Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03047915 |
| Other study ID # |
AAAQ3016 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
