Agitated; State, Acute Reaction to StressNCT04514432
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
An observational study of Agitated; State, Acute Reaction to Stress and Agitation,Psychomotor, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
In this quality improvement project, our objectives were to assess the feasibility and effectiveness of using music as an adjunct to or replacement of pharmacological interventions for patient agitation on an inpatient psychiatric unit. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Agitated; State, Acute Reaction to Stress, Agitation,Psychomotor
- What is being tested?
- Music
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2018to 16 Nov 2018
- Phase
- Observational
- 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
Study population: inpatients on an acute psychiatric unit
Who may be able to join
- Any patient 18 years or older admitted to the inpatient psychiatric unit
Who cannot join
- Patients who did not want to listen to music or be included in the project were excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Upstate University Hospital
Syracuse, New York, 13210
About this study
In this quality improvement project, our objectives were to assess the feasibility and effectiveness of using music as an adjunct to or replacement of pharmacological interventions for patient agitation on an inpatient psychiatric unit. We hypothesized that music availability would help to reduce agitation and reduce the amount of as-needed medications used for cases of patient agitation.
Read the 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.
- Being tested
- Music
- Keywords
- Agitation, Music, Inpatient
- Medical subject headings
- Psychomotor Agitation, Stress Disorders, Traumatic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| When music was available | 3 month period during which music was available to patients experiencing agitation Receives: Other: Music | |
| When music was not available | 3 month period during which music was not available to patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of medications used for agitation
The number of different types of medications used for agitation was quantified using pharmacy records
Measured: 5/18/2018 until 11/13/2018
Secondary outcomes (2)
Scales administered to nursing staff
Scales administered to nursing to determine ease of implementation and effect on the psychiatric unit milieu
Measured: 5/18/2018 until 11/13/2018
Scales administered to patients
Scales administered to patients to assess the extent of the calming effect of listening to music
Measured: 5/18/2018 until 11/13/2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start16 Aug 2018
- Primary completion16 Nov 2018
- Study completion16 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Agitated; State, Acute Reaction to StressStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luba Leontieva, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514432
- Sponsor's protocol ID
- 1434789-1
- Status last verified
- Aug 2020
- First submitted
- 12 Aug 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Scudamore T, Liem A, Wiener M, Ekure NS, Botash C, Empey D, Leontieva L. 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. BMC Psychiatry. 2021 Mar 6;21(1):132. doi: 10.1186/s12888-021-03127-z.
PubMed 33676455
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04514432
- Acronym / sponsor ID
- 1434789-1
- Keywords
- Agitation, Music, Inpatient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 17 Aug 2020 (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.
In this quality improvement project, our objectives were to assess the feasibility and effectiveness of using music as an adjunct to or replacement of pharmacological interventions for patient agitation on an inpatient psychiatric unit. We hypothesized that music availability would help to reduce agitation and reduce the amount of as-needed medications used for cases of patient agitation.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| When music was available | – | Other: Music3 month period during which music was available to patients experiencing agitation |
| When music was not available | – | –3 month period during which music was not available to patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- inpatients on an acute psychiatric unit
Key inclusion criteria (1 listed)
- Any patient 18 years or older admitted to the inpatient psychiatric unit
Key exclusion criteria (1 listed)
- Patients who did not want to listen to music or be included in the project were excluded
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 |
|---|---|---|
| MusicIf 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. | Other | When music was available |
Primary outcome
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
2 secondary outcomes
Scales administered to nursing staff
Time frame: 5/18/2018 until 11/13/2018
Scales administered to patients
Time frame: 5/18/2018 until 11/13/2018
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 17 Aug 2020.
- Derived from this study: PubMed 33676455Scudamore T, Liem A, Wiener M, Ekure NS, Botash C, Empey D, Leontieva L. 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. BMC Psychiatry. 2021 Mar 6;21(1):132. doi: 10.1186/s12888-021-03127-z.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Agitated; State, Acute Reaction to Stress and Agitation,Psychomotor, run by State University of New York - Upstate Medical University 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 1 inclusion and 1 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 17 Aug 2020. 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?
The number of medications used for agitation (time frame: 5/18/2018 until 11/13/2018). 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 NCT04514432, which also lists 1 linked publication.
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 17 Aug 2020.