ClinicalTrials.gg
CompletedNCT03328793MUSICUpdated Apr 5, 2018

Musicians United for Seniors to Improve Care (MUSIC) Study

An interventional study of Mood Assessment and Emotion Assessment in Music, Gait and Emotions, sponsored by McGill University. Completed at 1 site in Canada. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-05.

Sponsored by McGill University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jun 2017, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Music
  • Gait
  • Emotions
  • Communication

Browse trials for

Keywords

  • music
  • gait
  • emotions
  • communication
03

In context

Communication

719 studies on the registry are indexed under Communication; 159 are open to participants now.

This study's enrollment of 36 is below the median of 144 across 571 interventional studies indexed under Communication.

Browse Communication studies →

Lead sponsor

McGill University is the lead sponsor of 249 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    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

    Behavioral: Mood Assessment · Behavioral: Emotion Assessment · Behavioral: Communication Assessment · Other: Mobility assessment · Other: Music Intervention

  • Active comparator
    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

    Behavioral: Mood Assessment · Behavioral: Emotion Assessment · Behavioral: Communication Assessment · Other: Mobility assessment · Other: Documentary watching

Interventions

  • BehavioralMood Assessment

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

  • BehavioralEmotion 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).

  • BehavioralCommunication 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).

  • OtherMobility 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

  • OtherMusic Intervention

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

  • OtherDocumentary watching

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

06

What researchers measure

Primary outcomes

  1. Change from baseline Timed up and Go (measured in seconds) compared to after completion of the session.

    Measure of mobility, uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. Has excellent interrater (intraclass correlation coefficient \[ICC\] = .99) and intrarater reliability (ICC = .99)

    Time frame: At baseline (T0), and within 5 minutes of completion of the intervention session (T1)

  2. Change from baseline Gait speed (measured in seconds) compared to after completion of the session.

    Measure of mobility, measures time that a person takes to walk 3 meters at their comfortable pace in a quiet, well-lit corridor wearing their own footwear. In order to avoid acceleration and deceleration effects, participants will start walking one meter before the "start line" and will walk one meter beyond the "finish line".

    Time frame: At baseline (T0), and within 5 minutes of completion of the intervention session (T1)

Secondary outcomes

  1. Change from baseline Visual Analog Mood Scale compared to after completion of the session.

    Evaluation of 8 moods (happy, afraid, confused, sad, angry, energetic, tired and tense) with the use of schematic faces connected by a 100-mm vertical line. The top picture depicts a neutral mood face, while each of the eight scales are depicted below. The patients are asked to draw a line across the 100-mm vertical line to represent their current mood state.

    Time frame: At baseline (T0), and within 5 minutes of completion of the intervention session (T1)

  2. Change in the Observed Emotional Rating Scale at the beginning of the session compared to the end of the session.

    Consists of an observational tool including 2 positive emotions (pleasure and general alertness) and three negative emotions (anger, anxiety/fear, and sadness). The duration of each affect is measured over a ten-minute period and is graded from 1 to 5 (1 =never, 2 \< 16 seconds, 3 = 16-59 seconds, 4 = 1-4 minutes, and 5 = \>5 minutes). Will be used to code the first 10 minutes and last 10 minutes of videotaped sessions.

    Time frame: Start of intervention session and end of intervention session (i.e the first 10 minutes and last 10 minutes of videotaped sessions)

  3. Change in Communication Skills at the beginning of the session compared to the end of the session.

    The CODEM (tool to assess communication behavior in dementia) scales will be used. This scale requires a 10-minute observation-period of the participant and uses a scale from 0 to 5 to quantify the communication skills of the participants from 0 to 5 (0 = behavior is not shown during the interaction, 1 = behavior is rarely seen (1-24% during the interaction), 2 = behavior is shown in less than half (25-49%) of the interaction, 3 = behavior is shown in more than half (51-75%) of the interaction, 4 = behavior is shown in almost all (76-99%) interaction situations, and 5 = behavior is always shown (100%) during the interaction). It consists of 15 different items (8 verbal and 7 non-verbal items). For example, eye contact is a non-verbal item. Will be used to code the first 10 minutes and last 10 minutes of videotaped sessions.

    Time frame: Start of intervention session and end of intervention session (i.e the first 10 minutes and last 10 minutes of videotaped sessions)

07

Study locations

1 site
  • St. Mary's Hospital Center
    Montreal, Quebec H3T 1M5, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03328793
Lead sponsor
McGill University
Responsible party
Shek Fung (Principal Investigator, McGill University) — Principal investigator
First posted
Nov 1, 2017
Start date
Jun 26, 2017
Primary completion
Nov 30, 2017
Completion
Nov 30, 2017
Last update
Apr 5, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion