Measuring Changes in Acute Pain in the Emergency Department Using Patient Reported Scales

October 24, 2013 updated by: Hennepin Healthcare Research Institute
Patient reported pain, stress, and anxiety measures have been found to be inter-related, but it is not known if they are all associated with receiving opiate medications. The objective of this study is to determine if patients' degree of reported pain, stress, or anxiety is associated with receiving opiate pain medications in the emergency department or at discharge. Alert patients at least 18 years of age and who report pain greater than 3/10 are eligible to participate in the study. Consenting patients complete Visual Analog Scales describing their perceived pain, stress, and anxiety from enrollment until discharge. Demographic data and administration of pain medication is also recorded. Visual Analog Scale scores among patients who received an opioid pain medicine in the emergency department and at discharge will be compared to those who did not.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3630

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to the emergency department at an urban county hospital.

Description

Inclusion Criteria:

  • Reported pain greater than or equal to 3 out of 10

Exclusion Criteria:

  • Less than 18 years of age
  • Decreased level of consciousness
  • Inability to answer questions
  • Prisoner

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
In pain
Patients who report pain greater than or equal to 3 out of 10 are eligible for this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Described Stress
Time Frame: Immediately upon enrollment, every 30 minutes after until hospital discharge, and upon discharge, for up to 24 hours.
Patients describe stress by completion of 100 mm Visual Analog Scale, bordered by the words "no stress" and "most stress possible".
Immediately upon enrollment, every 30 minutes after until hospital discharge, and upon discharge, for up to 24 hours.
Change in Patient described anxiety.
Time Frame: Immediately upon study enrollment, every 30 minutes post-enrollment, and upon hospital discharge, for up to 24 hours.
Patients describe anxiety by completing 100mm Visual Analog Scale, bordered by the words "no anxiety" and "most anxiety possible".
Immediately upon study enrollment, every 30 minutes post-enrollment, and upon hospital discharge, for up to 24 hours.
Change in patient described satisfaction with ongoing treatment.
Time Frame: Immeditately upon enrollment, every 30 minutes post-enrollment, and upon hospital discharge, up to 24 hours.
Patients describe satisfaction with ongoing treatment by completion of 100mm Visual Analog Scale, bordered by the words "not satisfied at all" and "completely satisfied".
Immeditately upon enrollment, every 30 minutes post-enrollment, and upon hospital discharge, up to 24 hours.
Change in patient described pain.
Time Frame: Immediately upon enrollment, every 30 minutes post-enrollment, and upon discharge, for up to 24 hours.
Patients describe pain by completing a 100mm Visual Analog Scale, bordered by the words "no pain" and "worst pain possible".
Immediately upon enrollment, every 30 minutes post-enrollment, and upon discharge, for up to 24 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 31, 2012

First Submitted That Met QC Criteria

November 5, 2012

First Posted (Estimate)

November 7, 2012

Study Record Updates

Last Update Posted (Estimate)

October 25, 2013

Last Update Submitted That Met QC Criteria

October 24, 2013

Last Verified

October 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe