FallNCT03348657
Risk of Falls in Patients Attending Music Sessions on an Acute Geriatric Ward
A study testing Music Session in people with Fall and Music, run by McGill University at 1 site in Canada.
Trial summary
Music therapy has long been used to improve communication, health and quality of life. Music is also known to regulate pain, mood and anxiety levels. In the geriatric population, music listening has been shown to decrease depressive symptoms and neuropsychiatric symptoms such as agitation and anxiety. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Music Session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2014to 31 May 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- first admission to the GAU
- length of stay between 5 and 31 days
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decreased Risk of Falls in Patients Attending Music Sessions on an Acute Geriatric Ward
Music therapy has long been used to improve communication, health and quality of life. Music is also known to regulate pain, mood and anxiety levels. In the geriatric population, music listening has been shown to decrease depressive symptoms and neuropsychiatric symptoms such as agitation and anxiety. As a result, the use of music is recommended by national guidelines to control the behavioural symptoms of patients in long-term care facilities. Despite the demonstrated positive benefits of music for health and behavioural outcomes, very few studies using music have been performed in the hospital environment and even fewer on short-stay geriatric units.
Older adults are the fastest-growing group of patients admitted to hospital, and the age-related burden of non-fatal health outcomes is one of the main challenges faced by hospitals. One of those age-related burdens is related to falls. Falls are highly frequent in geriatric patients, particularly on short-stay geriatric units, with a prevalence of up to 30 %. Falls are associated with increased length of hospital stay, high health-care costs and negative non-fatal health outcomes including multi-morbidities and related disabilities.
Read more
Previous research has shown that music may decrease the risk of falls. For example, it was shown that the rhythm of music, combined with physical exercise, can improve measures of gait stability. In older community dwellers, music-based programs have demonstrated that improvement of gait stability decreased the risk of falls. We therefore hypothesized that music listening may decrease the risk of falls of geriatric patients admitted to a short stay unit.
This study aimed to examine the influence of music listening on the risk of falls in patients admitted to a Geriatric Assessment Unit (GAU) by comparing the Morse Fall Scale (MFS) score for patients who attended music listening sessions and in control patients who did not attend these music sessions. To our knowledge, this is the first study to assess the effect of music listening on the risk of falls in a geriatric unit.
Read the detailed description
Music is often used as a non-verbal means of emotional expression. As communication can be impaired in the elderly due to cognitive impairment and diseases, music can be used to recreate communication between the patients and their environment. Music therapy has long been used to improve communication, health and quality of life. Music is also known to regulate pain, mood and anxiety levels. In the geriatric population, music listening has been shown to decrease depressive symptoms and neuropsychiatric symptoms such as agitation and anxiety. As a result, the use of music is recommended by national guidelines to control the behavioural symptoms of patients in long-term care facilities. Despite the demonstrated positive benefits of music for health and behavioural outcomes, very few studies using music have been performed in the hospital environment and even fewer on short-stay geriatric units.
Older adults are the fastest-growing group of patients admitted to hospital, and the age-related burden of non-fatal health outcomes is one of the main challenges faced by hospitals. Thus, assessing and addressing the needs of the growing number of geriatric patients is necessary. One of those age-related burdens is related to falls. Falls are highly frequent in geriatric patients, particularly on short-stay geriatric units, with a prevalence of up to 30 %. Falls are associated with increased length of hospital stay, high health-care costs and negative non-fatal health outcomes including multi-morbidities and related disabilities.
Previous research has shown that music may decrease the risk of falls. For example, it was shown that the rhythm of music, combined with physical exercise, can improve measures of gait stability. In older community dwellers, music-based programs have demonstrated that improvement of gait stability decreased the risk of falls. We therefore hypothesized that music listening may decrease the risk of falls of geriatric patients admitted to a short stay unit.
This study aimed to examine the influence of music listening on the risk of falls in patients admitted to a Geriatric Assessment Unit (GAU) by comparing the Morse Fall Scale (MFS) score for patients who attended music listening sessions and in control patients who did not attend these music sessions. To our knowledge, this is the first study to assess the effect of music listening on the risk of falls in a geriatric unit.
- Being tested
- Music Session
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music SessionOther
Three to four times a week, volunteer musicians came to the geriatric assessment unit and would provide music sessions (duration of about 60 minutes) to the patients who volunteered to attend.
| Study group | Role | What they receive |
|---|---|---|
| Music intervention Group | Other | Patients who participated to at least one music session provided by volunteers while being admitted to the geriatric assessment unit. Participation to the music sessions was voluntary. Receives: Other: Music Session |
| Control Group | No intervention | Patients who did not want to participate to the music sessions provided by volunteers while being admitted to the geriatric assessment unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the risk of fall
The Morse Fall Scale (MFS). This is a rapid and simple method to assess the probability that a patient will fall. The total score is out of 125 and includes 6 items: history of previous falls, presence of a secondary diagnosis (i.e. more than one medical diagnosis in the patient's chart), use of an ambulatory aid (none, cane, walker), presence of intravenous therapy, gait and transfers (normal, weak, impaired) and the patient's mental status (oriented towards own ability or not). The score is further divided into 3 risk levels: low risk (less than 25 points), medium risk (25-44 points) and high risk (more than 45 points).
Measured: At baseline (T0) and 4 weeks later (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start1 Oct 2014
- Primary completion31 May 2016
- Study completion31 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 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
- NCT03348657
- Sponsor's protocol ID
- SMHC # 14-31
- Status last verified
- Nov 2017
- First submitted
- 13 Nov 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chabot J, Beauchet O, Fung S, Peretz I. Decreased risk of falls in patients attending music sessions on an acute geriatric ward: results from a retrospective cohort study. BMC Complement Altern Med. 2019 Mar 28;19(1):76. doi: 10.1186/s12906-019-2484-x.
PubMed 30922356
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreased Risk of Falls in Patients Attending Music Sessions on an Acute Geriatric Ward
- ClinicalTrials.gov ID
- NCT03348657
- Acronym / sponsor ID
- SMHC # 14-31
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 21 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 therapy has long been used to improve communication, health and quality of life. Music is also known to regulate pain, mood and anxiety levels. In the geriatric population, music listening has been shown to decrease depressive symptoms and neuropsychiatric symptoms such as agitation and anxiety. As a result, the use of music is recommended by national guidelines to control the behavioural symptoms of patients in long-term care facilities. Despite the demonstrated positive benefits of music for health and behavioural outcomes, very few studies using music have been performed in the hospital environment and even fewer on short-stay geriatric units.
Older adults are the fastest-growing group of patients admitted to hospital, and the age-related burden of non-fatal health outcomes is one of the main challenges faced by hospitals. One of those age-related burdens is related to falls. Falls are highly frequent in geriatric patients, particularly on short-stay geriatric units, with a prevalence of up to 30 %. Falls are associated with increased length of hospital stay, high health-care costs and negative non-fatal health outcomes including multi-morbidities and related disabilities.
Previous research has shown that music may decrease the risk of falls. For example, it was shown that the rhythm of music, combined with physical exercise, can improve measures of gait stability. In older community dwellers, music-based programs have demonstrated that improvement of gait stability decreased the risk of falls. We therefore hypothesized that music listening may decrease the risk of falls of geriatric patients admitted to a short stay unit.
This study aimed to examine the influence of music listening on the risk of falls in patients admitted to a Geriatric Assessment Unit (GAU) by comparing the Morse Fall Scale (MFS) score for patients who attended music listening sessions and in control patients who did not attend these music sessions. To our knowledge, this is the first study to assess the effect of music listening on the risk of falls in a geriatric unit.
Detailed description
Music is often used as a non-verbal means of emotional expression. As communication can be impaired in the elderly due to cognitive impairment and diseases, music can be used to recreate communication between the patients and their environment. Music therapy has long been used to improve communication, health and quality of life. Music is also known to regulate pain, mood and anxiety levels. In the geriatric population, music listening has been shown to decrease depressive symptoms and neuropsychiatric symptoms such as agitation and anxiety. As a result, the use of music is recommended by national guidelines to control the behavioural symptoms of patients in long-term care facilities. Despite the demonstrated positive benefits of music for health and behavioural outcomes, very few studies using music have been performed in the hospital environment and even fewer on short-stay geriatric units.
Older adults are the fastest-growing group of patients admitted to hospital, and the age-related burden of non-fatal health outcomes is one of the main challenges faced by hospitals. Thus, assessing and addressing the needs of the growing number of geriatric patients is necessary. One of those age-related burdens is related to falls. Falls are highly frequent in geriatric patients, particularly on short-stay geriatric units, with a prevalence of up to 30 %. Falls are associated with increased length of hospital stay, high health-care costs and negative non-fatal health outcomes including multi-morbidities and related disabilities.
Previous research has shown that music may decrease the risk of falls. For example, it was shown that the rhythm of music, combined with physical exercise, can improve measures of gait stability. In older community dwellers, music-based programs have demonstrated that improvement of gait stability decreased the risk of falls. We therefore hypothesized that music listening may decrease the risk of falls of geriatric patients admitted to a short stay unit.
This study aimed to examine the influence of music listening on the risk of falls in patients admitted to a Geriatric Assessment Unit (GAU) by comparing the Morse Fall Scale (MFS) score for patients who attended music listening sessions and in control patients who did not attend these music sessions. To our knowledge, this is the first study to assess the effect of music listening on the risk of falls in a geriatric unit.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music intervention Group | Other | Other: Music SessionPatients who participated to at least one music session provided by volunteers while being admitted to the geriatric assessment unit. Participation to the music sessions was voluntary. |
| Control Group | No intervention | –Patients who did not want to participate to the music sessions provided by volunteers while being admitted to the geriatric assessment unit |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- first admission to the GAU
- length of stay between 5 and 31 days
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Music SessionThree to four times a week, volunteer musicians came to the geriatric assessment unit and would provide music sessions (duration of about 60 minutes) to the patients who volunteered to attend. | Other | Music intervention Group |
Primary outcome
Change in the risk of fall
Time frame: At baseline (T0) and 4 weeks later (T1)
The Morse Fall Scale (MFS). This is a rapid and simple method to assess the probability that a patient will fall. The total score is out of 125 and includes 6 items: history of previous falls, presence of a secondary diagnosis (i.e. more than one medical diagnosis in the patient's chart), use of an ambulatory aid (none, cane, walker), presence of intravenous therapy, gait and transfers (normal, weak, impaired) and the patient's mental status (oriented towards own ability or not). The score is further divided into 3 risk levels: low risk (less than 25 points), medium risk (25-44 points) and high risk (more than 45 points).
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 21 Nov 2017.
- Derived from this study: PubMed 30922356Chabot J, Beauchet O, Fung S, Peretz I. Decreased risk of falls in patients attending music sessions on an acute geriatric ward: results from a retrospective cohort study. BMC Complement Altern Med. 2019 Mar 28;19(1):76. doi: 10.1186/s12906-019-2484-x.
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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 Music Session in people with Fall and Music, 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 1 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 21 Nov 2017. 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 in the risk of fall (time frame: At baseline (T0) and 4 weeks later (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03348657, which also lists 1 linked publication.
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 21 Nov 2017.