Music TherapyMUESNCT02363179
Music in the Emergency Department (ED): Phase II
A study testing Live preferential music in people with Music Therapy and Patient Satisfaction, run by University of Florida at 1 site in United States.
Trial summary
The investigators will conduct a prospective quasi-experimental design study of patients in the University of Florida Health Emergency Department. Live preferential music will be performed for patients in the emergency department on alternating days over 20 weeks, and subjects exposed to the music intervention will be… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Music Therapy, Patient Satisfaction
- What is being tested?
- Live preferential music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,107 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jun 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Language: english
- Cognitive skill/education: grade 2 reading level or above
Who cannot join
- Language: Non-english speaking
- Age: Less than 18
- Cognitive skill/education: lower than grade 2 reading level
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music in Urgent and Emergent Settings (MUES) Trial: Phase Two
The investigators will conduct a prospective quasi-experimental design study of patients in the University of Florida Health Emergency Department. Live preferential music will be performed for patients in the emergency department on alternating days over 20 weeks, and subjects exposed to the music intervention will be matched to a cohort that present to the emergency department on days with no music to assess impact on patient and healthcare provider satisfaction, pain medication utilization, length of stay, and cost of care.
Read the detailed description
Every year, over 130 million patients access emergency care in the US. Emergency Departments are high stress environments and are one of the significant drivers of high costs in healthcare. The prevalence of anxiety experienced by patients in the emergency department (ED) is abundant and substantial. Anxiety negatively affects the patient, the ED healthcare environment, and ED healthcare staff. Additionally, anxiety routinely results in the administration of medication that would be otherwise unnecessary, and contributes to the overall cost of healthcare and the stress of clinicians, particularly nursing staff. The University of Florida (UF) Department of Emergency Medicine, in partnership with the UF Center for Arts in Medicine, has recently completed phase one, and is proposing phase two, of a three-phase study to assess the impact of live preferential music on emergency department operations, including pain medication utilization and cost of care. The investigators propose to expand on the phase one pilot study to conduct a full randomized controlled study utilizing a group of highly talented musicians to provide live preferential music in our ED and level one trauma center setting. The project, the first systematic investigation of its kind, seeks to demonstrate that live preferential music in an emergency and trauma care setting can positively impact quality and cost of care.
- Conditions
- Music Therapy, Patient Satisfaction
- Being tested
- Live preferential music
- Keywords
- Emergency Service, Hospital
- Medical subject headings
- Patient Satisfaction, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live preferential musicBehavioural
Live preferential music will be performed for patients in the emergency department.
| Study group | Role | What they receive |
|---|---|---|
| Non Music Group | No intervention | 500 non-intervention patients will be consented to serve as the control group |
| Music Intervention Group | Experimental | 500 intervention patients will be consented to participate in the live preferential music intervention Receives: Behavioral: Live preferential music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Medication Utilization
Pain Medication Usage
Measured: 20 weeks
Secondary outcomes (1)
Cost of Care
Assessment of the chart associated cost per patient
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Music TherapyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of State Division Of Cultural Affairs, National Endowment for the Arts, United States
- Responsible party
- Sponsor
- Investigators
- Joseph A Tyndall, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363179
- Sponsor's protocol ID
- IRB201500083
- Other IDs
- 15-8503
- Acronym
- MUES
- Status last verified
- Jul 2017
- First submitted
- 9 Feb 2015
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rothrock SG, Johnson NE. Pain management in the pediatric emergency department. Pediatr Emerg Care. 1989 Dec;5(4):298. No abstract available.
PubMed 2602211Bengtsson SL, Ullen F, Ehrsson HH, Hashimoto T, Kito T, Naito E, Forssberg H, Sadato N. Listening to rhythms activates motor and premotor cortices. Cortex. 2009 Jan;45(1):62-71. doi: 10.1016/j.cortex.2008.07.002. Epub 2008 Oct 30.
PubMed 19041965Gallagher LM. The role of music therapy in palliative medicine and supportive care. Semin Oncol. 2011 Jun;38(3):403-6. doi: 10.1053/j.seminoncol.2011.03.010.
PubMed 21600370Good M. A comparison of the effects of jaw relaxation and music on postoperative pain. Nurs Res. 1995 Jan-Feb;44(1):52-7.
PubMed 7862546Good M, Stanton-Hicks M, Grass JA, Anderson GC, Lai HL, Roykulcharoen V, Adler PA. Relaxation and music to reduce postsurgical pain. J Adv Nurs. 2001 Jan;33(2):208-15. doi: 10.1046/j.1365-2648.2001.01655.x.
PubMed 11168704
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music in Urgent and Emergent Settings (MUES) Trial: Phase Two
- ClinicalTrials.gov ID
- NCT02363179
- Acronym / sponsor ID
- MUES / IRB201500083
- Conditions
- Music Therapy, Patient Satisfaction
- Keywords
- Emergency Service, Hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,107 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Florida Department of State Division Of Cultural Affairs, National Endowment for the Arts, United States
- Study start
- May 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 13 Feb 2015 (estimated)
- 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 investigators will conduct a prospective quasi-experimental design study of patients in the University of Florida Health Emergency Department. Live preferential music will be performed for patients in the emergency department on alternating days over 20 weeks, and subjects exposed to the music intervention will be matched to a cohort that present to the emergency department on days with no music to assess impact on patient and healthcare provider satisfaction, pain medication utilization, length of stay, and cost of care.
Detailed description
Every year, over 130 million patients access emergency care in the US. Emergency Departments are high stress environments and are one of the significant drivers of high costs in healthcare. The prevalence of anxiety experienced by patients in the emergency department (ED) is abundant and substantial. Anxiety negatively affects the patient, the ED healthcare environment, and ED healthcare staff. Additionally, anxiety routinely results in the administration of medication that would be otherwise unnecessary, and contributes to the overall cost of healthcare and the stress of clinicians, particularly nursing staff. The University of Florida (UF) Department of Emergency Medicine, in partnership with the UF Center for Arts in Medicine, has recently completed phase one, and is proposing phase two, of a three-phase study to assess the impact of live preferential music on emergency department operations, including pain medication utilization and cost of care. The investigators propose to expand on the phase one pilot study to conduct a full randomized controlled study utilizing a group of highly talented musicians to provide live preferential music in our ED and level one trauma center setting. The project, the first systematic investigation of its kind, seeks to demonstrate that live preferential music in an emergency and trauma care setting can positively impact quality and cost of care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Music Group | No intervention | –500 non-intervention patients will be consented to serve as the control group |
| Music Intervention Group | Experimental | Behavioral: Live preferential music500 intervention patients will be consented to participate in the live preferential music intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Language: english
- Cognitive skill/education: grade 2 reading level or above
Key exclusion criteria (3 listed)
- Language: Non-english speaking
- Age: Less than 18
- Cognitive skill/education: lower than grade 2 reading level
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 |
|---|---|---|
| Live preferential musicLive preferential music will be performed for patients in the emergency department. | Behavioural | Music Intervention Group |
Primary outcome
Pain Medication Utilization
Time frame: 20 weeks
Pain Medication Usage
1 secondary outcome
Cost of Care
Time frame: 20 weeks
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 6 Jul 2017.
- Background: PubMed 2602211Rothrock SG, Johnson NE. Pain management in the pediatric emergency department. Pediatr Emerg Care. 1989 Dec;5(4):298. No abstract available.
- Background: PubMed 19041965Bengtsson SL, Ullen F, Ehrsson HH, Hashimoto T, Kito T, Naito E, Forssberg H, Sadato N. Listening to rhythms activates motor and premotor cortices. Cortex. 2009 Jan;45(1):62-71. doi: 10.1016/j.cortex.2008.07.002. Epub 2008 Oct 30.
- Background: PubMed 21600370Gallagher LM. The role of music therapy in palliative medicine and supportive care. Semin Oncol. 2011 Jun;38(3):403-6. doi: 10.1053/j.seminoncol.2011.03.010.
- Background: PubMed 7862546Good M. A comparison of the effects of jaw relaxation and music on postoperative pain. Nurs Res. 1995 Jan-Feb;44(1):52-7.
- Background: PubMed 11168704Good M, Stanton-Hicks M, Grass JA, Anderson GC, Lai HL, Roykulcharoen V, Adler PA. Relaxation and music to reduce postsurgical pain. J Adv Nurs. 2001 Jan;33(2):208-15. doi: 10.1046/j.1365-2648.2001.01655.x.
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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.
Joseph A Tyndall, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live preferential music in people with Music Therapy and Patient Satisfaction, run by University of Florida 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 6 Jul 2017. 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?
Pain Medication Utilization (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02363179, which also lists 5 linked publications.
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 6 Jul 2017.