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

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

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

Study Overview

• Status: Terminated
• Conditions: Pain Measurement; Assessment, Pain
• Intervention / Treatment: Other: These patients receive the Baeta device and take it home

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baeta; These patients receive the Baeta device and take it home.	Other: These patients receive the Baeta device and take it home

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	VAS score 0-10	13 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare regression of Baeta Daily Pain scores	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).	13 days
Correlation of inpatient and outpatient scores with chart indications of pain, VAS scores and observer scoring of pain behavior	Comparing the patient's own scores and observers scoring the subject's pain	13 days
Number of cases in which the MHTTM for Pain is superior to standard pain monitoring techniques	Patients whose use indicated that the MHT TM is a better indicator of pain than standard techniques	13 days
Number of cases in which the MHTTM for Pain is inferior to standard pain monitoring techniques	Patients whose use indicated MHT TM was an inferior indicator of pain than standard techniques.	13 days

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Michael Haile, MD, NYU School of Medicine

Publications and helpful links

General Publications

• Gaertner J, Elsner F, Pollmann-Dahmen K, Radbruch L, Sabatowski R. Electronic pain diary: a randomized crossover study. J Pain Symptom Manage. 2004 Sep;28(3):259-67. doi: 10.1016/j.jpainsymman.2003.12.017. Erratum In: J Pain Symptom Manage. 2004 Dec;28(6):626.
• Marceau LD, Link C, Jamison RN, Carolan S. Electronic diaries as a tool to improve pain management: is there any evidence? Pain Med. 2007 Oct;8 Suppl 3:S101-9. doi: 10.1111/j.1526-4637.2007.00374.x.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: April 2, 2014
• First Submitted That Met QC Criteria: December 10, 2015
• First Posted (Estimate): December 15, 2015

Study Record Updates

• Last Update Posted (Actual): July 18, 2017
• Last Update Submitted That Met QC Criteria: July 13, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 11-00520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No