Music Therapy to Prevent Hospital-acquired Delirium in Parkinson's Disease and Dementia With Lewy Bodies

NCT06063161 | Completed

• 1 other identifier: H00001398
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Parkinson Disease; Dementia, Lewy Body; Delirium

Keywords

music therapy; music based intervention

Outcome Measures

Primary Outcomes (1)

• Confusion Assessment Measure (CAM)

  A brief screening tool to assess for presence or absence of delirium

  administered at enrollment and once every 24 hours during study period

Secondary Outcomes (1)

• Medication Administration Records and Orders

  From enrollment up to 30 days after enrollment.

Study Arms (2)

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.

Behavioral: Music therapy intervention

Standard care

PLACEBO COMPARATOR

Usual standard care.

Other: Standard Care (in control arm)

Interventions

Music therapy intervention BEHAVIORAL

Music therapy intervention administered for 30 minutes 3x/week by certified music therapist.

Music Therapy

Standard Care (in control arm) OTHER

placebo arm, routine standard care

Standard care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMass Medical School/UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Lewy Body Disease; Delirium

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Neurocognitive Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded study coordinator will assess the primary outcome (Confusion Assessment Measure) to reduce bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 2, 2023
• Study Start: April 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-11

Locations

US (1)