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Self Reported Level of Agitation of Patients Presenting to an Emergency Department

NCT02713100 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2017-03-22

No results posted yet for this study

Summary

In recent years, there has been an emphasis on assessing patient's pain on presentation to emergency departments. The Joint Commission mandates that all patients who present with pain must have a pain assessment performed and addressed early in their care. Most emergency departments are using a self-reported assessment of pain using a 1-10 scale of pain. This self-reported level of pain is used to determining appropriate treatment. The Joint Commission has only dealt with somatic pain and has not addressed psychological related pain.

Many authors have written on psychological pain. It is described as introspective experience of negative emotions such as anger, despair, fear, grief, shame, guilt, hopelessness, loneliness and loss. The assessment of psychological pain has been used to describe patients with depression and suicidal thoughts and behaviors.

Study Significance The significance of this study is to determine if patients can communicate the level of psychological pain using the level of agitation as a surrogate marker. Studies have demonstrated that the staff's assessment of a patient's level of agitation is not based on an agitation scale nor uses any patient self-assessment of their level of agitation. If a self-assessment of a patient's level of agitation can be determined early in their care in the emergency setting, a proactive approach to treatment can occur. Proactive agitation treatment has the potential of reducing a patient's agitation and increasing their level of comfort. This early intervention can reduce the progression of agitation and the risk of injury to patients, families and staff.

Hypothesis The study null hypothesis is that the self-rated agitation scale will not have a significant level of correlation with the other measures of agitation (Brief Agitation Measure, Positive And Negative Syndrome Scale and Agitation Calmness Evaluation Scale). The secondary null hypothesis is that there is no difference between the level of agitation and the level of psychological pain, assessed with the Psychological Pain Assessment.

Conditions

  • Psychiatric Issue

Interventions

BEHAVIORAL

level of agitation

psychological pain

Sponsors & Collaborators

  • Teva Pharma

    collaborator INDUSTRY

  • Leslie Zun, MD

    lead OTHER

Principal Investigators

  • Les Zun, MD · MOUNT SINAI HOSPITAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02713100 on ClinicalTrials.gov