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

Pain Measurement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02630134
• Other study ID #: 11-00520
• Status: Terminated
• Phase: N/A
• First received: April 2, 2014
• Last updated: July 13, 2017
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: July 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Assessment, Pain
• Pain Measurement

Intervention

Other:
• These patients receive the Baeta device and take it home

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Erratum in: J Pain Symptom Manage. 2004 Dec;28(6):626. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	VAS score 0-10	13 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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