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临床试验/NCT04828980
NCT04828980已完成不适用

Impact of Different Virtual Reality Experiences on Anxiety and Pain

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年2月1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
32
试验地点
2
主要终点
Change in patient-reported anxiety

研究概览

简要总结

This trial studies differences between a mindfulness and a gaming virtual reality (VR) experience as a means for preoperative anxiety management and postoperative pain management among patients after head and neck surgery. Investigators will assess differences in anxiety scores, pain scores, physiologic measures, and subjective patient experiences.

详细描述

Optimal postoperative pain control after head and neck surgery is vital for recovery, and non-pharmacologic strategies to improve pain may help reduce narcotic use. Further, preoperative anxiety is common and can impact postoperative pain, analgesic requirements, and recovery. In addition to facilitating with postoperative pain control, VR may have a role in reducing preoperative anxiety. However, it is unclear whether different VR experiences may be more beneficial for different clinical applications.

This study will evaluate if there are differences in preoperative anxiety and postoperative pain when utilizing different VR experiences. Patients undergoing head and neck surgery will be randomly allocated preoperatively to first participate in either a mindfulness or active gaming VR experience, and then postoperatively will crossover and participate in the other experience they did not utilize prior to surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing head and neck surgery
  • Are able to provide informed consent

排除标准

  • Isolation precautions
  • Active eye discharge
  • Active nausea or vomiting
  • History of seizure, epilepsy, or hypersensitivity to flashing light
  • Expected to have wounds or wound care that prevent comfortable and safe use of the VR headset

结局指标

主要结局

Change in patient-reported anxiety

时间窗: baseline, and then 15 minutes later after VR use

Anxiety level will be obtained using a 100mm Visual Analogue Scale (VAS). Preoperative anxiety scores will be obtained prior to VR then immmediately after VR use to assess change in anxiety after each intervention. Score will range from 0 (no anxiety) to 100 (extremely anxious)

Change in patient-reported pain

时间窗: baseline, and then 15 minutes later after VR use

Pain level will be obtained using a 100mm Visual Analogue Scale (VAS). Postoperative pain scores will be obtained prior to VR then immmediately after VR use to assess change in pain level after each intervention. Score will range from 0 (no pain) to 100 (worst pain imaginable)

次要结局

  • Patient experience(1 minute after use of VR)
  • Change in blood pressure(baseline, and then 15 minutes later after VR use)
  • Change in heart rate(baseline, and then 15 minutes later after VR use)

研究者

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

Ryan Li, MD

Assistant Professor of Otolaryngology - Head and Neck Surgery, Division of Head and Neck Surgery, School of Medicine

Oregon Health and Science University

研究点 (2)

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