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临床试验/NCT03744845
NCT03744845已完成不适用

The Use of Virtual Reality to Reduce Anxiety and Pain in Perioperative Settings

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年12月10日最近更新:
适应症
干预措施

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
Post-Op Numeric Rating Scale for Pain

研究概览

简要总结

We will investigate whether the use of Virtual Reality (VR) preoperatively and intraoperatively can help treat pain and anxiety, as measured by patient feedback, vital signs trends, and the amounts of anesthetics, pain medications and anxiolytics used during surgical procedures. The VR intervention will be studied during short hand surgeries normally performed using local anesthesia and sedation.

详细描述

Virtual Reality (VR) is a powerful and inexpensive technology that has been effectively used in healthcare settings to treat anxiety and pain, with minimal side effects. In the last two decades, opioid abuse and deaths related to opioids have increased, and opioid naive patients are at increased risk of opioid abuse when opioids are used during their surgical procedures. In addition, anesthetics, anxiolytics and analgesics, namely opioids, have a myriad of side effects that worsen patient experience, and lead to complications and increased costs. There are limited studies on the use of VR in the perioperative setting. Our study is a randomized controlled trial to investigate the use of VR to treat anxiety and pain in perioperative settings. We will recruit 56 patients, 28 in the control group and 28 in the VR group, undergoing short (<2 hrs) hand or upper extremity surgeries under local anesthesia and monitored anesthesia care (MAC). The control group will receive standard anesthetic management and the VR group will be exposed to VR in the preoperative setting and during the surgical procedure, using the clinically validated AppliedVR software. The data collected will included satisfaction questionnaires and pain scores for anxiety/pain pre- and post- procedure, vital signs trends to assess sympathetic response during surgery, and amount of anesthetics used. We hypothesize that the VR group will show decreased anxiety and pain, increased satisfaction, and decreased use of anesthetics during the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •18 years old or older and less or equal to 75 years old.
  • •ASA physical status I-II.
  • •English speaking.
  • •Undergoing elective surgery with local anesthetic with sedation.
  • •Surgical time less than 2 hours.

排除标准

  • •ASA physical status III or above.
  • •Allergy to fentanyl, midazolam or propofol.
  • •History of seizure, migraines.
  • •Chronic Pain Syndrome.
  • •Use of high dose opioids or long acting opioids.
  • •Severe anxiety, on daily anxiolytics.
  • •Psychiatric comorbidities that preclude the use of VR.
  • •Physical disabilities that preclude the use of VR technology in a comfortable manner.
  • •Patient refusal.

研究组 & 干预措施

Control group

No Intervention

Usual anesthetic care.

Virtual Reality Intervention Group

Experimental

Virtual Reality Distraction

干预措施: Virtual Reality Distraction (Other)

结局指标

主要结局

Post-Op Numeric Rating Scale for Pain

时间窗: 1 minute during PACU stay

Self-reported pain intensity post-operation. Each item is scored 0-10 (0 = no pain, 10 = pain as bad as it can be).

Pre-Op Numeric Rating Scale for Pain

时间窗: 1 minute during pre-op period

Self-reported pain intensity pre- and post-operation. Each item is scored 0-10 (0 = no pain, 10 = pain as bad as it can be).

Preoperative Medication Dosage

时间窗: up to 2 hours during pre-op period

The amount of midazolam (milligrams \[mg\]), opioids (mg or micrograms \[mcg\]), propofol (mg), and other sedatives administered to the patient prior to surgery.

Intraoperative Medication Dosage

时间窗: up to 2 hours during surgery

The amount of midazolam (milligrams \[mg\]), opioid (mg or micrograms \[mcg\]), propofol (mg), and other sedatives (mg) administered to the patient during surgery.

Postoperative Medication Dosage

时间窗: approximately 1 hour during PACU stay

The amount of midazolam (milligrams \[mg\]), opioid (mg or micrograms \[mcg\]), propofol (mg), and other sedatives (mg) administered to the patient after surgery.

Pre-Op Numeric Rating Scale for Anxiety

时间窗: 1 minute during pre-op period

Self-reported anxiety intensity pre-operation. Each item is scored 0-10 (0 = no anxiety, 10 = anxiety as bad as it can be).

Post-Op Numeric Rating Scale for Anxiety

时间窗: 1 minute during PACU stay

Self-reported anxiety intensity post-operation. Each item is scored 0-10 (0 = no anxiety, 10 = anxiety as bad as it can be).

次要结局

  • Satisfaction with Anesthesia Survey(5 minutes during PACU stay)
  • Blood Pressure(up to 2 hours during surgery)
  • Heart Rate(up to 2 hours during surgery)
  • Virtual Reality (VR) Survey(5 minutes during PACU stay)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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