Parkinson DiseaseNCT06063161
Music Therapy to Prevent Hospital-acquired Delirium in Parkinson's Disease and Dementia With Lewy Bodies
A study testing Music therapy intervention in people with Parkinson Disease and Dementia, Lewy Body, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The goal of this clinical trial is to test whether a music therapy intervention (MT) prevents hospital-acquired delirium (HaD) in patients with Parkinson's disease (PD) and Dementia with Lewy Bodies (DLB). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Parkinson Disease, Dementia, Lewy Body, Delirium
- What is being tested?
- Music therapy intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 1 Nov 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted as inpatient to UMass Memorial Medical Center University Campus
- Diagnosis of PD or DLB (ICD-10 G20 and G31.83 respectively) on active problem list or past medical history OR carbidopa/levodopa on active medication list or ordered in admission orders.
Who cannot join
- Severe hearing loss (unable to perceive sound < 71dB)
- Professed dislike or lack of reward with experiencing of all types of music (Barcelona Music Reward Questionnaire total score <40)
- History of musicogenic seizures
- Delirium present at initial assessment, as determined by a positive Confusion Assessment Method (CAM)
- Admitted to observation status or to Clinical Decision Unit (as these patients would not be expected to remain inpatient long enough to undergo the MT intervention)
- Patients who are currently prisoners will not be included
- Patients admitted and discharged within 24 hours.
- Patients in the intensive care unit receiving continuous intravenous sedative medication (as they would not be expected to be able to meaningfully participate in the study activities).
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Medical School/UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: Music Therapy for Hospitalized Patients With Parkinson's Disease and Lewy Body Dementia: A Randomized Controlled Pilot Trial to Prevent Delirium
The goal of this clinical trial is to test whether a music therapy intervention (MT) prevents hospital-acquired delirium (HaD) in patients with Parkinson's disease (PD) and Dementia with Lewy Bodies (DLB). Delirium is defined as a mental state in which you are confused, disoriented, and not able to think or remember clearly. It can start suddenly and is usually temporary. It is common among patients with PD/DLB during hospitalization.
We are conducting a randomized controlled feasibility pilot study of music therapy (MT) in patients with PD/DLB in the inpatient acute hospital setting.
Read more
We are testing if receiving music therapy lowers the risk of delirium, compared to other interventions. We are also testing if music therapy lowers the need for certain restraints and medications during the hospitalization.
Participants admitted to UMass Memorial Medical Center will be invited to participate. Participants will be asked to undergo a music therapy intervention for 30 minutes 3 times per week, and to listen to personalized music playlists for 60 minutes 4 times per week. Participants will be assessed for HaD every 24 hours, and will undergo additional surveys and questionnaires.
Researchers will compare the music therapy intervention to two another comparison groups: one group assigned to listen to music on their own, and one group assigned to receive only standard treatments. About one-third of the participants will be assigned to each of the three study groups.
Read the detailed description
Participants will be screened within 24 hours of inpatient admission to UMass Memorial Medical Center, University Campus (Worcester, MA).
Participants will be randomized equally to one of three groups: 1) Music therapy (MT), 2) Active Control, 3) Standard of Care.
Participants will receive the assigned intervention within 48 hours of admission, and this will continue up to the day of discharge. If a participant remains hospitalized for more than 15 days, the assigned intervention will stop at Day 15.
The study groups are described below:
MT arm:
Participants will undergo one-on-one music therapy sessions of approximately 30 minutes duration, beginning within 48 hours of admission. Sessions will occur 3 times/week. Sessions will be conducted by a board-certified music therapist. Sessions will be customized to address patient needs but will consistently adhere to the four principal MT methods of re-creation, composition, improvisation, and therapeutic listening experiences. Sessions will be responsive to patient preferences, culture, and identity.
A research assistant will supervise and document details of each session on a validated intervention log, for instance time spent on each MT method, type of music utilized, and whether family was involved.
Participants will also receive a music "booster" of daily playlist listening. Developed by the music therapist, two 30-minute personalized playlists will be created taking into consideration the individual's preferences and level of function and cognition. One playlist will be developed to up-regulate alertness to improve orientation and participation in therapies and interventions, and a second playlist will be designed to down-regulate for relaxation/sleep and decreasing agitation. Playlists will be played for 30 minutes each daily (60 minutes total/day) using an iPad and either a speaker or noise cancelling headphones (depending on patient preference and music therapist recommendations) provided by the study team.
At study completion (date of discharge or Day 15 of hospitalization) +/- 2 days we will conduct semi-structured interviews with participants who received MT, and/or healthcare proxy/LAR, to understand perceptions of the MT program.
Active Control arm:
Those assigned to the active control arm will listen to music playlists for 30 min twice a day (1 hr total/day) 3x/week. Playlists will be generated automatically based on popular genres and not personalized. Participants will listen on an iPad using either a speaker or noise cancelling headphones (depending on patient preference and music therapist recommendations).Listening sessions will continue up to Day 15 of admission or until patient is discharged. During this time, routine orders for music therapy consults will not be allowed as part of usual inpatient care.
The rationale is to evaluate the differential impact of the one-on-one interaction with a music therapist compared to simple exposure to the music itself.
Standard of care (SoC) arm:
The SoC arm will receive the usual standard of care until discharge or Day 15 of hospitalization. During this time, routine orders for music therapy consults will not be allowed as part of usual inpatient care.
- Conditions
- Parkinson Disease, Dementia, Lewy Body, Delirium
- Being tested
- Music therapy intervention, Standard Care (in control arm)
- Keywords
- music therapy, music based intervention
- Medical subject headings
- Parkinson Disease, Lewy Body Disease, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapy interventionBehavioural
Music therapy intervention administered for 30 minutes 3x/week by certified music therapist.
Standard Care (in control arm)Other
placebo arm, routine standard care
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy | Experimental | Music therapy intervention will be administered for 30 minutes 3 times per week between Day 0 and Day 15 of inpatient hospitalization. Daily passive music listening will be required for 30 minutes twice a day, at least 4 days per week. This daily listening experience will consist of personalized playlists developed by the music therapist with specific purpose and goal. Receives: Behavioral: Music therapy intervention |
| Standard care | Placebo comparator | Usual standard care. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confusion Assessment Measure (CAM)
A brief screening tool to assess for presence or absence of delirium
Measured: administered at enrollment and once every 24 hours during study period
Secondary outcomes (1)
Medication Administration Records and Orders
We will measure recorded use and dosage of medications used to treat delirium. We will collect data on use of physical restraints and one-to-one sitters.
Measured: From enrollment up to 30 days after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Apr 2024
- Primary completion1 Jul 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kara Smith, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063161
- Sponsor's protocol ID
- H00001398
- Status last verified
- Nov 2025
- First submitted
- 26 Sep 2023
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will be considered case by case by study team
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy for Hospitalized Patients With Parkinson's Disease and Lewy Body Dementia: A Randomized Controlled Pilot Trial to Prevent Delirium
- ClinicalTrials.gov ID
- NCT06063161
- Acronym / sponsor ID
- H00001398
- Conditions
- Parkinson Disease, Dementia, Lewy Body, Delirium
- Keywords
- music therapy, music based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 2 Oct 2023 (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 goal of this clinical trial is to test whether a music therapy intervention (MT) prevents hospital-acquired delirium (HaD) in patients with Parkinson's disease (PD) and Dementia with Lewy Bodies (DLB). Delirium is defined as a mental state in which you are confused, disoriented, and not able to think or remember clearly. It can start suddenly and is usually temporary. It is common among patients with PD/DLB during hospitalization.
We are conducting a randomized controlled feasibility pilot study of music therapy (MT) in patients with PD/DLB in the inpatient acute hospital setting.
We are testing if receiving music therapy lowers the risk of delirium, compared to other interventions. We are also testing if music therapy lowers the need for certain restraints and medications during the hospitalization.
Participants admitted to UMass Memorial Medical Center will be invited to participate. Participants will be asked to undergo a music therapy intervention for 30 minutes 3 times per week, and to listen to personalized music playlists for 60 minutes 4 times per week. Participants will be assessed for HaD every 24 hours, and will undergo additional surveys and questionnaires.
Researchers will compare the music therapy intervention to two another comparison groups: one group assigned to listen to music on their own, and one group assigned to receive only standard treatments. About one-third of the participants will be assigned to each of the three study groups.
Detailed description
Participants will be screened within 24 hours of inpatient admission to UMass Memorial Medical Center, University Campus (Worcester, MA).
Participants will be randomized equally to one of three groups: 1) Music therapy (MT), 2) Active Control, 3) Standard of Care.
Participants will receive the assigned intervention within 48 hours of admission, and this will continue up to the day of discharge. If a participant remains hospitalized for more than 15 days, the assigned intervention will stop at Day 15.
The study groups are described below:
MT arm:
Participants will undergo one-on-one music therapy sessions of approximately 30 minutes duration, beginning within 48 hours of admission. Sessions will occur 3 times/week. Sessions will be conducted by a board-certified music therapist. Sessions will be customized to address patient needs but will consistently adhere to the four principal MT methods of re-creation, composition, improvisation, and therapeutic listening experiences. Sessions will be responsive to patient preferences, culture, and identity.
A research assistant will supervise and document details of each session on a validated intervention log, for instance time spent on each MT method, type of music utilized, and whether family was involved.
Participants will also receive a music "booster" of daily playlist listening. Developed by the music therapist, two 30-minute personalized playlists will be created taking into consideration the individual's preferences and level of function and cognition. One playlist will be developed to up-regulate alertness to improve orientation and participation in therapies and interventions, and a second playlist will be designed to down-regulate for relaxation/sleep and decreasing agitation. Playlists will be played for 30 minutes each daily (60 minutes total/day) using an iPad and either a speaker or noise cancelling headphones (depending on patient preference and music therapist recommendations) provided by the study team.
At study completion (date of discharge or Day 15 of hospitalization) +/- 2 days we will conduct semi-structured interviews with participants who received MT, and/or healthcare proxy/LAR, to understand perceptions of the MT program.
Active Control arm:
Those assigned to the active control arm will listen to music playlists for 30 min twice a day (1 hr total/day) 3x/week. Playlists will be generated automatically based on popular genres and not personalized. Participants will listen on an iPad using either a speaker or noise cancelling headphones (depending on patient preference and music therapist recommendations).Listening sessions will continue up to Day 15 of admission or until patient is discharged. During this time, routine orders for music therapy consults will not be allowed as part of usual inpatient care.
The rationale is to evaluate the differential impact of the one-on-one interaction with a music therapist compared to simple exposure to the music itself.
Standard of care (SoC) arm:
The SoC arm will receive the usual standard of care until discharge or Day 15 of hospitalization. During this time, routine orders for music therapy consults will not be allowed as part of usual inpatient care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Behavioral: Music therapy interventionMusic therapy intervention will be administered for 30 minutes 3 times per week between Day 0 and Day 15 of inpatient hospitalization. Daily passive music listening will be required for 30 minutes twice a day, at least 4 days per week. This daily listening experience will consist of personalized playlists developed by the music therapist with specific purpose and goal. |
| Standard care | Placebo comparator | Other: Standard Care (in control arm)Usual standard care. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted as inpatient to UMass Memorial Medical Center University Campus
- Diagnosis of PD or DLB (ICD-10 G20 and G31.83 respectively) on active problem list or past medical history OR carbidopa/levodopa on active medication list or ordered in admission orders.
Key exclusion criteria (8 listed)
- Severe hearing loss (unable to perceive sound < 71dB)
- Professed dislike or lack of reward with experiencing of all types of music (Barcelona Music Reward Questionnaire total score <40)
- History of musicogenic seizures
- Delirium present at initial assessment, as determined by a positive Confusion Assessment Method (CAM)
- Admitted to observation status or to Clinical Decision Unit (as these patients would not be expected to remain inpatient long enough to undergo the MT intervention)
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 therapy interventionMusic therapy intervention administered for 30 minutes 3x/week by certified music therapist. | Behavioural | Music Therapy |
| Standard Care (in control arm)placebo arm, routine standard care | Other | Standard care |
Primary outcome
Confusion Assessment Measure (CAM)
Time frame: administered at enrollment and once every 24 hours during study period
A brief screening tool to assess for presence or absence of delirium
1 secondary outcome
Medication Administration Records and Orders
Time frame: From enrollment up to 30 days after enrollment.
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 13 Nov 2025.
- Individual participant dataSharing planned: Undecided. will be considered case by case by study team
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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 therapy intervention in people with Parkinson Disease and Dementia, Lewy Body, run by University of Massachusetts, Worcester 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 2 inclusion and 8 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 13 Nov 2025. 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. Some participants in this study may receive a placebo. 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?
Confusion Assessment Measure (CAM) (time frame: administered at enrollment and once every 24 hours during study period). 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 13 Nov 2025.