NCT04514432

Brief 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. We hypothesized that music availability would help to reduce agitation and reduce the amount of as-needed medications used for cases of patient agitation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

August 12, 2020

Last Update Submit

August 12, 2020

Conditions

Keywords

AgitationMusicInpatient

Outcome Measures

Primary Outcomes (1)

  • The number of medications used for agitation

    The number of different types of medications used for agitation was quantified using pharmacy records

    5/18/2018 until 11/13/2018

Secondary Outcomes (2)

  • Scales administered to nursing staff

    5/18/2018 until 11/13/2018

  • Scales administered to patients

    5/18/2018 until 11/13/2018

Study Arms (2)

When music was available

3 month period during which music was available to patients experiencing agitation

Other: Music

When music was not available

3 month period during which music was not available to patients

Interventions

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.

When music was available

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

inpatients on an acute psychiatric unit

You may qualify if:

  • Any patient 18 years or older admitted to the inpatient psychiatric unit

You may not qualify if:

  • Patients who did not want to listen to music or be included in the project were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Upstate University Hospital

Syracuse, New York, 13210, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychomotor AgitationStress Disorders, Traumatic, Acute

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor of Psychiatry

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 17, 2020

Study Start

August 16, 2018

Primary Completion

November 16, 2018

Study Completion

November 16, 2018

Last Updated

August 17, 2020

Record last verified: 2020-08

Locations