Back to resultsThe Effect of Music in the Pediatric Emergency Department Waiting Room on Caregiver Anxiety
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music intervention
No music
Sponsored by
About this trial
This is an interventional other trial for Anxiety focused on measuring Music, Emergency, caregivers
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Music intervention
No music
Arm Description
Participants listen to music in the waiting room
Participants will not have music in the waiting room
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Perceived waiting time
Participants will be asked about perceived waiting time
Full Information
NCT ID
NCT03384576
First Posted
December 8, 2017
Last Updated
June 12, 2019
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT03384576
Brief Title
The Effect of Music in the Pediatric Emergency Department Waiting Room on Caregiver Anxiety
Official Title
The Effect of Music in the Pediatric Emergency Department Waiting Room on Caregiver Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 24, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Music, Emergency, caregivers
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music intervention
Arm Type
Experimental
Arm Description
Participants listen to music in the waiting room
Arm Title
No music
Arm Type
Active Comparator
Arm Description
Participants will not have music in the waiting room
Intervention Type
Other
Intervention Name(s)
Music intervention
Intervention Description
Classical music to be played in the Emergency waiting room
Intervention Type
Other
Intervention Name(s)
No music
Intervention Description
No music played in emergency waiting room
Primary Outcome Measure Information:
Title
reduction in anxiety score
Description
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 Outcome Measure Information:
Title
Perceived waiting time
Description
Participants will be asked about perceived waiting time
Time Frame
up to 10 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer M Smedley, DO
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Music in the Pediatric Emergency Department Waiting Room on Caregiver Anxiety
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