A Digital Intervention Protocol to Enhance Recovery After Head and Neck Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean daily opioid use
研究概览
简要总结
Postoperative recovery after head and neck surgery is complex, and often requires utilization of narcotic medications. The aim of this study is to evaluate reduction in pain and use of opioid medications through Virtual Reality (VR) and Fitbit wearable activity devices.
详细描述
Enhanced Recovery After Surgery (ERAS) protocols were introduced as a method to optimize perioperative patient care. Narcotic medications are frequently utilized in postoperative care, but these have risks including sedation or dependence. Non-pharmacologic measures for postoperative pain control may help limit the need for opioids in postoperative pain control.
Early mobilization is also important after surgery, however postoperative mobility is rarely monitored and relies on subjective reports.
The investigators will seek to examine the implementation of an ERAS protocol using VR and Fitbit wearable activity devices on postoperative recovery after head and neck surgery. This is a prospective, 4-arm, randomized controlled trial.
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
- •English speaking
- •18 to 89 years of age.
- •Planned to undergo major head and neck surgery OHSU with an expected length of stay of two days or more.
- •Ability to understand goals of the study and willingness to sign a written informed consent document.
排除标准
- •Planned postoperative admission to the intensive care unit (ICU).
- •Social or psychiatric conditions that may interfere with compliance.
- •Isolation precautions.
- •Reconstruction, incisions, wounds, wound care, or injury that impact the ability to place on the VR headset or wear a Fitbit device around the wrist.
- •History of seizure or epilepsy.
- •History of vertigo or persistent dizziness.
- •Limitations that impair mobility.
- •Use of a walker or wheelchair at baseline.
研究组 & 干预措施
VR Only
Daily VR only. Daily VR use every 3 hours up to 30 minutes at a time.
干预措施: Virtual Reality (Device)
VR and Fitbit
Daily VR use every 3 hours up to 30 minutes at a time and Fitbit daily step goal of 2,000 steps
干预措施: Virtual Reality (Device)
VR and Fitbit
Daily VR use every 3 hours up to 30 minutes at a time and Fitbit daily step goal of 2,000 steps
干预措施: Fitbit (Device)
Fitbit Only
Fitbit daily step goal of 2,000 steps.
干预措施: Fitbit (Device)
Control
Standard of care
结局指标
主要结局
Mean daily opioid use
时间窗: through study completion, an average of 10 days
Mean daily opioid use will be assessed converted into milligram morphine equivalents (MME).
次要结局
- Depression(Before surgery and at study completion, an average of 10 days)
- Pain scores(through study completion, an average of 10 days)
- Length of hospital stay(at study completion, an average of 10 days)
- Anxiety(Before surgery and at study completion, an average of 10 days)
- Patient experience and satisfaction(at study completion, an average of 10 days)
- Sleep Quality(Before surgery and at study completion, an average of 10 days)
- Disposition on discharge(at study completion, an average of 10 days)
研究者
Ryan Li, MD
Principal Investigator
Oregon Health and Science University