Clinical trial NCT05398211: Music Therapy as a Treatment for Delirium in Acutely Hospitalized Older Patients
Official title: Music Therapy as a Treatment for Delirium in Acutely Hospitalized Older Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium in Old Age
Delirium of Mixed Origin
Delirium Superimposed on Dementia
Delirium Confusional State
Keywords: music interventions
music therapy
delirium
acute confusion
treatment
severity
acute geriatrics
arousal
attention
cognition
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Academy of Music
name: University of Melbourne
First posted: 2022-05-31
Enrollment: 26
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled repeated measures design.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess feasibility and potential effectiveness of two different music interventions for managing delirium symptoms in acute geriatric patients.

Detailed description: Delirium is a neuropsychiatric syndrome characterized by an acute alteration in attention, awareness, arousal and cognition, precipitated by an acute illness, intoxication, trauma or surgery. It is highly prevalent in older, frail and acutely hospitalized patients, and associated with poor outcomes, with few effective treatment alternatives. Non-pharmacological interventions and music show promising effects.

This study protocol aims to determine whether music interventions (MIs) delivered by a credentialed music therapist, are feasible and effective for regulating delirium symptoms in acute geriatric patients and whether the standardized delirium tools are sensitive to detect observable responses. Primary, feasibility outcomes are evaluating recruitment rate, treatment fidelity and adherence, as well as feasibility and accuracy in data collection procedures. Main effect-outcome is delirium severity, but delirium duration, cognitive status, length of hospital stay, and medication use will also be recorded. The randomised repeated measures controlled trial design will record the participant responses before and after exposure to MIs (+/- 2 hours). Participants with delirium from an acute geriatric ward will be randomized to either live or recorded MI. Each intervention will be delivered to n=30 participants (n=60 in total), for 30 minutes, over three consecutive days. Ethical approval has been obtained from Regional Ethics Committee South East Norway.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 65 and with delirium or possible delirium at admission or detected within the last 72 hours, and still present.
* Appropriate informed consent is obtained.
* Participants will not be excluded if they are under long term care and have comorbidities such as dementia or mild cognitive impairment.
* Patients will not be excluded if they have Covid-19.

Exclusion Criteria:

* Patients who were previously enrolled, and were readmitted during the study period will not be re-included.
* The patients with severe hearing impairments, severe psychiatric conditions, and/or severe alcohol/substance addiction where that is the main reason for admission will be excluded.
* The patients whose assessed musical preferences involve orchestral or other kinds of music which cannot be performed live by voice and a guitar.

Primary outcomes:
measure: Recruitment rate
timeFrame: Up to 52 weeks
measure: Retention and attrition rates
timeFrame: Up to 52 weeks
measure: Adherence and deviations rates
timeFrame: Up to 52 weeks
measure: Treatment fidelity rating and internal and external validity of the study
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Delirium severity
timeFrame: Up to 7 days
measure: Cognitive status
timeFrame: Up to 7 days.
measure: Duration of delirium during hospital stay
timeFrame: Up to 3 weeks.
measure: Use of "rescue medication" during hospital stay
timeFrame: Up to 3 weeks.
measure: Length of hospital stay
timeFrame: Up to 3 weeks.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References: