Clinical trial NCT03047915: Music in the Emergency Department (ED)
Official title: The Effects of a Music Intervention on Older Adults in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Music intervention
Emergency department (ED)
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 169
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This will be a randomized controlled study evaluating the effect of a music-listening intervention compared to standard care (control) during patient visit to the emergency department (ED). Randomization will be done with consecutive sealed envelopes.

Data collection will be prospective with administration of the State Trait Anxiety Inventory and collection of physiologic parameters (pain level, heart rate, blood pressure). Retrospective data will also be collected for covariate analysis (age, race/ethnicity, emergency severity index (ESI), pain medications administered during the ED visit, pain scores throughout ED visit, chief complaint, and ED discharge diagnosis).

Detailed description: A visit to the emergency department (ED) is anxiety provoking for patients by nature. Contributing factors may include the sudden timing of the visit, a noisy environment, and waiting in anticipation of a serious diagnosis or bad news. Studies suggest that nearly 75% of adult ED patients may experience mild to severe anxiety in relation to the ED visit, but not directly related to their chief complaint. Anxiety can have deleterious effects on a patient in the clinical setting. Patients may report excessive pain complaints and manifest the typical signs and symptoms of anxiety (e.g. anorexia, dry mouth, nausea, chest pain), which can complicate diagnosis. Patient anxiety can also impose barriers to communication with ED staff, hindering successful delivery of important medical information. A visit to the ED may be particularly distressing for older adults (age 65+), for they are more likely than younger adults to have a greater ED length of stay before discharge home, receive more diagnostic tests and venipuncture for intravenous (IV) access, and have poorer pain care. Music listening as an anxiolytic has been shown to be effective across a variety of clinical settings, however there is a relative paucity of published data on the use of music listening for adult patients in the ED. No published studies, to the investigators' knowledge, have evaluated the effect of music listening on older adults in the ED.

Eligibility criteria: Inclusion Criteria:

* Present to the ED
* Aged 65 or over
* Speak English or Spanish

Exclusion Criteria:

* Individuals who are deaf
* Prisoners
* Individuals who cannot give informed consent

Primary outcomes:
measure: Mean Change in STAI Score
timeFrame: Baseline and 1 hour post-intervention
Secondary outcomes:
measure: Mean Change in Heart Rate (HR)
timeFrame: Baseline and 1 hour post-intervention
measure: Mean Change in Blood Pressure (BP)
timeFrame: Baseline and 1 hour post-intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Ellen D. Sano, DO
role: PRINCIPAL_INVESTIGATOR
References: