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OpenTrials
Completed

NCT Number: NCT03047915

Music in the Emergency Department (ED)

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).

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music

Other

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

Primary outcomes

  1. Mean Change in STAI Score

    Time frame: Baseline and 1 hour post-intervention

    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.

Secondary outcomes

  1. Mean Change in Heart Rate (HR)

    Time frame: Baseline and 1 hour post-intervention

    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.

  2. Mean Change in Blood Pressure (BP)

    Time frame: Baseline and 1 hour post-intervention

    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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2020
First posted
Feb 9, 2017
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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