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

NCT ID: NCT05398211

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2023-05-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Preferred Recorded Music (PRM)

The Preferred Live Music (PLM) aims to elicit participants' responses from live music and the ensuing musical and non-musical interactions with the music therapist (MT). In the PLM intervention, preferred songs performed live on guitar or electronic keyboard will be played by a credentialed MT. When appropriate participants may also play percussion instruments offered to them. Elements of improvisation will be incorporated to allow for active engagement by the participants, and to provide opportunities for musical and non-musical attunement to emerge.

Group Type: EXPERIMENTAL

Preferred Recorded Music (PRM)

Intervention Type: BEHAVIORAL

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)

The Preferred Recorded Music (PRM) intervention aims to detect responses directly attributable to the music. Participants listen to pre-recorded preferred originally-published versions of music accessed by Spotify music-streaming service and played through loud-speakers. The MT will only start the music, and otherwise not be present during the interventions to ensure the minimal direct interaction with the participants.

Group Type: EXPERIMENTAL

Preferred Live Music (PLM)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian Academy of Music

OTHER

Sponsor Role: collaborator

University of Melbourne

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bjørn Erik Neerland, MD

Principal Investigator, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oslo University Hospital

Oslo, , Norway

Countries

Norway

References

Golubovic J, Neerland BE, Simpson MR, Johansson K, Baker FA. A randomized pilot and feasibility trial of live and recorded music interventions for management of delirium symptoms in acute geriatric patients. BMC Geriatr. 2025 May 2;25(1):306. doi: 10.1186/s12877-025-05954-1.

Reference Type: DERIVED

PMID: 40316916 (View on PubMed)

Other Identifiers

REK 457017

Identifier Type: -

Identifier Source: org_study_id