse oximetry. Heart rate will be measured as a surrogate measure for objective pain. Heart rates will be averaged for each cohort.

次要结局

  • Patient Satisfaction(1 hour)
  • Anxiety(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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