Device for Monitoring Pain During Intraoperative, Pre/Post Surgical Periods: Comparison With Standard of Care Monitoring

Not Applicable

Terminated

• Conditions: Assessment, Pain; Pain Measurement
• Interventions: Other: These patients receive the Baeta device and take it home

• Registration Number: NCT02630134
• Lead Sponsor: NYU Langone Health

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-06
• Study Completion: 2012-10
• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2015-12-10
• Study First Posted: 2015-12-15
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Baeta	These patients receive the Baeta device and take it home	These patients receive the Baeta device and take it home.

Primary Outcome Measures

Name	Time	Method
Pain score	13 days	VAS score 0-10

Secondary Outcome Measures

Name	Time	Method
Number of cases in which the MHTTM for Pain is superior to standard pain monitoring techniques	13 days	Patients whose use indicated that the MHT TM is a better indicator of pain than standard techniques
Compare regression of Baeta Daily Pain scores	13 days	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	13 days	Comparing the patient's own scores and observers scoring the subject's pain
Number of cases in which the MHTTM for Pain is inferior to standard pain monitoring techniques	13 days	Patients whose use indicated MHT TM was an inferior indicator of pain than standard techniques.

Trial Locations

Locations (1)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States