DeliriumNCT03980782
The Effect of Music Therapy on Delirium
A study testing Music Therapy in people with Delirium, run by Geisinger Clinic at 1 site in United States.
Trial summary
The purpose of this study is to test the effect of a twice daily, 30-minute, interdisciplinary, music therapist developed, nurse initiated, music listening intervention on acutely ill older patients as compared to patients who receive care as usual. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2019to 30 Sep 2019
- 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
- Age 65 or older Admitted to the Progressive Care Unit (PCU), must be able to speak English Must be able to hear music through headphones. Must not have a documented history of dementia Must not have a documented history of permanent cognitive impairment, Must not be delirious at the beginning of the study (CAM negative) Must be able to sign a consent form.
Who cannot join
- Age less than 65, Not admitted to the Progressive Care Unit, Positive for delirium (CAM positive) Does not speak English, Has a hearing impairment, Documented history of dementia Documented history of permanent cognitive decline Expected death within 24 hours of enrollment, Transferred off the floor Unable to sign consent.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Music Intervention on the Incidence, Severity and Duration of Delirium in Older Acute Care Patients
The purpose of this study is to test the effect of a twice daily, 30-minute, interdisciplinary, music therapist developed, nurse initiated, music listening intervention on acutely ill older patients as compared to patients who receive care as usual. Half of the participants will receive music therapy and the other half will receive care as usual.
Read the detailed description
Delirium is a complex, preventable, neuropsychiatric syndrome that is associated with higher mortality rates post discharge, increased hospital stays, increased mortality and an increased risk for developing dementia. Early, nonpharmacological treatment of delirium is preferable and supported by the literature to preserve patient safety. Music therapy is an evidence based, goal directed treatment process in which the music therapist and the patient maintain a state of well-being to achieve individualized patient goals. Music interventions are therapist developed and nurse initiated, in accordance to individual patient needs to maintain well-being, and show promise for improving attention and engagement. Understanding the effect of an individualized music intervention on the incidence, duration and severity of delirium has the potential to facilitate the use of cost-effective methods to modify individual environments to deliver appropriate care for acutely ill older adults. Purpose: The purpose of this study is to test the effect of an interdisciplinary music intervention on the incidence, severity and duration of delirium in older acutely ill adults. Methods: A randomized control pilot study will be used to test the effect of a music therapist-developed, music listening intervention on delirium. Acutely ill patients will be randomized into a usual care control group or an experimental group receiving the music intervention twice daily for 30 minutes. Data analysis: Descriptive statistics will be used to describe the sample. Independent t-tests will be used to examine group differences in delirium severity and duration. Chi-square analysis will be used to assess group differences in delirium incidence. Implications: For patients exposed to the stress of hospitalization, a music intervention may enhance delirium care and promote care that is safe and efficient.
- Conditions
- Delirium
- Being tested
- Music Therapy
- Keywords
- Delirium elderly Music therapy, Elderly, Music Therapy
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
Individualized music therapy developed playlist(s) that will be used based upon the latest Confusion Assessment Method result (hypoactive, hyperactive or no delirium) delivered twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Music Intervention | Experimental | Each participant will receive a 30 minute individual music intervention twice daily. Receives: Other: Music Therapy |
| Care as usual | No intervention | Each participant will receive care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of Music Therapy on the Incidence of Delirium in Older Acute Care Patients.
The incidence of delirium will be measured twice a day with the Confusion Assessment Method (CAM).
Measured: 2-3 months
Secondary outcomes (1)
The Effect of a Music Intervention on the Severity of Delirium in Older Acute Care Patients
The severity of Delirium will be determined using the Confusion Assessment Method- S (CAM-S assessment) twice a day once participants are CAM positive. The CAM-S, rate each symptom of delirium listed in the short CAM instrument as absent (0), mild (1), marked (2). Acute onset or fluctuation is rated as absent or present. Summarize these scores into a composite that ranges from 0-7 (higher scores indicate more severe delirium).
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start5 Jun 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized control pilot study will be used to test the effect of a music therapist-developed, music listening intervention on delirium. Acutely ill patients will be randomized into a usual care control group or an experimental group receiving the music intervention twice daily for 30 minutes.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Kovaleski, Geisinger Clinic
- Investigators
- Adele Spegman, PhD, Study director, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980782
- Sponsor's protocol ID
- 2019-0319
- Status last verified
- Dec 2019
- First submitted
- 4 Jun 2019
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Music Intervention on the Incidence, Severity and Duration of Delirium in Older Acute Care Patients
- ClinicalTrials.gov ID
- NCT03980782
- Acronym / sponsor ID
- 2019-0319
- Conditions
- Delirium
- Keywords
- Delirium elderly Music therapy, Elderly, Music Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 10 Jun 2019 (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.
The purpose of this study is to test the effect of a twice daily, 30-minute, interdisciplinary, music therapist developed, nurse initiated, music listening intervention on acutely ill older patients as compared to patients who receive care as usual. Half of the participants will receive music therapy and the other half will receive care as usual.
Detailed description
Delirium is a complex, preventable, neuropsychiatric syndrome that is associated with higher mortality rates post discharge, increased hospital stays, increased mortality and an increased risk for developing dementia. Early, nonpharmacological treatment of delirium is preferable and supported by the literature to preserve patient safety. Music therapy is an evidence based, goal directed treatment process in which the music therapist and the patient maintain a state of well-being to achieve individualized patient goals. Music interventions are therapist developed and nurse initiated, in accordance to individual patient needs to maintain well-being, and show promise for improving attention and engagement. Understanding the effect of an individualized music intervention on the incidence, duration and severity of delirium has the potential to facilitate the use of cost-effective methods to modify individual environments to deliver appropriate care for acutely ill older adults. Purpose: The purpose of this study is to test the effect of an interdisciplinary music intervention on the incidence, severity and duration of delirium in older acutely ill adults. Methods: A randomized control pilot study will be used to test the effect of a music therapist-developed, music listening intervention on delirium. Acutely ill patients will be randomized into a usual care control group or an experimental group receiving the music intervention twice daily for 30 minutes. Data analysis: Descriptive statistics will be used to describe the sample. Independent t-tests will be used to examine group differences in delirium severity and duration. Chi-square analysis will be used to assess group differences in delirium incidence. Implications: For patients exposed to the stress of hospitalization, a music intervention may enhance delirium care and promote care that is safe and efficient.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized control pilot study will be used to test the effect of a music therapist-developed, music listening intervention on delirium. Acutely ill patients will be randomized into a usual care control group or an experimental group receiving the music intervention twice daily for 30 minutes.
| Arm | Type | Receives |
|---|---|---|
| Music Intervention | Experimental | Other: Music TherapyEach participant will receive a 30 minute individual music intervention twice daily. |
| Care as usual | No intervention | –Each participant will receive care as usual. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age 65 or older Admitted to the Progressive Care Unit (PCU), must be able to speak English Must be able to hear music through headphones. Must not have a documented history of dementia Must not have a documented history of permanent cognitive impairment, Must not be delirious at the beginning of the study (CAM negative) Must be able to sign a consent form.
Key exclusion criteria (2 listed)
- Age less than 65, Not admitted to the Progressive Care Unit, Positive for delirium (CAM positive) Does not speak English, Has a hearing impairment, Documented history of dementia Documented history of permanent cognitive decline Expected death within 24 hours of enrollment, Transferred off the floor Unable to sign consent.
- -
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 TherapyIndividualized music therapy developed playlist(s) that will be used based upon the latest Confusion Assessment Method result (hypoactive, hyperactive or no delirium) delivered twice daily. | Other | Music Intervention |
Primary outcome
The effect of Music Therapy on the Incidence of Delirium in Older Acute Care Patients.
Time frame: 2-3 months
The incidence of delirium will be measured twice a day with the Confusion Assessment Method (CAM).
1 secondary outcome
The Effect of a Music Intervention on the Severity of Delirium in Older Acute Care Patients
Time frame: 2-3 months
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 2 Jun 2020.
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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.
Adele Spegman, PhD study director
Geisinger Clinic
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 Therapy in people with Delirium, run by Geisinger Clinic at 1 site in United States.
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 1 inclusion and 2 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 2 Jun 2020. 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 United States. 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?
The effect of Music Therapy on the Incidence of Delirium in Older Acute Care Patients. (time frame: 2-3 months). 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 2 Jun 2020.