Musicians United for Seniors to Improve Care (MUSIC) Study

NCT ID: NCT03328793

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-26

Study Completion Date

2017-11-30

Brief Summary

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Music has a potential role in health care. In the geriatric population, music presents a non-pharmacological intervention which is easy to implement. Also, music has a potential role in order to improve patient's mobility. For example, it was also shown that the rhythmic component of music combined with physical exercise can improve gait variability which has been identified as a marker of gait instability and a fall predictor. This effect was previously shown in older community dwellers as a music-based intervention significantly improved gait and balance stability.

Considering that music was shown to have a positive impact on communication, emotions and depressive symptoms this intervention has the potential to make our patients more conscious of their environment, leading to an improved mobility.

Thus, the investigators hypothesize that patients who attend live music sessions (compared to controls) will demonstrate an improvement in their mobility measures. This effect could potentially be explained by the rhythmic effect of music and by the fact that live music sessions lead to an improved mood, communication, emotions, and an improved mobility.

* The primary objective of this study will be to determine if participation to live music sessions will be associated with an improvement in mobility which will be measured using the Times Up and Go (TUG) and gait speed when compared to a control group.
* The second objective of this study will be to determine if patients participating in live music sessions compared to a control group demonstrate an increase/improvement at the end of their music session in their mood (the Visual Analog Mood Scale (VAMS) will be used), in their positive emotions (the Observed Emotion Rating Scale (OERS) will be used) and communication behaviour (the CODEM (tool to assess communication behavior in dementia) instrument will be used).
* The third objective of this study will be to perform a "feasibility study". By measuring the variation in the different scales which will be used (see the third objective), the investigators will be able to determine how many participants will be necessary for an eventual larger scale study.

This will be a prospective open-label randomized control trial. The patients will be randomly assigned to a musical intervention or to a television intervention (control group). The patients will only attend one session in the context of this research project. Pre and post measures will be done.

Detailed Description

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Music has a potential role in health care. In patients with major neurocognitive impairment (previously called dementia), several studies have demonstrated that musical intervention can improve cognition, in particular spatial and temporal orientation, episodic memory and working memory. It was also shown that music may improve quality of life and reduce depressive symptoms, and there is growing evidence for the use of music to treat pain and anxiety.

When specifically looking at the geriatric population, music listening presents a non-pharmacological intervention which is easy to implement in inpatients with functional decline. It was shown to improve mood in both cognitively impaired and intact patients.

Music has a potential role in order to improve patient's mobility. For example, it was also shown that the rhythmic component of music combined with physical exercise can improve gait variability which has been identified as a marker of gait instability and a fall predictor. This effect was previously shown in older community dwellers as a music-based intervention significantly improved gait and balance stability.

Also, considering that music was shown to have a positive impact on communication, emotions and depressive symptoms, this intervention therefore has the potential to make our patients more conscious of their environment, leading to an improved mobility.

Thus, the investigators hypothesize that patients who attend live music sessions (compared to controls) will demonstrate an improvement in their mobility measures. This effect could potentially be explained by the rhythmic effect of music and by the fact that live music sessions lead to an improved mood, communication, emotions, and an improved mobility.

* The primary objective of this study will be to determine if participation to live music sessions will be associated with an improvement in mobility which will be measured using the Times Up and Go (TUG) and gait speed when compared to a control group.
* The second objective of this study will be to determine if patients participating in live music sessions compared to a control group demonstrate an increase/improvement at the end of their music session in their mood (the Visual Analog Mood Scale (VAMS) will be used), in their positive emotions (the Observed Emotion Rating Scale (OERS) will be used) and communication behaviour (the CODEM instrument will be used).
* The third objective of this study will be to perform a "feasibility study". By measuring the variation in the different scales which will be used (see the third objective), the investigators will be able to determine how many participants will be necessary for an eventual larger scale study.

This will be a prospective open-label randomized control trial. The patients will be randomly assigned to a musical intervention or to a television intervention (control group). The patients will only attend one session in the context of this research project. Pre and post measures will be done.

Conditions

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Music Gait Emotions Communication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
The research assistant who will be doing the Visual Analog Mood Scale (VAMS) with the patients pre and post intervention will be blinded in regards to the group attribution of the patient.

Study Groups

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Music Intervention (Intervention Group)

The patients will assist to a live music session of 30 minutes which will be given by musicians (volunteers) and will undergo:

* mood assessment
* emotion assessment
* mobility assessment
* communication assessment

Group Type EXPERIMENTAL

Mood Assessment

Intervention Type BEHAVIORAL

Prior to and after the session, the patients will be asked to fill a VAMS (Visual Analog Mood Scale).

Emotion Assessment

Intervention Type BEHAVIORAL

During the sessions, the patients will be videotaped and the videotapes will be reviewed by 2 independent research assistants. With the use of the Observed Emotional Rating Scale (OERS), the research assistants will be able to assess the patients's emotions at the beginning and at the end of the session (they will analyse the first 10 and the last 10 minutes of the sessions).

Communication Assessment

Intervention Type BEHAVIORAL

During the sessions, the patients will be videotaped and the videotapes will be reviewed by 2 independent research assistants. With the use of the CODEM Scale, the research assistants will be able to assess the patients's emotions at the beginning and at the end of the session (they will analyse the first 10 and the last 10 minutes of the sessions).

Mobility assessment

Intervention Type OTHER

If deemed to be safe, the patients will undergo a gait speed assessment as well as a TUG (timed-up-and-go) prior to and after the sessions

Music Intervention

Intervention Type OTHER

The participants will listen to a 30 minute live music sessions which will be given by musicians (who is a volunteer)

Documentary watching (Control Group)

The patients will watch a documentary for 30 minutes in the presence of a volunteer and will undergo:

* mood assessment
* emotion assessment
* mobility assessment
* communication assessment

Group Type ACTIVE_COMPARATOR

Mood Assessment

Intervention Type BEHAVIORAL

Prior to and after the session, the patients will be asked to fill a VAMS (Visual Analog Mood Scale).

Emotion Assessment

Intervention Type BEHAVIORAL

During the sessions, the patients will be videotaped and the videotapes will be reviewed by 2 independent research assistants. With the use of the Observed Emotional Rating Scale (OERS), the research assistants will be able to assess the patients's emotions at the beginning and at the end of the session (they will analyse the first 10 and the last 10 minutes of the sessions).

Communication Assessment

Intervention Type BEHAVIORAL

During the sessions, the patients will be videotaped and the videotapes will be reviewed by 2 independent research assistants. With the use of the CODEM Scale, the research assistants will be able to assess the patients's emotions at the beginning and at the end of the session (they will analyse the first 10 and the last 10 minutes of the sessions).

Mobility assessment

Intervention Type OTHER

If deemed to be safe, the patients will undergo a gait speed assessment as well as a TUG (timed-up-and-go) prior to and after the sessions

Documentary watching

Intervention Type OTHER

The patients will watch a documentary for 30 minutes in the presence of a volunteer

Interventions

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Mood Assessment

Prior to and after the session, the patients will be asked to fill a VAMS (Visual Analog Mood Scale).

Intervention Type BEHAVIORAL

Emotion Assessment

During the sessions, the patients will be videotaped and the videotapes will be reviewed by 2 independent research assistants. With the use of the Observed Emotional Rating Scale (OERS), the research assistants will be able to assess the patients's emotions at the beginning and at the end of the session (they will analyse the first 10 and the last 10 minutes of the sessions).

Intervention Type BEHAVIORAL

Communication Assessment

During the sessions, the patients will be videotaped and the videotapes will be reviewed by 2 independent research assistants. With the use of the CODEM Scale, the research assistants will be able to assess the patients's emotions at the beginning and at the end of the session (they will analyse the first 10 and the last 10 minutes of the sessions).

Intervention Type BEHAVIORAL

Mobility assessment

If deemed to be safe, the patients will undergo a gait speed assessment as well as a TUG (timed-up-and-go) prior to and after the sessions

Intervention Type OTHER

Music Intervention

The participants will listen to a 30 minute live music sessions which will be given by musicians (who is a volunteer)

Intervention Type OTHER

Documentary watching

The patients will watch a documentary for 30 minutes in the presence of a volunteer

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients admitted to the Geriatric Assessment Unit of St. Mary's Hospital.
* Patients interested in participating in this research (recreational) study

Exclusion Criteria

* Patients who are medically unstable to attend the music or television-watching sessions will be excluded from the study.
* Also, if patients are deemed to be unsafe by the medical team to undergo a TUG or a gait speed assessment, those measures will not be collected. Those patients would therefore only fill a pre- and post VAMS and attend the musical or television session.
* Finally, the investigators will only consider the first participation to a session in our analysis. In other words, patients who have already participated to a music session prior to the initiation of this study will be excluded (will not be recruited into the study).
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McGill University

OTHER

Sponsor Role lead

Responsible Party

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Shek Fung

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. Mary's Hospital Center

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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SMHC 14-31B

Identifier Type: -

Identifier Source: org_study_id

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