Study Stopped
Study stopped, recruitment difficult, subject compliance very difficult.
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.
1 other identifier
interventional
6
1 country
1
Brief Summary
Study patients are given a hand held device to track pain post surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 2, 2014
CompletedFirst Posted
Study publicly available on registry
December 15, 2015
CompletedJuly 18, 2017
July 1, 2017
3 months
April 2, 2014
July 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pain score
VAS score 0-10
13 days
Secondary Outcomes (4)
Compare regression of Baeta Daily Pain scores
13 days
Correlation of inpatient and outpatient scores with chart indications of pain, VAS scores and observer scoring of pain behavior
13 days
Number of cases in which the MHTTM for Pain is superior to standard pain monitoring techniques
13 days
Number of cases in which the MHTTM for Pain is inferior to standard pain monitoring techniques
13 days
Study Arms (1)
Baeta
EXPERIMENTALThese patients receive the Baeta device and take it home.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Medical Center
New York, New York, 10016, United States
Related 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. doi: 10.1016/j.jpainsymman.2003.12.017.
PMID: 15336338BACKGROUNDMarceau 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.
PMID: 17877520BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Haile, MD
NYU School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2014
First Posted
December 15, 2015
Study Start
March 1, 2011
Primary Completion
June 1, 2011
Study Completion
October 1, 2012
Last Updated
July 18, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share