AnxietyNCT03384576
The Effect of Music in the Pediatric Emergency Department Waiting Room on Caregiver Anxiety
A study testing Music intervention and No music in people with Anxiety, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Music intervention and No music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-english speaking caregivers
- Hearing impaired caregivers
- Caregivers accompanying a patient with an acuity level less than 4
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
- Conditions
- Anxiety
- Being tested
- Music intervention, No music
- Keywords
- Music, Emergency, caregivers
- Medical subject headings
- Anxiety Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
Classical music to be played in the Emergency waiting room
No musicOther
No music played in emergency waiting room
| Study group | Role | What they receive |
|---|---|---|
| Music intervention | Experimental | Participants listen to music in the waiting room Receives: Other: Music intervention |
| No music | Active comparator | Participants will not have music in the waiting room Receives: Other: No music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 10 hours
Secondary outcomes (1)
Perceived waiting time
Participants will be asked about perceived waiting time
Measured: up to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start24 Jul 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Smedley, University of Alabama at Birmingham
- Investigators
- Jennifer M Smedley, DO, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384576
- Sponsor's protocol ID
- 300001035
- Status last verified
- Jun 2019
- First submitted
- 8 Dec 2017
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music in the Pediatric Emergency Department Waiting Room on Caregiver Anxiety
- ClinicalTrials.gov ID
- NCT03384576
- Acronym / sponsor ID
- 300001035
- Conditions
- Anxiety
- Keywords
- Music, Emergency, caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music intervention | Experimental | Other: Music interventionParticipants listen to music in the waiting room |
| No music | Active comparator | Other: No musicParticipants will not have music in the waiting room |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Non-english speaking caregivers
- Hearing impaired caregivers
- Caregivers accompanying a patient with an acuity level less than 4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionClassical music to be played in the Emergency waiting room | Other | Music intervention |
| No musicNo music played in emergency waiting room | Other | No music |
Primary outcome
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
1 secondary outcome
Perceived waiting time
Time frame: up to 10 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer M Smedley, DO principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention and No music in people with Anxiety, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in anxiety score (time frame: up to 10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.