A Smart Device Application for Acute Pain Service in Patients Undergoing Major Surgery: A Prospective Observational Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Patients' adherence rate to Smart APS
研究概览
简要总结
The app will be installed on the patient's smartphone before surgery. Patients will receive reminders to record their pain intensity and opioid-related side effects at the pre-determined time points until at least 2 days after surgery. The patient's compliance with the reminders will be assessed. On the second postoperative day, their satisfaction with pain control and app usage will be evaluated. Patients can also provide feedback on any issues they have encountered with the app during the study period.
详细描述
Following admission, the application will be installed on the enrolled patient's smartphone prior to surgery, and the patient will be instructed on the content of the program and how to use it. Educational videos within the app about postoperative pain control will be introduced to the patient at this time. At the pre-determined time points, until at least 2 days post-operatively, the patient will be reminded of the assessment via an alarm function and will enter post-operative pain intensity using an 11-point numeric rating scale or verbal rating scale and the presence of opioid-related side effects into the application. If a patient responds to the alarm 2 or more times per day, they will be considered to be compliant. Postoperative opioid consumption using patient-controlled analgesia and the amount of rescue analgesics will be assessed. Patients will be assessed with a survey on postoperative day 2 for overall satisfaction with pain control and usage of the application. Patients will also be able to provide feedback via the application or research staff on any errors or inconveniences they may have experienced while using the application throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
As this is an observational study to assess feasibility, the participants, care providers, researchers, and outcome assessors cannot be masked by the nature of the design.
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 19 to 70 years who are scheduled for regular major surgery
- •American Society of Anesthesiologists (ASA) physical status classification I or II
- •Patients who are using a smartphone and are not expected to have any restrictions on application use
排除标准
- •Unable to communicate
- •Patients under the age of 19 and over the age of 70
- •Patients who, in the opinion of the investigator or study staff, are not appropriate for this study
结局指标
主要结局
Patients' adherence rate to Smart APS
时间窗: Postoperative day 1 and 2
Proportion of patients who successfully used the smart APS among all patients.. Through Smart APS, a self-assessment is conducted three times a day, and it is assumed that the application has been used successfully if the patient completes an evaluation of pain intensity and opioid analgesic side effects at least twice on the first and second days after surgery.
次要结局
- Patient satisfaction with pain management(Postoperative day 2)
- Patient satisfaction with application usage(Postoperative day 2)
研究者
Hojin Lee, MD
Associate professor
Seoul National University Hospital