A Mobile Application for Post-op Analgesic Consumption
2019年10月6日 更新者：Boston University
A Mobile Application to Monitor Patient's Analgesic Consumption After Minor Oral Surgery.
Surgical extraction of third molars is one of the most common outpatient procedures performed by oral surgeons. The prescription of postoperative narcotic and NSAID analgesics is the standard of care practice to relieve symptoms of pain, swelling, and trismus after these procedures. The majority of these patients do not return for follow up unless they experience a problem. There is limited data on whether the patients use the narcotics as directed and what is their practice of disposal of the remaining medications that were not consumed.
In this research the effectiveness of postop analgesic consumption, analgesic disposal practice, pain control, and patient satisfaction will be compared between patients who are randomized to the intervention group who will use a developed mobile application and a control group who will not use the mobile app.
研究概览
详细说明
A pilot randomized clinical trial will be conducted to determine if use of a mobile application improves adherence to narcotic analgesic use and their disposal and patient satisfaction post-surgical extraction of third molars in an outpatient setting.
Eligible consented subjects will be randomized into either the mobile app group or the control group.
Both groups will receive standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions.For the mobile group, the Medable Axon Software developed by Stanford University will be used to customize a mobile application that will be used one week post surgery to monitor postoperative analgesic consumption and disposal practices, pain control, and patient satisfaction, In the control group, case report forms will be used to gather data from the electronic medical records and a telephone survey will be done one week post surgery to obtain data on patient satisfaction.
A total of 20 consecutive eligible patients will be enrolled in this pilot trial..
研究类型
介入性
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02118
- Boston University Medical Campus
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 40年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients between the age of 18-40 years
- Patients who require two mandibular third molars extracted
- Patients with a smartphone
Exclusion Criteria:
- Patients taking any recreational drugs and medications for chronic pain
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Mobile app group
In addition to receiving standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions a customized mobile app will be downloaded to the participant's smartphone to application to monitor postoperative analgesic consumption, disposal and pain control and patient satisfaction for one week after surgery.
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A customized mobile application will be developed and downloaded to subjects; smartphones to monitor postoperative analgesic consumption, and disposal; pain control and patient satisfaction.
The mobile app will provide notifications for medications and select education links on the prescribed analgesics.
Subjects will receive reminders to take medications as directed.
Subjects will be able to monitor and report their pain during the first week after surgery.
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无干预：Control group
The control group will receive the standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions and a case report form will be used to gather data from the medical record and from a post op telephone survey a week after surgery..
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Assessment of quantity of postop analgesic (narcotic and non narcotic) medications used.
大体时间：At the end of 7 days
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Each patient will be given 18-24 tablets the prescription: 1. Acetaminophen with 5mg oxycodone 2. Acetaminophen with 5mg hydrocodone 3. Acetaminophen with 30 mg codine and asked to report each time they take a tablet via the app in the experimental group while the control group will answer the question how many tablets do you have remaining as part of the post survey at the end of 1 week.
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At the end of 7 days
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Assessment of change in Postoperative pain control
大体时间：Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
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The Short Form McGill Pain Questionnaire (SF-MPQ) will be used to assess post-op pain control.
It consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.
Lower scores are associated with less pain..
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Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Satisfaction with the education received regarding the prescribed medications.
大体时间：Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
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Assessment of patient satisfaction using a survey.
For the subjects in the experimental group, they will be asked to complete a emoticon survey on the app which would correspond to the following descriptions: Excellent=4, good=3, average=2, poor=1.The subjects in the control group will be asked the same question as part of the post satisfaction survey without the emoticons as a sentence question.
A lower score indicates low satisfaction.
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Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
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Use of the analgesic and post-op care education links on the mobile app.
大体时间：Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
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Educational links will be available to view as part of the app and usage will be monitored by website traffic.
Higher numbers would indicate greater usage of educational links.
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Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Radhika Chigurupati, DMD, MS、Boston University Medical Campus
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2019年10月1日
初级完成 (预期的)
2020年9月1日
研究完成 (预期的)
2020年9月1日
研究注册日期
首次提交
2017年6月21日
首先提交符合 QC 标准的
2017年6月22日
首次发布 (实际的)
2017年6月23日
研究记录更新
最后更新发布 (实际的)
2019年10月8日
上次提交的符合 QC 标准的更新
2019年10月6日
最后验证
2019年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Mobile app的临床试验
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Klein Buendel, Inc.National Institute on Minority Health and Health Disparities (NIMHD); Pennington Biomedical...完全的
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Environment and Health Group, Inc.Prisma Health完全的
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University of WashingtonNational Institute of Dental and Craniofacial Research (NIDCR)尚未招聘
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VA Office of Research and Development尚未招聘