Music in the Emergency Department (ED)

NCT03047915 | Completed

• 1 other identifier: AAAQ3016
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety

Keywords

Anxiety; Music intervention; Emergency department (ED)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mean Change in Heart Rate (HR)

  Baseline and 1 hour post-intervention

• Mean Change in Blood Pressure (BP)

  Baseline and 1 hour post-intervention

Study Arms (2)

Control Group

NO INTERVENTION

All subjects enrolled will respond to questions assessing anxiety using the State Trait Anxiety Inventory (STAI), and pain using a 1-10 numerical score, and will have blood pressure and heart rate taken. Subjects randomized to the control group will continue the ED visit as usual.

Music Group

EXPERIMENTAL

All subjects enrolled will respond to questions assessing anxiety using the State Trait Anxiety Inventory (STAI), and pain using a 1-10 numerical score, and will have blood pressure and heart rate taken. Subjects who are randomized to receive a music-listening intervention will listen to a choice of music for 30 to 60 minutes on a loaned iPad with disposable headphones. An hour after enrollment, participants will be asked the same questions assessing anxiety and pain, and will also have blood pressure and heart rate taken again.

Other: Music

Interventions

Music OTHER

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

Music Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Emergencies

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ellen D. Sano, DO

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: February 9, 2017
• Study Start: June 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 30, 2020
• Last Updated: June 11, 2021

Record last verified: 2021-06

Locations

US (1)