Clinical trial NCT03328793: Musicians United for Seniors to Improve Care (MUSIC) Study
Official title: Musicians United for Seniors to Improve Care (MUSIC) Study - Open Randomized Controlled Clinical Trial Examining the Effect of Live Music Sessions on Health Condition of Geriatric Inpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Music
Gait
Emotions
Communication
Keywords: music
gait
emotions
communication
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline Timed up and Go (measured in seconds) compared to after completion of the session.
timeFrame: At baseline (T0), and within 5 minutes of completion of the intervention session (T1)
measure: Change from baseline Gait speed (measured in seconds) compared to after completion of the session.
timeFrame: At baseline (T0), and within 5 minutes of completion of the intervention session (T1)
Secondary outcomes:
measure: Change from baseline Visual Analog Mood Scale compared to after completion of the session.
timeFrame: At baseline (T0), and within 5 minutes of completion of the intervention session (T1)
measure: Change in the Observed Emotional Rating Scale at the beginning of the session compared to the end of the session.
timeFrame: Start of intervention session and end of intervention session (i.e the first 10 minutes and last 10 minutes of videotaped sessions)
measure: Change in Communication Skills at the beginning of the session compared to the end of the session.
timeFrame: Start of intervention session and end of intervention session (i.e the first 10 minutes and last 10 minutes of videotaped sessions)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: St. Mary's Hospital Center
state: Quebec
Study officials:
References: