Risk of Falls in Patients Attending Music Sessions on an Acute Geriatric Ward

November 17, 2017 updated by: Shek Fung, McGill University

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
152

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • first admission to the GAU
  • length of stay between 5 and 31 days

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Music intervention Group
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.
Other: Music Session
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.
No Intervention: Control Group
Patients who did not want to participate to the music sessions provided by volunteers while being admitted to the geriatric assessment unit

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
At baseline (T0) and 4 weeks later (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMHC # 14-31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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