The Effect of Music in the Pediatric Emergency Department Waiting Room on Caregiver Anxiety

June 12, 2019 updated by: Jennifer Smedley, University of Alabama at Birmingham
The purpose of this research study is to examine the effects of playing classical music in the waiting room on caregiver anxiety. People who enter the study will be asked a few identifier questions including age and relation to patient and then will be asked fill out a survey regarding anxiety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study investigators will initially screen for participants based on the patient's acuity level. If the patient meets the low acuity requirement and if they have a wait time greater than 20 minutes then the caregiver will be approached to obtain informed consent once they have been placed in a room. If they choose to be included in the study, the patient's medical record number will be recorded, a personal identification number will be assigned, and the patient's information will be entered into the personal identification number key and into our research database. A questionnaire asking participants age and relation to patient and the state-trait anxiety inventory will be administered to the caregiver. An additional question of perceived wait time will also be asked.

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult caregivers; age >18 year, accompanying a pediatric patient with acuity level ≥ 4
  • Patient must have been in waiting area for at least 20 minutes

Exclusion Criteria:

  • Non-english speaking caregivers
  • Hearing impaired caregivers
  • Caregivers accompanying a patient with an acuity level less than 4

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Music intervention
Participants listen to music in the waiting room
Other: Music intervention
Classical music to be played in the Emergency waiting room
ACTIVE_COMPARATOR: No music
Participants will not have music in the waiting room
Other: No music
No music played in emergency waiting room

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction in anxiety score
Time Frame: up to 10 hours
Participants will be administered with the State Trait Anxiety Inventory questionnaire , Scores range from 20-80 with higher score indicates greater anxiety
up to 10 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived waiting time
Time Frame: up to 10 hours
Participants will be asked about perceived waiting time
up to 10 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Jennifer M Smedley, DO, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 24, 2018

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

December 8, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (ACTUAL)

December 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2019

Last Update Submitted That Met QC Criteria

June 12, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300001035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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