Trial record 3 of 70 for:    TAKE-IT

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

This study has been terminated.
(Study stopped, recruitment difficult, subject compliance very difficult.)
Sponsor:
Collaborator:
Baeta Corp.
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT02630134
First received: April 2, 2014
Last updated: April 21, 2016
Last verified: April 2016
  Purpose
Study patients are given a hand held device to track pain post surgery.

Condition Intervention
Pain Measurement
Assessment, Pain
Device: These patients receive the Baeta device and take it home

Study Type: Interventional
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.

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Pain score [ Time Frame: 13 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare regression of Baeta Daily Pain scores [ 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 ]

Enrollment: 6
Study Start Date: March 2011
Study Completion Date: October 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baeta
These patients receive the Baeta device and take it home.
Device: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02630134

Locations
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Baeta Corp.
Investigators
Principal Investigator: Michael Haile, MD NYU School of Medicine
  More Information

Publications:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02630134     History of Changes
Other Study ID Numbers: 11-00520 
Study First Received: April 2, 2014
Last Updated: April 21, 2016
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 25, 2016