Music in the Emergency Department (ED)

Anxiety Clinical Trial

Official title:

The Effects of a Music Intervention on Older Adults in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047915
• Other study ID #: AAAQ3016
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: October 30, 2020

Study information

• Verified date: June 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: October 30, 2020
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Emergencies

Intervention

Other:
• Music
The intervention consists of listening to a choice of music for 30 to 60 minutes on a loaned iPad with disposable headphones.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in STAI Score	The STAI is scored from least/no anxiety (20 points) to severe anxiety (80 points). The mean change in STAI scores from before the intervention to after the intervention will be calculated by subtracting the first score from second score.	Baseline and 1 hour post-intervention
Secondary	Mean Change in Heart Rate (HR)	The HR of patients will be recorded before and immediately after the intervention (for control subjects, 1 hour after enrollment). Difference in HR will be calculated by comparing pre to post and mean change calculated for each group.	Baseline and 1 hour post-intervention
Secondary	Mean Change in Blood Pressure (BP)	The BPs of subjects will be collected before and after the intervention (for control group, 1 hour after enrollment). Change in BP will be calculated per patient and the mean change calculated for each group.	Baseline and 1 hour post-intervention