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Completed

NCT Number: NCT05398211

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

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.

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Key information

Conditions

Delirium in Old Age Confusion Delirium Delirium Confusional State Delirium Superimposed on Dementia Delirium of Mixed Origin Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, N-0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. Recruitment rate

    Time frame: Up to 52 weeks

    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.

  2. Retention and attrition rates

    Time frame: Up to 52 weeks

    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.

  3. Adherence and deviations rates

    Time frame: Up to 52 weeks

    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.

  4. Treatment fidelity rating and internal and external validity of the study

    Time frame: Up to 52 weeks

    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".

Secondary outcomes

  1. Delirium severity

    Time frame: Up to 7 days

    Delirium severity as assessed by Observational Scale of Level of Arousal (OSLA), Richmond Agitation Sedation Scale (RASS).

  2. Cognitive status

    Time frame: Up to 7 days.

    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)

  3. Duration of delirium during hospital stay

    Time frame: Up to 3 weeks.

    As diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria

  4. Use of "rescue medication" during hospital stay

    Time frame: Up to 3 weeks.

    The total number of psycho-pharmacological medications per patients will be registered.

  5. Length of hospital stay

    Time frame: Up to 3 weeks.

    The total number of days from admittance to the Acute Geriatric Department to discharge from hospital.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian Academy of Music
  • University of Melbourne

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 31, 2022
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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