Clinical trial NCT02630134: Device for Monitoring Pain During Intraoperative, Pre/Post Surgical Periods: Comparison With Standard of Care Monitoring
Official title: MyHealthTrendsTM Device for Pain for Monitoring Pain During the Intraoperative, Pre and Post Surgical Periods: Comparison With Standard of Care Pain Monitoring.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain Measurement
Assessment, Pain
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Pain score
timeFrame: 13 days
Secondary outcomes:
measure: Compare regression of Baeta Daily Pain scores
timeFrame: 13 days
measure: Correlation of inpatient and outpatient scores with chart indications of pain, VAS scores and observer scoring of pain behavior
timeFrame: 13 days
measure: Number of cases in which the MHTTM for Pain is superior to standard pain monitoring techniques
timeFrame: 13 days
measure: Number of cases in which the MHTTM for Pain is inferior to standard pain monitoring techniques
timeFrame: 13 days
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Michael Haile, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1111/j.1526-4637.2007.00374.x.