MusicMUSICNCT03328793
Musicians United for Seniors to Improve Care (MUSIC) Study
A study testing Mood Assessment, Emotion Assessment and Communication Assessment in people with Music and Gait, run by McGill University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- Mood Assessment, Emotion Assessment and Communication Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jun 2017to 30 Nov 2017
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients admitted to the Geriatric Assessment Unit of St. Mary's Hospital.
- Patients interested in participating in this research (recreational) study
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read more
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.
- Conditions
- Music, Gait, Emotions, Communication
- Being tested
- Mood Assessment, Emotion Assessment, Communication Assessment, Mobility assessment, Music Intervention
- Keywords
- music, gait, emotions, communication
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mood AssessmentBehavioural
Prior to and after the session, the patients will be asked to fill a VAMS (Visual Analog Mood Scale).
Emotion AssessmentBehavioural
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 AssessmentBehavioural
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 assessmentOther
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 InterventionOther
The participants will listen to a 30 minute live music sessions which will be given by musicians (who is a volunteer)
Documentary watchingOther
The patients will watch a documentary for 30 minutes in the presence of a volunteer
| Study group | Role | What they receive |
|---|---|---|
| Music Intervention (Intervention Group) | Experimental | 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 Receives: Behavioral: Mood Assessment; Behavioral: Emotion Assessment; Behavioral: Communication Assessment; Other: Mobility assessment; Other: Music Intervention |
| Documentary watching (Control Group) | Active comparator | 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 Receives: Behavioral: Mood Assessment; Behavioral: Emotion Assessment; Behavioral: Communication Assessment; Other: Mobility assessment; Other: Documentary watching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At baseline (T0), and within 5 minutes of completion of the intervention session (T1)
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".
Measured: At baseline (T0), and within 5 minutes of completion of the intervention session (T1)
Secondary outcomes (3)
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.
Measured: At baseline (T0), and within 5 minutes of completion of the intervention session (T1)
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.
Measured: Start of intervention session and end of intervention session (i.e the first 10 minutes and last 10 minutes of videotaped sessions)
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.
Measured: Start of intervention session and end of intervention session (i.e the first 10 minutes and last 10 minutes of videotaped sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start26 Jun 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MusicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shek Fung, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328793
- Sponsor's protocol ID
- SMHC 14-31B
- Acronym
- MUSIC
- Status last verified
- Apr 2018
- First submitted
- 13 Oct 2017
- Last updated
- 5 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03328793
- Acronym / sponsor ID
- MUSIC / SMHC 14-31B
- Conditions
- Music, Gait, Emotions, Communication
- Keywords
- music, gait, emotions, communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 1 Nov 2017 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Intervention (Intervention Group) | Experimental | Behavioral: Mood Assessment, Behavioral: Emotion Assessment, Behavioral: Communication Assessment, Other: Mobility assessment, Other: Music InterventionThe 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 |
| Documentary watching (Control Group) | Active comparator | Behavioral: Mood Assessment, Behavioral: Emotion Assessment, Behavioral: Communication Assessment, Other: Mobility assessment, Other: Documentary watchingThe 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients admitted to the Geriatric Assessment Unit of St. Mary's Hospital.
- Patients interested in participating in this research (recreational) study
Key exclusion criteria (3 listed)
- 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).
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 |
|---|---|---|
| Mood AssessmentPrior to and after the session, the patients will be asked to fill a VAMS (Visual Analog Mood Scale). | Behavioural | Documentary watching (Control Group), Music Intervention (Intervention Group) |
| Emotion AssessmentDuring 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). | Behavioural | Documentary watching (Control Group), Music Intervention (Intervention Group) |
| Communication AssessmentDuring 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). | Behavioural | Documentary watching (Control Group), Music Intervention (Intervention Group) |
| Mobility assessmentIf 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 | Other | Documentary watching (Control Group), Music Intervention (Intervention Group) |
| Music InterventionThe participants will listen to a 30 minute live music sessions which will be given by musicians (who is a volunteer) | Other | Music Intervention (Intervention Group) |
| Documentary watchingThe patients will watch a documentary for 30 minutes in the presence of a volunteer | Other | Documentary watching (Control Group) |
Primary outcome
Change from baseline Timed up and Go (measured in seconds) compared to after completion of the session.
Time frame: At baseline (T0), and within 5 minutes of completion of the intervention session (T1)
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)
Change from baseline Gait speed (measured in seconds) compared to after completion of the session.
Time frame: At baseline (T0), and within 5 minutes of completion of the intervention session (T1)
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".
3 secondary outcomes
Change from baseline Visual Analog Mood Scale compared to after completion of the session.
Time frame: At baseline (T0), and within 5 minutes of completion of the intervention session (T1)
Change in the Observed Emotional Rating Scale at the beginning of the session compared to the end of the session.
Time frame: Start of intervention session and end of intervention session (i.e the first 10 minutes and last 10 minutes of videotaped sessions)
Change in Communication Skills at the beginning of the session compared to the end of the session.
Time frame: Start of intervention session and end of intervention session (i.e the first 10 minutes and last 10 minutes of videotaped sessions)
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 5 Apr 2018.
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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?
A study testing Mood Assessment, Emotion Assessment and Communication Assessment in people with Music and Gait, run by McGill University at 1 site in Canada.
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 2 inclusion and 3 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 5 Apr 2018. 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 Canada. 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?
Change from baseline Timed up and Go (measured in seconds) compared to after completion of the session. (time frame: At baseline (T0), and within 5 minutes of completion of the intervention session (T1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2018.