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CompletedNCT03384576Updated Jun 14, 2019

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

An interventional study of Music intervention and No music in Anxiety, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-14.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
350
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anxiety

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Keywords

  • Music
  • Emergency
  • caregivers
03

In context

Anxiety Disorders Unverified

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's enrollment of 350 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Non-english speaking caregivers
  • Hearing impaired caregivers
  • Caregivers accompanying a patient with an acuity level less than 4
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
350 participants (actual)

Study arms

  • Experimental
    Music intervention

    Participants listen to music in the waiting room

    Other: Music intervention

  • Active comparator
    No music

    Participants will not have music in the waiting room

    Other: No music

Interventions

  • OtherMusic intervention

    Classical music to be played in the Emergency waiting room

  • OtherNo music

    No music played in emergency waiting room

06

What researchers measure

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

    Time frame: up to 10 hours

Secondary outcomes

  1. Perceived waiting time

    Participants will be asked about perceived waiting time

    Time frame: up to 10 hours

07

Study locations

1 site
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Jun 2019, 10 months.

Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 10 months is below that.

Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2017
First posted
Dec 27, 2017
StartActual
Jul 24, 2018
Primary completionActual
Jun 1, 2019
CompletionActual
Jun 1, 2019
Last update
Jun 14, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03384576
Responsible party
Jennifer Smedley (Principal Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
Dec 27, 2017
Start date
Jul 24, 2018
Primary completion
Jun 1, 2019
Completion
Jun 1, 2019
Last update
Jun 14, 2019

Study contacts

Jennifer M Smedley, DO
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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