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临床试验/NCT04464304
NCT04464304已完成不适用

Virtual Reality for Postoperative Pain Management After Head and Neck Surgery: A Randomized Controlled Trial

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年7月11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
30
试验地点
1
主要终点
Change in patient-reported pain scores

研究概览

简要总结

This trial studies an active virtual reality (VR) experience as a means for non-pharmacologic postoperative pain management among patients after head and neck surgery. Investigators will assess differences in pain scores, analgesic use, and subjective patient experiences between patients participating in a VR activity and patients participating in the same activity using a smartphone.

详细描述

Management of postoperative pain after head and neck surgery is complex, and has received increased attention to improve patient recovery and quality of life. Narcotic analgesics are frequently utilized in postoperative pain management, but these have risks including nausea, sedation, constipation, and dependence. Multimodal analgesia can reduce narcotic use and improve recovery, but medical comorbidities may contraindicate the use of certain medications. Non-pharmacologic measures for postoperative pain control may provide novel and cost-effective strategies to confront this complex issue.

Patients undergoing head and neck surgery will be randomly allocated to participate in an immersive experience in VR, or to participate in a similar experience on a two-dimensional screen using a smartphone.

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
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
是

入选标准

  • •Patients who have undergone head and neck surgery with an average pain score of 3 or greater out of 10 during the 24 hours preceding the screening
  • •Are able to provide informed consent
  • •Are not in the intensive care unit (ICU)

排除标准

  • •Symptoms concerning for an active respiratory infection including fever, cough, and shortness of breath or confirmed respiratory infection
  • •Active eye discharge
  • •Active nausea or vomiting
  • •History of seizure, epilepsy, or hypersensitivity to flashing light
  • •History of motion sickness or vertigo
  • •Have wound dressings on the head or neck that prevent comfortable and safe use of the virtual reality headset

研究组 & 干预措施

Virtual Reality

Active Comparator

Patients will be provided with a commercially-available VR device for use up to 15 minutes at bedside.

干预措施: Virtual Reality (Oculus Quest) (Device)

Smartphone

Sham Comparator

Patients will be provided with a commercially-available smartphone device for use up to 15 minutes at bedside.

干预措施: Smartphone (Device)

结局指标

主要结局

Change in patient-reported pain scores

时间窗: Up to 4 hours after intervention use

Pain scores will be obtained using an 11-point Numeric Rating Scale (NRS) prior to each intervention, immediately after the intervention, and then hourly up to 4 hours after the intervention to assess changes in pain scores after each intervention. A score of 0 signifies no pain, and a score of 10 signifies the highest severity of pain.

次要结局

  • Opioid usage(Average 24 hours after intervention use)
  • Patient experience(Up to 4 hours after intervention 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 (1)

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