- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04514432
Mindful Melody: Feasibility of Implementing Music Listening on an Inpatient Psychiatric Unit and Its Relation to the Use of As Needed Medications for Acute Agitation
Study Overview
Status
Intervention / Treatment
Detailed Description
The number of as-needed medications for agitation was quantified during a three month period during which patients had the option of listening to music in cases of agitation. This was compared to the number of medications needed for agitation during another 3 month period during which music was not available. The medications used were quantified using pharmacy records. Patients and nurses were surveyed to determine how effective and feasible they thought the music intervention was. The study was conducted at the SUNY Upstate University Hospital inpatient psychiatric unit, which is a 24-bed unit. 172 patients were included in the project.
Before starting to offer music, a basic training meeting was held with nursing staff to understand the purpose of the project. Patients participating had the option of selecting a preferred musical genre and they listened to music using wireless headphones. The playlists used were genre playlists automatically generated by Spotify music application. If patients did not like the song that was generated, they had an option to skip the song using their bluetooth headphone controls. Headphones were collected after 30 minutes of listening unless they were return prior to completion of the listening session.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13210
- Upstate University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any patient 18 years or older admitted to the inpatient psychiatric unit
Exclusion Criteria:
- Patients who did not want to listen to music or be included in the project were excluded
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
When music was available
3 month period during which music was available to patients experiencing agitation
|
If patients experienced agitation, they were able to request to listen to music for 30 minutes.
They listened to genre playlists generated by the music application Spotify.
|
When music was not available
3 month period during which music was not available to patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of medications used for agitation
Time Frame: 5/18/2018 until 11/13/2018
|
The number of different types of medications used for agitation was quantified using pharmacy records
|
5/18/2018 until 11/13/2018
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scales administered to nursing staff
Time Frame: 5/18/2018 until 11/13/2018
|
Scales administered to nursing to determine ease of implementation and effect on the psychiatric unit milieu
|
5/18/2018 until 11/13/2018
|
Scales administered to patients
Time Frame: 5/18/2018 until 11/13/2018
|
Scales administered to patients to assess the extent of the calming effect of listening to music
|
5/18/2018 until 11/13/2018
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1434789-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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