Device for Monitoring Pain During Intraoperative, Pre/Post Surgical Periods: Comparison With Standard of Care Monitoring
Device: These patients receive the Baeta device and take it home
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||MyHealthTrendsTM Device for Pain for Monitoring Pain During the Intraoperative, Pre and Post Surgical Periods: Comparison With Standard of Care Pain Monitoring.|
- Pain score [ Time Frame: 13 days ] [ Designated as safety issue: No ]
- Compare regression of Baeta Daily Pain scores as a function of VAS [ Time Frame: 13 days ] [ Designated as safety issue: No ]
Interpatient comparison of regression of Baeta Daily Pain Score as a function of VAS score
- Correlation of inpatient and outpatient scores with chart indications of pain, VAS scores and observer scoring of pain behavior (none, mild, moderate, severe).
- Correlation of inpatient and outpatient scores with chart indications of pain, VAS scores and observer scoring of pain behavior [ Time Frame: 13 days ] [ Designated as safety issue: No ]
- Number of cases in which the MHTTM for Pain is superior to standard pain monitoring techniques [ Time Frame: 13 days ] [ Designated as safety issue: No ]
- Number of cases in which the MHTTM for Pain is inferior to standard pain monitoring techniques [ Time Frame: 13 days ] [ Designated as safety issue: No ]
|Study Start Date:||March 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
These patients receive the Baeta device and take it home.
|Device: These patients receive the Baeta device and take it home|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02630134
|United States, New York|
|NYU Langone Medical Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Michael Haile, MD||NYU School of Medicine|