Recruiting

Music Therapy

Sponsor:

Boston Medical Center

Code:

NCT07137949

Conditions

Delirium

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Music therapy

Study Details

Brief summary:

In this pilot study a new kind of music therapy will be created and tested to help prevent confusion, called delirium, that can happen in the hospital. This can affect people with brain diseases like Alzheimer's disease and Parkinson's disease.

Each of the anticipated 30 participants will have up to five music therapy sessions. The sessions will be made just for them and may include live music, playing instruments, or listening to recorded music. Surveys will be used to learn how easy the therapy is to do in the hospital and what people think about how helpful the sessions may be for future patients.

Conditions

Delirium

Study ID

NCT07137949

Start date

Mar 11, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Admitted as inpatient to Boston Medical Center.
  • Cognitive impairment or neurodegenerative diseases as defined by either:

  • Diagnosis of Parkinson's Disease, Dementia with Lewy Bodies (ICD-10 G20 and G31.83 respectively), Alzheimer's Disease-related dementias (ICD-10 6D80), vascular dementia (F01), or other cognitive impairment (R41) on active problem list or past medical history
  • "Cognitive impairment" on active problem list or past medical history
  • Documentation elsewhere in the electronic medical record (e.g. notes) of any of these conditions
  • Participants with cognitive impairment will be included. If unable to consent, legally authorized representative (LAR) based on HRP-013-SOP-LARs, Children, and Guardians will be contacted to consent.
  • Spanish speaking participants will be included. Screening and informed consent procedures will be conducted using a certified medical interpreter. All intervention sessions and study team interactions will be conducted using these interpreter services.
  • Patients admitted to an intensive care unit will be included as long as they are not receiving continuous intravenous sedative medications. Potential participants in the intensive care unit setting will be discussed with a PI/co-I to ensure participation is appropriate on a case-by-case basis. The PI/Co-I will confirm with the treating physician that there are no reasons as to why the potential participant should not be enrolled in the study.

Exclusion Criteria:

  • Admitted to observation status (as these patients would not be expected to remain inpatient long enough to undergo the MT intervention)
  • Patients who will be discharged within 24 hours of eligibility based on discussion with primary admitting team
  • Self-reported history of musicogenic seizures
  • Hearing loss: unable to hear a recorded sound <70 decibels (dB)
  • Dislike of music: Barcelona Music Reward Questionnaire score of <40
  • Patients who are currently prisoners
  • Patients in the intensive care unit receiving continuous intravenous sedative medication
  • Pregnant women

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Music therapy

Participants will undergo one-on-one music therapy (MT) sessions of approximately 30 minutes duration 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.

Interventions

Music therapy

Live music therapy (MT) sessions will occur 3 times/week, up to 5 sessions. Sessions will be responsive to patient preferences, culture, and identity using information gained from medical record review, intake assessment, and in the moment therapeutic assessments.

Primary outcome measure

  • Delirium scores [ Time Frame: every 24 hours until discharge (on average 7 days) ]
  • Number of music therapy sessions successfully completed [ Time Frame: during hospitalization, on average 7 days ]

Central Contacts and Locations

Central contacts

Kara M Smith, MD MSCI FAAN

617-638-5351kara.smith@bmc.org

Amber Payne, MS

amber.payne@bmc.org

Locations

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Kara M Smith, MD MSCI FAAN

kara.smith@bmc.org

More Information

Sponsor

Boston Medical Center

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • Music therapy
  • Hospital acquired delirium
  • Neurodegenerative disease patients

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Medical Center on 2026-04-01.