Recruiting

Observational Study

Sponsor:

Leslie Zun, MD

Code:

NCT02713100

Conditions

Psychiatric Issue

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

level of agitation

Study Details

Brief 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

Study ID

NCT02713100

Start date

Oct, 2014

Status verified date

Mar, 2017

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Patients can be enrolled in the study only if they meet all of the following criteria:

1. Presenting with a psychiatric complaint.
2. Male or female patients at least 18 years of age.
3. Patients must be emergency department patients during the study.
4. Each patient, or a patient's legal representative (as allowed by local law), must understand the nature of the study and must agree to study enrollment.
5. English speaking.
6. Consenting

Exclusion Criteria:

1. Unstable patients
2. Patients who have delirium or dementia will be excluded because of its complicated medical rather than psychiatric etiologies.
3. Prisoners
4. Pediatric patients

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

level of agitation

psychological pain

Primary outcome measure

  • Brief Agitation Measure [ Time Frame: 5 MINUTES ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospital

Recruiting

Chicago, Illinois, United States, 60608

Contacts

More Information

Sponsor

Leslie Zun, MD

Last update posted

Mar 22, 2017

Last verified

Mar, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Leslie Zun, MD on 2017-03-22.