NCT03384576

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 27, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

July 24, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 14, 2019

Status Verified

June 1, 2019

Enrollment Period

10 months

First QC Date

December 8, 2017

Last Update Submit

June 12, 2019

Conditions

Anxiety

Keywords

MusicEmergencycaregivers

Outcome Measures

Primary Outcomes (1)

  • reduction in anxiety score

    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 Outcomes (1)

  • Perceived waiting time

    up to 10 hours

Study Arms (2)

Music intervention

EXPERIMENTAL

Participants listen to music in the waiting room

Other: Music intervention

No music

ACTIVE COMPARATOR

Participants will not have music in the waiting room

Other: No music

Interventions

Music interventionOTHER

Classical music to be played in the Emergency waiting room

Music intervention
No musicOTHER

No music played in emergency waiting room

No music

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Anxiety DisordersEmergencies

Condition Hierarchy (Ancestors)

Mental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer M Smedley, DO

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 8, 2017

First Posted

December 27, 2017

Study Start

July 24, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

June 14, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)