Music Therapy as a Treatment for Delirium in Acutely Hospitalized Older Patients

Delirium in Old Age Clinical Trial

Official title:

Music Therapy as a Treatment for Delirium in Acutely Hospitalized Older Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05398211
• Other study ID #: REK 457017
• Status: Completed
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: April 2024
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Confusion
• Delirium
• Delirium Confusional State
• Delirium in Old Age
• Delirium of Mixed Origin
• Delirium Superimposed on Dementia

Intervention

Behavioral:
• Preferred Recorded Music (PRM)
Preferred Recorded Music (PRM) involves a credentialed music therapist in planning and administering, which qualifies it as music therapy, which is defined as a professional use of music and its elements to improve physical, social, communicative, emotional, intellectual, and spiritual health, optimize quality of life and wellbeing(Aigen, 2013; Bruscia, 2014). PRM intervention will be delivered for 30 minutes, once per day at the same time of the day, for three consecutive days. The intervention will consist of the previously assessed preferred songs/musical pieces. During the PRM intervention the MT will start/stop the music and otherwise not engage with the participants during the listening session.
• Preferred Live Music (PLM)
Preferred Live Music (PLM) involves a credentialed music therapist in planning and administering which qualifies it as music therapy, which is defined as professional use of music and its elements to improve physical, social, communicative, emotional, intellectual and spiritual health, optimize quality of life and wellbeing (Aigen, 2013; Bruscia, 2014).PRM intervention will be delivered for 30 minutes, once per day at the same time of the day, for three consecutive days. The intervention will consist of the previously assessed preferred songs/musical pieces. The MT will be more actively engaged in a musical interaction with the participants in the PLM interventions.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Academy of Music, University of Melbourne

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	How many participants were recruited and randomized per month on average from those eligible, calculated by dividing the total number of the participants recruited by the total number of months that the trial recruited for.	Up to 52 weeks
Primary	Retention and attrition rates	Retention is defined as trial completion on study intervention, and will be calculated by dividing the number of participants completing the study by the total number of participants recruited. Attrition rates will be estimated by the percentage of participants that withdrew from the study, and calculated by dividing the number of the participants who withdrew by the total number recruited.	Up to 52 weeks
Primary	Adherence and deviations rates	Adherence to the study protocol is defined as compliance with the described study protocol, and protocol deviations as any change or divergence from the study protocol for each participant. Adherence rate will be estimated by calculating the percentage of the music sessions (interventions) actually completed from those described in the protocol (by dividing the number of completed sessions by the number of planned sessions), and deviation rates will be measured by counting the deviations per participant during their participation in the study.	Up to 52 weeks
Primary	Treatment fidelity rating and internal and external validity of the study	The level of treatment fidelity will be determined using NIH Behavioral Change Consortium questionnaire which assesses 5 mutually exclusive categories: study design, training, delivery, receipt, and enactment. The tool lists 25 fidelity attributes that should be rated dichotomously as:" Present", "Absent but should be present", or "Not applicable".	Up to 52 weeks
Secondary	Delirium severity	Delirium severity as assessed by Observational Scale of Level of Arousal (OSLA), Richmond Agitation Sedation Scale (RASS).	Up to 7 days
Secondary	Cognitive status	Pre-post interventions changes in attention, orientation and short-term memory, assessed by backwards tests and digit span tests, recall tasks and orientation questions from Memorial Delirium Assessment Scale-MDAS)	Up to 7 days.
Secondary	Duration of delirium during hospital stay	As diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria	Up to 3 weeks.
Secondary	Use of "rescue medication" during hospital stay	The total number of psycho-pharmacological medications per patients will be registered.	Up to 3 weeks.
Secondary	Length of hospital stay	The total number of days from admittance to the Acute Geriatric Department to discharge from hospital.	Up to 3 weeks.