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

NCT05398211 | Completed

• 1 other identifier: REK 457017
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• Delirium severity

  Up to 7 days

• Cognitive status

  Up to 7 days.

• Duration of delirium during hospital stay

  Up to 3 weeks.

• Use of "rescue medication" during hospital stay

  Up to 3 weeks.

• Length of hospital stay

  Up to 3 weeks.

Study Arms (2)

Preferred Recorded Music (PRM)

EXPERIMENTAL

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.

Behavioral: Preferred Recorded Music (PRM)

Preferred Live Music (PLM)

EXPERIMENTAL

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.

Behavioral: Preferred Live Music (PLM)

Interventions

Preferred Recorded Music (PRM) 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 Recorded Music (PRM)

Preferred Live Music (PLM) 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.

Preferred Live Music (PLM)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian Academy of Music: collaborator
• University of Melbourne: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, N-0424, Norway

Location

Related Publications (1)

• 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.

  PMID: 40316916 DERIVED

MeSH Terms

Conditions

Delirium; Confusion

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking of the therapist and the participants will not be possible, due to the nature of the interventions. Additionally, the music therapist will need to be acquainted with the results of the randomization in order to tailor each individual intervention. Masking of the outcome assessors will be attempted, but is expected to be incomplete, since the assessors will have to related to both the patients directly and to the medical staff who are well-acquainted with the patients, and who both might accidentally reveal the treatment allocation. Outcome assessors will attempt to remind the medical staff to keep the allocation concealed at all times. In order to verify the masking, the assessors will be asked about their knowledge of the patients' allocation to the treatment groups upon the last completed assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Model Details: A randomized controlled repeated measures design.

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 31, 2022
• Study Start: June 15, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

NO (1)