Delirium in Old AgeNCT05398211
Music Therapy as a Treatment for Delirium in Acutely Hospitalized Older Patients
A study testing Preferred Recorded Music (PRM) and Preferred Live Music (PLM) in people with Delirium in Old Age and Delirium of Mixed Origin, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium in Old Age, Delirium of Mixed Origin, Delirium Superimposed on Dementia
- What is being tested?
- Preferred Recorded Music (PRM) and Preferred Live Music (PLM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNorway
- Study dates
- 15 Jun 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Preferred Recorded Music (PRM), Preferred Live Music (PLM)
- Keywords
- music interventions, music therapy, delirium, acute confusion, treatment, severity, acute geriatrics, arousal, attention, cognition
- Medical subject headings
- Delirium, Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preferred Recorded Music (PRM)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Preferred Live Music (PLM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: Up to 52 weeks
Secondary outcomes (5)
Delirium severity
Delirium severity as assessed by Observational Scale of Level of Arousal (OSLA), Richmond Agitation Sedation Scale (RASS).
Measured: Up to 7 days
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)
Measured: Up to 7 days.
Duration of delirium during hospital stay
As diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria
Measured: Up to 3 weeks.
Use of "rescue medication" during hospital stay
The total number of psycho-pharmacological medications per patients will be registered.
Measured: Up to 3 weeks.
Length of hospital stay
The total number of days from admittance to the Acute Geriatric Department to discharge from hospital.
Measured: Up to 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start15 Jun 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled repeated measures design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Academy of Music, University of Melbourne
- Responsible party
- Principal investigator, Bjørn Erik Neerland, MD, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398211
- Sponsor's protocol ID
- REK 457017
- Status last verified
- Apr 2024
- First submitted
- 13 May 2022
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40316916
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy as a Treatment for Delirium in Acutely Hospitalized Older Patients
- ClinicalTrials.gov ID
- NCT05398211
- Acronym / sponsor ID
- REK 457017
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Academy of Music, University of Melbourne
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled repeated measures design.
| Arm | Type | Receives |
|---|---|---|
| Preferred Recorded Music (PRM) | Experimental | Behavioral: 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. |
| Preferred Live Music (PLM) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Preferred Recorded Music (PRM) |
| 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. | Behavioural | Preferred Live Music (PLM) |
Primary outcome
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.
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.
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.
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".
5 secondary outcomes
Delirium severity
Time frame: Up to 7 days
Cognitive status
Time frame: Up to 7 days.
Duration of delirium during hospital stay
Time frame: Up to 3 weeks.
Use of "rescue medication" during hospital stay
Time frame: Up to 3 weeks.
Length of hospital stay
Time frame: Up to 3 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 40316916Golubovic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preferred Recorded Music (PRM) and Preferred Live Music (PLM) in people with Delirium in Old Age and Delirium of Mixed Origin, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Up to 52 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05398211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.