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临床试验/NCT02630134
NCT02630134终止不适用

MyHealthTrendsTM Device for Pain for Monitoring Pain During the Intraoperative, Pre and Post Surgical Periods: Comparison With Standard of Care Pain Monitoring.

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2011年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
1
主要终点
Pain score

研究概览

简要总结

Study patients are given a hand held device to track pain post surgery.

详细描述

The MyHealthTrends™ for Pain Tracking System is a revolutionary consumer-oriented pain monitoring system enabling individuals to record the pain participants experience with the click of a button. Developed by a doctor for the ultimate use within hospital and outpatient settings, MyHealthTrends™ for Pain enables anyone afflicted with pain to easily record their sensations - helping to acquire faster and superior diagnoses and treatment. Among the benefits of the MyHealthTrends™ for Pain Tracking System are that it enables patients to: i] easily record the pain experienced in real-time - capturing accurate information; ii] shift from memory-based descriptions of experienced pain to data-driven, time based recordings; iii] provide objective evidence of the pain experienced.

It is extremely portable and convenient to carry, approximately the size of a modern automobile key. Since it can be uploaded to a confidential internet site by way of a computer, which site is then accessible to the physician, it provides various additional benefits. These include allowing the physician to: i] identify breakthrough pain episodes; ii] determine analgesic requirements with a real time detailed pain record; iii] prescribe the appropriate regimen with confidence; and iv] monitor pain levels experienced by the patient, free of distortion caused by memory biases and lapses.

The purpose of this study is to provide detailed and quantitative comparisons of the device's performance during a demanding clinical inpatient surgery episode, where standard pain monitoring and therapy are in use. The device is extremely easy to use involving merely the press of a button; and so it would not distract from any standard communication of pain symptoms, which the subject were inclined to convey. The device stores all information (time and date stamped) for downloading through a USB plug to a computer when the study is completed and the patient discharged.

Specifically, investigators will identify 40 post thoracotomy patients expected to receive a PCA or epidural for post op pain control at Tisch hospital. Patients will be given the device and asked to record their pain in the immediate post op period until discharge. The information obtained from the electronic diary will be correlated with pain records based on nurse's chart, administration of pain medication, VAS pain questionnaire instruments given daily to each patient, and call button utilization.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • 18 or older
  • post thoracotomy with a consult placed to the acute pain service on post-op day 0 for management of a PCA or epidural
  • mental status permits patient to reliably press a button to record pain or administer medications
  • must be hemodynamically stable
  • must be able to physically use the MyHealth trends diary (press a button)
  • supplies written informed consent.

排除标准

  • less than 18 years of age
  • has any underlying or current medical condition, which, in the opinion of the Investigator, would interfere with the use of the MyHealth trends device (e.g. severe psychosis, quadrapalegic, etc.)
  • Subject necessitates ICU care

研究组 & 干预措施

Baeta

Experimental

These patients receive the Baeta device and take it home.

干预措施: These patients receive the Baeta device and take it home (Other)

结局指标

主要结局

Pain score

时间窗: 13 days

VAS score 0-10

次要结局

  • Compare regression of Baeta Daily Pain scores(13 days)
  • Number of cases in which the MHTTM for Pain is superior to standard pain monitoring techniques(13 days)
  • Correlation of inpatient and outpatient scores with chart indications of pain, VAS scores and observer scoring of pain behavior(13 days)
  • Number of cases in which the MHTTM for Pain is inferior to standard pain monitoring techniques(13 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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