NCT06063161Completed
Music Therapy to Prevent Hospital-acquired Delirium in Parkinson's Disease and Dementia With Lewy Bodies
Music Therapy for Hospitalized Patients With Parkinson's Disease and Lewy Body Dementia: A Randomized Controlled Pilot Trial to Prevent Delirium
Source: ClinicalTrials.gov · Last updated 13 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 26 Sept 2023
- Start date
- 1 Apr 2024
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- University of Massachusetts, Worcester
- Diseases
- Lewy body dementia, Parkinson disease
- NCT number
- NCT06063161
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 1 Apr 2024 to the primary completion date, 1 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- History of musicogenic seizures
Other
- 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)
- 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.
Who the study is looking for
- 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.
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UMass Medical School/UMass Memorial Medical Center Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.