A Randomized Pilot and Feasibility Trial of Live and Recorded Music Interventions for Management of Delirium Symptoms in Acute Geriatric Patients

doi:10.21203/rs.3.rs-4186287/v1

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Research Article

A Randomized Pilot and Feasibility Trial of Live and Recorded Music Interventions for Management of Delirium Symptoms in Acute Geriatric Patients

https://doi.org/10.21203/rs.3.rs-4186287/v1

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Background

Delirium is an acute shift in attention and arousal, usually triggered by acute illness or surgery in older dementia patients. Prognosis is poor, and pharmacological options are limited; non-pharmacological interventions and music show promise.

Methods

This randomised pilot and feasibility trial tested feasibility, acceptability, fidelity, and safety of music interventions (MIs) for delirium patients and assessed preliminary effectiveness and suitability of the selected effect outcomes. Participants from an acute geriatric ward were randomised to Preferred Recorded Music (PRM) and Preferred Live Music (PLM), delivered for 30 minutes over three consecutive days. Feasibility outcomes included recruitment rate, retention, adherence, deviations, and treatment fidelity. Clinical outcomes were trajectory of delirium symptoms (arousal, attention, cognition), delirium duration, hospital stay length, and medication intake. Post-intervention and between groups changes in delirium symptoms were compared using mixed linear regression models for the repeated measurements. Mann-Whitney test and Fishers exact test were used for length of stay and medication use, respectively.

Results

26 participants (PLM = 14; PRM = 12), median age 87, most with hypoactive delirium were recruited at a rate of 3 participants per month. Retention rates for PLM and PRM were 64% and 33% respectively, and adherence to PLM and PRM intervention protocols were 83% and 58%, respectively. Total adherence to the assessment protocols was 44%. PLM was delivered as intended, (treatment fidelity 93%), and PRM did not satisfy treatment fidelity (83%). All delirium symptoms except arousal improved on day 3 compared to baseline, with statistically significant improvement in attention. No conclusive pre-post or between-group differences were detected for any outcomes; confidence intervals were wide.

Conclusions

Feasibility of recruitment, interventions and assessments was indicated, and greater acceptability, safety and fidelity of the PLM intervention compared with the PRM. Adoption of external assessors is warranted in future trials, to mitigate slow recruitment and low adherence. Wide confidence intervals for most measures and comparisons indicate that the possible effect of the MIs on delirium cannot be excluded. The trial was registered at Clinical Trials, ID: NCT05398211, on 31/05/2022.

feasibility

delirium

music

music therapy

severity

Covid-1

Delirium is a clinical syndrome represented by an acute change in mental status (1) and inattention; cognitive dysfunction, disturbed level of arousal, psychotic episodes, emotional and behavioural changes may also be present (1, 2). Delirium is common in hospital settings, occurring in > 50% of patients (3), with the highest prevalence in older, frail (4–6), acutely hospitalized, and mechanically ventilated patients in postsurgical intensive care units (ICUs) (7–9). Delirium develops suddenly, is transient with fluctuating symptoms (7). Pathophysiology is complex and not completely understood, involving an interplay between the predisposing factors such as advanced age, underlying illness like dementia, and precipitating factors such as acute illness, drugs, or surgery (7). Delirium is strongly correlated with Covid-19 (10, 11), and is likely to cause complications in older adults (12).

Delirium is often undetected, misdiagnosed, or confounded with other conditions, sharing symptoms with dementia, depression or psychosis (13). Prognoses is poor, including prolonged hospitalization (14), need for long term care (15, 16), onset or worsening of cognitive impairment (7, 14), and increased mortality risk (7, 17). Benzodiazepines and antipsychotic medication are ineffective in treating delirium and may have adverse side-effects (18, 19). Non-pharmacological, multicomponent approaches might address multifactorial delirium etiology, and are showing promising effects in preventing delirium (3, 17), decreasing agitation (8, 20), and deriving interest, pleasure and general well-being (21). The evidence of their effectiveness in clinical management of delirium symptoms is still scarce (20, 22).

Music interventions (MIs) have positive effects on behavioural and psychological symptoms of conditions similar to delirium, such as dementia (23–30) and disorders of consciousness (31, 32), and may also be effective in prevention and treatment of delirium in older individuals. Our systematic review (33) showed that research on MIs for delirium is scarce; existing trials show promising results, particularly for delirium prevention. High patient acceptability and enjoyment of MIs, cost-effectiveness, and absence of adverse effects were also commonly reported (33). Despite the moderate-high risk of bias among the included studies, our meta-analysis indicated that postsurgical, critically ill, and mechanically ventilated patients were 50% less likely to develop delirium after being exposed to music postoperatively (33). Significant improvements in engagement, mood, and delirium severity were also found in acute geriatric and long-term care patients post-intervention (34–36). However, better designed trials, with standardized interventions, in specific clinical settings and utilizing outcome measures able to capture clinically meaningful changes, are still needed to substantiate existing effectiveness claims. The aim of the current trial was to pilot test and establish feasibility to determine the need for investing in a future randomised controlled trial (RCT) design. The objectives of this study were to establish: (1) the feasibility of recruitment procedures and establish the likely recruitment rate; (2) the feasibility of assessments and follow-up procedures; (3) the success of and fidelity adherence of interventions implemented by the therapist; (4) the interventions’ acceptability; (5) the safety of the interventions; and (6) the sensitivity and suitability of the selected effect-outcomes to assess the efficacy of the music interventions. Clinical objectives were: (1) to estimate preliminary efficacy of live and recorded MIs on severity of delirium symptoms, and (2) to establish preliminary evidence of the specific delirium symptom domains most responsive to the MIs.

Trial design

We adopted a two-arm randomized repeated measures design to evaluate the feasibility and preliminary effectiveness of Preferred Recorded Music (PRM), and Preferred Live Music (PLM) interventions. Participants received the interventions once a day, for three consecutive days. The main clinical outcomes were assessed at baseline, one-hour pre-intervention, one-hour post intervention each day, and at discharge. Our study protocol detailing the intervention description, theoretical rationale, and statistical analysis plan, was published prior to the completion of data-collection (37). This trial is reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) statement’s extended checklist for pilot and feasibility trials (Additional file 8)(38). The trial was registered at Clinical Trials (NCT05398211) on 31/05/2022.

Participants

Participants were recruited from an acute geriatric ward within the Division of Geriatric Medicine at Oslo University Hospital (OUH), where the prevalence of dementia and delirium is high. The 20 bed ward admits 75–80 older patients per month (≥ 65 years) for acute medical care (39). After delirium screening at admission, using 4AT(40) - a rapid validated tool for delirium detection - patients with the score ≥ 4 were assessed by geriatricians for eligibility. Delirium was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria (1) applying a recommended diagnostic test battery, previously described in our protocol (2, 37, 41–44) (Additional file 2). Subtypes were determined using the well validated Delirium Motor Subtyping Scale (DMSS-4)(45) .

Patients were eligible if:

(1) aged ≥ 65 years

(2) diagnosed with delirium or subsyndromal delirium within the last 72 hours and still present

(3) informed consent was obtained.

Patients with comorbidities such as dementia, mild cognitive impairment, or those under long-term care were also included, and we did not exclude patients with COVID-19. Patients were excluded if:

Previously enrolled in the study and were readmitted to the ward during the study period

Presenting with severe hearing impairments

Presenting with severe psychiatric conditions other than delirium

Admitted due to severe alcohol or substance addiction

Their assessed musical preferences included orchestral or other kinds of music impossible to perform live by voice and accompaniment

The 5th criteria was included after the trial commenced, registered at Clinical Trials on the 5th of December, 2022, and included in the published protocol (37).

Randomization and Masking

Eligible, consenting patients were randomized to study arms using permuted block randomization 1:1, and the online randomization software, True Random Numbers (https://www.random.org/). An independent researcher generated randomization blocks of 10 participants, to maintain even number in the two study-arms. The participants were assigned to their respective interventions by the music therapist, after baseline delirium assessments and before assessments of music preferences.

The therapist and the participants could not be masked to group allocation due to the nature of the interventions; assessors were masked. To increase the success of masking of assessors, staff at the ward were instructed not to reveal what treatment arm participants were assigned to, and the music therapist walked into the participants’ rooms with her guitar and the loud-speaker, regardless of assigned intervention.

Interventions and comparators

Two interventions tested in this study, 1) Preferred Recorded Music (PRM) and 2) Preferred Live Music (PLM), were delivered by a certified music therapist (MT). PLM was delivered by voice and a guitar and included improvisation elements and active engagement of the MT. The PRM was delivered via a loudspeaker; the MT was instructed to refrain from engaging therapeutically with the patient. The potential therapeutic efficacy of preferred music, underlying both interventions, stems from its personal, social and cultural attributes, allowing it to alter emotional responses (46), boost self-awareness (47), and transiently enhance certain cognitive functions like autobiographical memory (48). The live music component and responsive musical and non-musical interactions with the MT in the PLM intervention were expected to regulate arousal levels and attention. Synthetic, loudspeaker sound and original versions of the preferred music in PRM intervention were expected to stimulate autobiographic memory and moderate attention and arousal. A more detailed description of the interventions and the theoretical rationale is provided in our published protocol (37).

After the baseline assessments, the MT assessed participants’ music preferences from legal guardians, using an adapted Norwegian version of the Assessment of Personal Music Preference tool (APMP) (48), and after that, directly from the participants in an interactive, 30 minutes’ session, using a Music Assessment Tool (MAT) (49). Music for the interventions was selected by the MT using the acquired information. The participants received their allocated interventions for 30 minutes (between 8 AM and 5 PM) over three consecutive days, in addition to usual care. Participants were considered to have adhered to the intervention protocol if they completed at least 10 minutes of the sessions. MIs were primarily delivered in the participants’ private rooms, except when they shared a room with another patient.

Outcomes

Our published protocol previously described outcomes relevant to our feasibility and clinical objectives and the detailed assessment schedule (37). The main properties of the assessment tools are provided in Additional files 1–3.

Feasibility outcomes were assessed during and upon the completion of the intervention period and comprised:

(1) Recruitment rate: an average number of patients recruited per month.

(2) Retention rate: the proportion of participants completing the study as described in the protocol. Withdrawals were defined as withdrawing consent to participate in the study. Dropouts were defined as any discontinuations of the interventions and assessments due to the participants’ health condition, discharge, or an unavailable assessor. Refusals were defined as the patient declining invitations to be involved in assessment or treatment.

(3) The proportion of sessions where the MIs and pre-post assessments were completed as planned (adherence to study protocol) and the proportion of sessions with protocol deviations. Deviations were categorized as patient or interventionist-related and further classified as minor, major, or fatal based on their impact on data quality and patient safety, with the fatal category indicating patients’ death (49).

(4) The success of treatment fidelity (TF) was determined by observing the video recordings of 20% of randomly selected participants from both intervention groups who had completed the interventions as per protocol. Video recordings were evaluated by an independent rater using a bespoke checklist for each intervention. The six checklist items were scored and calculated (no = 0, yes = 1 point), and the threshold for satisfied treatment fidelity for each participant was ≥ 80% averaged across the three intervention days, including satisfied compulsory items 4–6 for each session. The intervention was considered not to have met fidelity if the compulsory items were not satisfied even if the total score was ≥ 80%.

Secondary clinical outcomes were assessed at baseline, pre- and post-session, and at discharge by the specially trained geriatricians at the ward and included:

(1) Trajectories of delirium symptoms, assessed using DSM-5 diagnostic test-battery (37) comprising: Observational Scale of Level of Arousal (OSLA)(42) and modified Richmond Agitation Sedation Scale (mRASS)(50–52) for level of arousal; backwards tests and digit span tests for attention (41, 44).; orientation and short-term memory, using delayed recall tasks and orientation questions from Memorial Delirium Assessment Scale (MDAS) (53) for orientation and short term memory.

(2) Duration of delirium: determined by an experienced delirium researcher (BEN) after the discharge from the ward, based on all the previously assessed data.

(3) Length of hospital stay (LOS)

(4) Use of Pro Re Nata (PRN), non-prescribed psychopharmacological medication (benzodiazepines and antipsychotics).

LOS and use of psychopharmacological medications during the hospitalization were retrieved from the electronic medical journals at discharge (Additional file 1).

Adverse events were recorded after music and assessment sessions and from daily reports by the medical staff at the ward. The events were categorized as critical and non-critical for the patients’ health and well-being and related or unrelated to the interventions.

Statistical methods

The statistical analysis plan is described in our previously published protocol (37).

Linear mixed models were used to estimate the change in OSLA, mRASS, attention and cognitive status from pre- to post-intervention and from baseline for each assessment day, and for the comparison between the intervention groups. The marginal effects were calculated for each of these comparisons, with adjustments for the participants' baseline scores, and using participants’ ID as a random effect, to incorporate the individual differences into the analysis. The Mann-Whitney test for skewed data was used to calculate the difference between the groups in length of hospital stay. We applied Fisher’s Exact test for small samples to determine group differences in received PRN medication.

Participants flow and recruitment

Potential participants were screened for eligibility between 15th June 2022 and 21st April 2023 (approximately 39 weeks). Of the 809 patients admitted to the acute geriatric ward during the recruitment period, 66 patients were assessed for eligibility (Fig. 1). Of these, 40 were excluded due to uncertain delirium diagnosis, patient receiving end of life care, or being discharged before the sessions could begin, contagion (other than COVID-19), aphasia preventing completion of assessments of delirium, unavailable assessor for the rest of the evaluations, or music therapist unavailability. In total n = 26 patients met all the inclusion criteria and were randomized (PLM, n = 14; PRM, n = 12) (Fig. 1).

Baseline demographic and clinical characteristic were similar across the intervention groups (Table 1). Participants’ median age was 87, half were female (n = 13), and the majority lived alone (n = 19, 73%,), or with others (n = 4, 15%,) in the community. All had DSM-5 delirium at baseline, 68% hypoactive and 20% had no recognizable subtype. In 73% of cases (n = 19), infection, fracture or a cardiovascular event precipitated delirium. For some participants the trigger was unknown, or hard to ascertain due to underlying dementia or depression. Clinical frailty scale scores were obtained for n = 15 participants (58%), showing scores of ≥ 5 in 14 out of 15 tested patients, and a median score of 7. Along with the median frailty index of 0.40 in these participants, this score indicated severe frailty. The median NEWS2 score of 3 at admission to the AG ward indicated low to moderate acute illness severity (Table 1).

Table 1

Demographic and clinical characteristics at baseline
Characteristics	All participants n = 26	PLM n = 14	PRM n = 12
Demographics
Age, median (IQR)	87.0 (80.8–92.3)	87.0 (79.3–92.3)	89.5 (83.3–92.8)
Women, n (%)	13 (50)	7 (50)	6 (50)
Men, n (%)	13 (50)	7 (50)	6 (50)
Place of residence before hospitalization
Private home, with others, n (%)	4 (15.4)	4 (28.6)	0
Private home, alone n (%)	19 (73.1)	10 (71.4)	9 (75.0)
Assisted Living facility, n (%)	2 (7.7)	0	2 (16.7)
Residential care home, n (%)	1 (3.8)	0	1 (8.3)
Level of care
No public services, n (%)	5 (19.2)	2 (14.3)	3 (25.0)
House help/practical assistance, n (%)	1 (3.8)	1 (7.1)	0
Home nursing care, n (%)	16 (61.5)	8 (57.1)	8 (66.7)
Long term residential care, n (%)	2 (7.7)	1 (7.1)	1 (8.3)
Other, n (%)	2 (7.7)	2 (14.3)	0
Medical, at admission
Reasons for hospitalization, n (%)
Fall, fracture, injury, n (%)	12 (46)	3 (21)	9 (75)
Chest pain, shortness of breath, n (%)	4 (15)	1 (7)	3 (25)
Delirium, confusion, somnolence, n (%)	8 (30)	3 (25)	5 (42)
Other, n (%)	9 (35)	9 (64)	0
Clinical Frailty Scale, median (IQR)^a	7.0 (6.0–7.0)	7.0 (5.0–7.0)	6.0 (6.0–7.0)
Frailty index (FI), median (IQR) ^e	0.4 (0.4–0.5)	0.4 (0.3–0.4)	0.4 (0.4–0.5)
Number of prescribed medications, median (IQR)	5.5 (3.0–7.0)	6.0 (3.5–8.3)	5.0 (3.0–6.0)
IQCODE ^b	3.6 (3.3–4.5)	3.4 (3.0–3.4)	3.7 (3.5–3.7)
NEWS II at admission to hospital, median (IQR)^c	3.0 (1.0–6.0)	3.0 (1.0–5.8)	3.5 (0.3–6.8)
NEWS II at admission to the acute geriatric ward	3.0 (1.0–5.0)	2.0 (0.8–5.3)	3.0 (2.3–5.0)
Delirium status at baseline
DSM-5 delirium, n (%)	26 (100)	12 (100)	14 (100)
Digit Span forward, digits correct, median (IQR)	3.0 (0.0–4.3)	3.00 (0.8–4.3)	3.5 (0.0–4.8)
SAVEAHAART/KATAMARAAN, number of mistakes, median (IQR)	2.0 (0.0–10.0)	3.5 (0.8–10.0)	1.0 (0.0–8.0)
Days of the week backwards, numbers correct, median (IQR)	3.0 (0.0–7.0)	1.0 (0.0–6.3)	5.5 (0.0–7.0)
Months of the year backwards, numbers correct, median (IQR)	3.0 (0.0–5.5)	1.5 (0.0–4.3)	4.5 (0.0–7.0)
Count backwards from 20 to 1, numbers correct, median (IQR)	7.0 (0.0–20.0)	2.5 (0.0–15.5)	14.5 (3.5–20.0)
Orientation, number of correct items, median (IQR)	3.0 (0.8–7.0)	2.5 (0.0–4.8)	5.5 (2.3–7.0)
Delayed recall, numbers correct, median (IQR)	0.0 (0.0–0.0)	0.0 (0.0–0.0)	0.0 (0.0–0.8)
OSLA score, median (IQR)	2.5 (1.3–6.8)	2.0 (1.5–8.0)	3.0 (1.0–6.0)
mRASS score, median (IQR)	0.0 (-1.0–0.0)	0.0 (-1.0–0.5)	-0.5 (-1.7–0.0)
Delirium motor subtype, n (%) according to DMSS4 ^d
Hyperactive, n (%)	2 (8)	1 (8)	1 (8)
Hypoactive, n (%)	17 (68)	10 (77)	7 (58)
Mixed, n (%)	1 (4)	1 (8)	0
No subtype, n (%)	5 (20)	1 (8)	4 (33)

PLM Preferred Live Music, PRM Preferred Recorded Music, IQR Inter quartile range, IQCODE Informant Questionnaire on Cognitive Decline in the Elderly, CFS Clinical Frailty Scale, NEWS2 National Early Warning Score II, DSM-5 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, SAVEAHAART/KATAMARAN Vigilance test, OSLA Observational Scale of Level of Arousal, mRASS Modified Richmond Agitation Sedation Scale, DMSS4 Delirium Motor Subtype Scale 4.

^a Clinical frailty scale missing in 11 patients; 4 in PLM group and 7 in PRM group.

^b IQCODE missing in 20 patients; 11 in PLM group and 9 in PRM group

^c NEWS2 missing in 2 patients in PLM group

^d DMSS4 missing in 1 patient in PLM group

^e Frailty Index missing in 3 patients

Feasibility Outcomes

The average recruitment rate was 3 participants per month (Table 2). The retention rates for the participants in PLM and PRM groups were 64% and 33% respectively. Most withdrawals were due to worsening of the participants’ health condition, but none withdrew their consent to use the data collected prior to withdrawal.

The total adherence to the study protocol (both interventions and assessments) was 29% in the PLM (n = 4 patients), and 17% in the PRM group (n = 2 patients). Five additional participants in the PLM group met the per-protocol criteria but were excluded because their assessments occurred outside of the assessment window.

The total number of conducted music sessions, including those with deviations, was 55 out of the planned 78 (PLM = 42; PRM = 36). Common reasons for missing sessions were: 1) minimum dosage of 10 minutes was not met, 2) unavailability of assessor/music therapist to assess/treat, 3) patient became palliative, or 4) patient was discharged. The percentage of adherence to the PLM and PRM protocols were 83% and 58% respectively. Of the 21 completed PRM sessions, 17 were delivered with some deviations (81%), of which the most common were the unwanted interaction between the patient and the therapist, and in some cases changing the order of songs from one intervention day to another. No significant protocol deviations were registered during the PLM, and most sessions were delivered as intended.

The success of TF was 93% for the PLM, including satisfied complementary items 4–6 in the checklists, and 83% for the PRM, with one of the complementary items not satisfied. As planned, music preferences were assessed with input from the legal guardians and participants. Only two participants were not able to contribute to music preference assessments due to their worsened health condition at the time of assessment (Table 2).

Of the planned 78 pre-post delirium assessments in both groups, 34 were successfully completed (44%). Adherence to the assessment procedures in PLM was 62%. Ten pre-post assessment were not completed due to unavailable assessor, patient discharged or becoming palliative: six of the pre-post assessments were out of the assessment window. Adherence to the assessment procedures in PRM was 50%, with 15 pre-post assessments missing due to the unavailable assessor, patient discharged or becoming palliative, and three pre-post assessments were conducted outside of the assessment window.

One serious adverse event (death) occurred during the intervention period but was unrelated to the interventions. Minor, potentially intervention-related events such as patients falling asleep while listening to music, as well as showing signs of boredom and restlessness or wanting to switch faster to the next song, were recorded during the PRM sessions.

Table 2

Feasibility outcomes
Measure	Total (n = 26)	PLM group (n = 14)	PRM group (n = 12)
Recruitment rate	3/month
Participants who completed the study (Retention), n (%)	13 (50)	9 (64)	4 (33)
Participants who discontinued the study (Attrition), n (%)	11 (42)	3 (21)	8 (67)
Intervention sessions completed (Adherence to interventions) n (%)	56 (72)	35 (83)	21 (58)
Pre-post assessments completed (Adherence to assessments), n (%)	34 (45)	26 (62)	18 (50)
Participants who completed the study procedures as per protocol ^a (Adherence to study protocol), n (%)	6 (23)	4 (29)	2 (17)
TF (%) ^b	NR	93% ^c	83% ^d

PLM Preferred Live Music group; PRM Preferred Recorded Music group; TF Treatment Fidelity

^a Patients who completed interventions and assessments as per protocol

^b Treatment Fidelity average success rate per condition

^c Compulsory items 4–6 in checklists are satisfied.

^d Compulsory item 6 in checklists was not satisfied

Secondary clinical outcomes

This feasibility trial did not intend to draw conclusive findings on the effects of MIs on delirium symptoms, and did not need to be adequately powered. Initially aimed to recruit 60 participants, 30 in each arm, to obtain sufficient data to examine the main objectives of the study, while allowing for potential dropouts. An intention-to-treat principle was used to analyse efficacy outcomes, such that the analysis included also those participants who were discharged prior to completion of the three music sessions, or were not able to receive the interventions as per protocol for other reasons. We also intended to complete a per-protocol analysis, but with few participants completing the interventions as described we ultimately opted not to undertake this analysis.

Comparing baseline, and pre-intervention scores showed that delirium symptoms varied during the first three days of the intervention, with measures of level of arousal, attention, orientation and short-term memory fluctuating for most individuals. On average, the participants’ level of arousal was similar across the three assessment days. However, their performance on attention tests improved on day 3 comparing baseline and pre-intervention scores, and was statistically significant for counting from 20 to 1, weekdays backwards, digit span memory test and SAVEAHAART vigilance tests (Table 3).

Table 3

Daily mean score for clinical delirium outcomes and change from baseline
Measure ^b	Day	Mean (95% CI) ^a	Mean difference (95% CI) ^a	p-value
OSLA	Baseline	4.2 (3.1 to 5.3)	Ref.
	Day 1	4.4 (3.3 to 5.5)	0.1 (-1.3 to 1.4)	0.930
	Day 2	4.9 (3.7 to 6.1)	0.3 (-1.1 to 1.7)	0.659
	Day 3	3.4 (2.0 to 4.8)	-0.6 (-2.3 to 1.1)	0.502
mRASS	Baseline	-0.6 (-0.9 to -0.3)	Ref.	0
	Day 1	-0.8 (-1.2 to -0.5)	-0.2 (-0.7 to 0.3)	0.379
	Day 2	-1.0 (-1.4 to -0.6)	-0.3 (-0.8 to 0.2)	0.189
	Day 3	-0.4 (-0.9 to 0.0)	0.2 (-0.4 to 0.7)	0.546
Count 20 to 1	Baseline	8.7 (5.8 to 11.6)	Ref.	0
	Day 1	9.5 (6.4 to 12.6)	0.7 (-2.7 to 4.2)	0.687
	Day 2	9.3 (6.1 to 12.6)	0.5 (-3.1 to 4.1)	0.776
	Day 3	13.9 (10.2 to 17.6)	4.8 (0.5 to 9.0)	0.027
Days of the week	Baseline	3.2 (2.2 to 4.3)	Ref.
	Day 1	4.0 (2.9 to 5.1)	0.7 (-0.6 to 1.9)	0.287
	Day 2	3.5 (2.3 to 4.6)	0.2 (-1.1 to 1.5)	0.779
	Day 3	5.4 (4.1 to 6.8)	2.1 (0.6 to 3.6)	0.006
Months of the year	Baseline	3.1 (1.8 to 4.5)	Ref.
	Day 1	2.7 (1.2 to 4.1)	-0.6 (-2.1 to 1.0)	0.493
	Day 2	3.3 (1.8 to 4.9)	0.2 (-1.5 to 1.8)	0.825
	Day 3	3.3 (1.6 to 5.1)	-0.1 (-2.1 to 1.8)	0.882
Digit span	Baseline	2.8 (2.1 to 3.5)	Ref.
	Day 1	4.0 (3.3 to 4.7)	1.2 (0.4 to 2.0)	0.003
	Day 2	3.2 (2.5 to 4.0)	0.5 (-0.3 to 1.4)	0.205
	Day 3	4.4 (3.6 to 5.3)	1.7 (0.8 to 2.7)	0.001
SAVEAHAART	Baseline	4.1 (2.9 to 5.4)	Ref.
	Day 1	3.6 (2.3 to 5.0)	-0.5 (-1.9 to 1.0)	0.523
	Day 2	3.6 (2.2 to 5.0)	-0.7 (-2.2 to 0.9)	0.398
	Day 3	1.8 (0.2 to 3.3)	-2.3 (-4.1 to -0.6)	0.010
Orientation	Baseline	3.4 (2.5 to 4.3)	Ref.
	Day 1	3.8 (2.9 to 4.7)	0.5 (-0.6 to 1.6)	0.355
	Day 2	3.6 (2.6 to 4.6)	0.2 (-0.9 to 1.3)	0.699
	Day 3	4.8 (3.6 to 5.9)	1.2 (-0.1 to 2.5)	0.073

OSLA Observational Scale of Level of Arousal, mRASS Modified Richmond Agitation Sedation Scale SAVEAHAART/KATAMARAN Vigilance test.

^a Marginal means and mean differences estimated using mixed linear model.

^b Recall is not presented in this table because linear regression was not suitable (see Additional file 5).

There was no significant change in delirium symptoms pre to post MIs on each day. Analysing the data without considering the specific intervention day or group but still considering that each person had up to 7 measures did not show significant change either (Table 4). The individual trajectories showed that some symptoms for given participants did change from pre to post MIs, but these changes were in the negative direction. The residuals for delayed recall score were so skewed that linear modelling of this outcome was not appropriate, and we instead calculated the proportion of the participants who could successfully recall at least one word. The total percentage of the participants who could recall at least one word on the delayed recall test was only 19% (95% CI: 8.2–38.9) (Additional file 5).

Table 4

Before and after music intervention each day
Measure	Day	Before	After	Mean difference (95% CI)	p-value
OSLA	1	4.4 (3.3 to 5.5)	3.7 (2.6 to 4.9)	-0.6 (-2 to 0.8)	0.414
	2	4.9 (3.7 to 6.1)	3.1 (1.9 to 4.4)	-1.4 (-2.9 to 0.2)	0.077
	3	3.4 (2 to 4.8)	3.5 (2.0 to 4.9)	-0.2 (-2.2 to 1.8)	0.837
	Any ^C	4.2 (3.3 to 5.0)	3.5 (2.6 to 4.4)	-0.6 (-1.6 to 0.3)	0.206
mRASS	1	-0.8 (-1.2 to -0.5)	-0.7 (-1 to -0.3)	0.2 (-0.3 to 0.7)	0.401
	2	-1 (-1.4 to -0.6)	-0.6 (-1 to -0.2)	0.3 (-0.2 to 0.8)	0.238
	3	-0.4 (-0.9 to 0)	-0.6 (-1 to -0.1)	-0.1 (-0.7 to 0.6)	0.805
	Any	-0.8 (-1 to -0.5)	-0.6 (-0.9 to -0.4)	0.1 (-0.2 to 0.5)	0.378
Count 20 to 1	1	9.5 (6.4 to 12.6)	8.7 (5.5 to 11.9)	-0.3 (-3.9 to 3.4)	0.889
	2	9.3 (6.1 to 12.6)	11.7 (8.3 to 15.2)	2 (-2 to 5.9)	0.332
	3	13.9 (10.2 to 17.6)	10.9 (6.9 to 14.9)	-3.2 (-8.3 to 2)	0.228
	Any	10.6 (8.2 to 13.1)	10.4 (7.9 to 12.9)	-0.2 (-2.7 to 2.4)	0.904
Days of the week	1	4 (2.9 to 5.1)	4.1 (2.9 to 5.3)	0.2 (-1.1 to 1.5)	0.744
	2	3.5 (2.3 to 4.6)	4.6 (3.4 to 5.8)	1.1 (-0.4 to 2.5)	0.142
	3	5.4 (4.1 to 6.8)	4.7 (3.4 to 6.1)	-0.8 (-2.6 to 0.9)	0.339
	Any	4.2 (3.3 to 5.1)	4.5 (3.5 to 5.4)	0.3 (-0.6 to 1.1)	0.538
Months of the year	1	2.7 (1.2 to 4.1)	3.0 (1.5 to 4.5)	0.5 (-1.1 to 2.2)	0.526
	2	3.3 (1.8 to 4.9)	4.7 (3.1 to 6.3)	1.5 (-0.3 to 3.3)	0.104
	3	3.3 (1.6 to 5.1)	4.2 (2.3 to 6.0)	0.9 (-1.4 to 3.3)	0.435
	Any	3.1 (2 to 4.3)	4.0 (2.8 to 5.2)	1.0 (-0.1 to 2.1)	0.080
Digit span	1	4.0 (3.3 to 4.7)	3.3 (2.6 to 4.1)	-0.6 (-1.5 to 0.3)	0.171
	2	3.2 (2.5 to 4.0)	3.8 (3.0 to 4.6)	0.5 (-0.4 to 1.4)	0.294
	3	4.4 (3.6 to 5.3)	3.7 (2.8 to 4.5)	-0.9 (-2.0 to 0.3)	0.139
	Any	3.8 (3.3 to 4.4)	3.6 (3.0 to 4.2)	-0.3 (-0.8 to 0.3)	0.357
SAVEAHEART	1	3.6 (2.3 to 5.0)	4.0 (2.6 to 5.4)	0.1 (-1.4 to 1.7)	0.869
	2	3.6 (2.2 to 5.0)	3.5 (2.1 to 5.0)	-0.1 (-1.7 to 1.6)	0.915
	3	1.8 (0.2 to 3.3)	2.1 (0.5 to 3.7)	0.3 (-1.7 to 2.3)	0.797
	Any	3.1 (2.1 to 4.2)	3.3 (2.2 to 4.4)	0.1 (-0.9 to 1.1)	0.874
Orientation	1	3.8 (2.9 to 4.7)	3.5 (2.5 to 4.5)	-0.4 (-1.6 to 0.7)	0.476
	2	3.6 (2.6 to 4.6)	4.5 (3.4 to 5.5)	0.8 (-0.4 to 2.1)	0.190
	3	4.8 (3.6 to 5.9)	4.2 (2.9 to 5.4)	-0.5 (-2.1 to 1.1)	0.559
	Any	4.0 (3.3 to 4.8)	4 (3.2 to 4.8)	-0.1 (-0.8 to 0.7)	0.894

OSLA Observational Scale of Level of Arousal, mRASS Modified Richmond Agitation Sedation Scale SAVEAHAART/KATAMARAN Vigilance test.

^a Marginal means and mean differences estimated using mixed linear model.

^b Recall is not presented in this table because linear regression was not suitable.

^c “Any” lines combine information from all days, across the intervention groups, taking into account that each person has up to 7 measures.

There was no evidence of a difference between the participants’ delirium symptoms in PLM or PRM groups on day 3 of the intervention (Additional file 4). Group differences on days 1 and 2 were not examined on the assumption that the potential difference in the effect of the interventions would be most relevant on day 3. The participants’ average length of hospital stays in PLM was 11 days (SD = 8.95) and in PRM 13 days (SD = 8.94); there was no statistically significant group difference between the PLM and PRM (U = 82.500, p = 0.94). The results of Fisher’s exact test did not indicate statistically significant difference between the number of patients receiving PRM medication in the two intervention groups (Additional file 6). There was no sufficient data in the medical journals to estimate changes in delirium duration.

Feasibility outcomes

This feasibility study demonstrated that implementing PLM and PRM with vulnerable delirium patients at the AG ward was feasible and that the MT could successfully conduct music preference assessments. Obtaining music preferences from the legal representatives before engaging in direct, interactive assessments with the patients helped the MT establish a potentially familiar starting point for further assessment based on the dialogic approach and recognition of music examples. Such an approach helped create a personalized environment in which recognition memory could be activated and musical memories retrieved (54). The interactive assessments might also have impacted delirium outcomes prior to the commencement of the MIs and created a confounding variable. They could also have generated expectations regarding upcoming interventions and impacted the participants’ test performance.

Additionally, our study reaffirms prior research indicating hypoactive delirium as the predominant subtype (55, 56), with 68% of our participants exhibiting hypoactive symptoms. Since distinct delirium subtypes present varying symptoms and necessitate different care approaches, it was previously recommended to explore treatment options separately for each subtype (57). This recommendation aligns with our suggestions for further investigation into MIs.

Robust adherence, high TF, relatively high retention rate, consistent dosage delivery, and minimal protocol deviations that PLM demonstrated indicate this intervention is feasible and well accepted. No intervention-related adverse events or unusual treatment effects were recorded, and no refusals further suggest that the PLM is likely safe. Additionally, descriptive data from the MT’s session notes and checklists indicate that PLM might also be engaging, with patients singing, moving to music or reminiscing with the therapist in nearly all the sessions. As 77% of the participants in the PLM had hypoactive delirium, the last finding might be particularly relevant for further exploration of PLM in the treatment of the hypoactive delirium subtype.

PRM exhibited lower adherence, retention, and inconsistent delivery and duration (from 10 to 33 minutes). As discontinuations were mainly associated with patients’ health decline, palliative status and discharge rather than refusals, low adherence and retention might not indicate the PRM’s low acceptability. However, the data from the MTs notes showed that the patients were actively engaged in only about 50% of the sessions and that they more often expressed signs of restlessness, lack of interest in music, desire to fast-forward or switch to the next song, and requested to end the sessions earlier. Such responses suggest that PRM may be experienced as less engaging and monotonous for the patients due to either the non-interactive MT or the delivery format. This finding aligns with our previous assumption that prolonged exposure to complex musical stimuli delivered from a loudspeaker could lead to habituation and boredom in delirium patients (37, 58).

Despite the 83% success rate, PRM did not satisfy TF due to a persistent breach of one of the protocol’s compulsory items regarding prohibited patient-therapist interaction. The interaction was always patient-initiated and related to their confusion, pain, distress, or the need to converse about their experience of music. Although ethically justifiable for addressing patients’ safety and needs, interactions lowered the overall consistency of treatment delivery. Excluding the MT from the room could mitigate this issue in further research. However, it would raise concerns regarding patients’ safety, as unsupervised music exposure may lead to increased confusion and adverse events. Replacing the MT with another health practitioner could be another alternative, in which case any interaction would represent what could be expected in any other setting.

The trial demonstrated that recruitment and assessment procedures were feasible and accurately identified patients with delirium for inclusion. While ensuring a high level of expertise on the patients and the ward, the involvement of the internal assessors, with their high workload and other commitments, resulted in the participants being recruited only when an assessor was available – two workdays during day shifts, to ensure the completion of the assessments/interventions before the weekend. Coupled with strict inclusion criteria, the internal assessors’ limited availability resulted in a low recruitment rate. The engagement of external assessors available in most shifts seven days a week is advised for future research.

The recommended test battery for the pre-post assessments was efficient, accurate in assessing delirium and its features, and suitable for application at the AG ward. However, the completion time varied among the assessors. There is currently no definitive diagnostic test for delirium, so its detection depends on assessing key features, combining observation, cognitive testing, patients’ medical history and clinical interviews (59). Aside from giving a more specific insight into the trajectory of delirium severity by combining continuous (symptom-related) and dichotomous (delirium yes-no) variables, using harmonized test batteries such as ours contributes to developing more robust, reliable and standardized assessments for delirium and its severity in the future (59). The test battery was also well-accepted by delirium patients, with very few refusals, usually related to the severe worsening of their condition. Deviations from the assessment manuals were few and related to either the assessors missing a one-hour time window for assessments or unintentionally omitting some of the tests. However, the lack of post-intervention effects could indicate that time-window for assessments might have been too long and that potential post-intervention effects could have been better captured closer to the end of the interventions. Engaging more flexible external assessors could help address this issue in the future.

Despite the test battery’s high accuracy, efficiency and suitability, the total adherence to the three-day, multiple measures, follow-up protocol was low. However, the assessments were mostly missing due to the unavailable assessors and patients becoming palliative or discharged from the ward. Thus, low adherence might not be the right indicator of the feasibility of the follow-up protocol. Individual trajectories of delirium symptoms showed that some participants had a substantially worse post-intervention performance on some of the cognitive/attention tasks. While the MIs might have caused this worsening, it may also be correlated with the multiple measurements; while providing a large amount of data, the comprehensive three-day, follow-up protocol might have presented a burden for this vulnerable patient group, causing exhaustion, tiredness or boredom, thus negatively impacting their test performance. Therefore, the suitability of the repeated measures design and the length of the follow-up period should be carefully considered in future research.

Clinical outcomes

Our results showed that the participants’ performance on the attention tests improved significantly on day three, when comparing baseline and pre-interventions scores, while most of their other symptoms were similar to baseline. However, without a control group, the observed changes are difficult to attribute to the MIs delivered the previous day, as delirium usually is usually reversed by treatment of underlying causes (7, 60). Nevertheless, the summary evaluation of individual DSM-5 criteria showed that most participants still had delirium at the end of the intervention period.

No statistically significant pre-post intervention changes or inter-group changes in delirium symptoms were observed for any of the measures. However, the trial was underpowered to detect preliminary effectiveness properly. Accordingly, the CIs for mean differences were wide for most measures, and we cannot exclude the possibility of changes in delirium symptoms associated with the interventions. The percentage of participants who could recall at least one word on the delayed recall tests was very low. With small samples in addition, testing pre-post intervention and between the groups change in proportion would have provided no conclusive findings and was omitted. No significant differences in LOS and intake of PRN medication between the groups were expected, as the study was underpowered to provide conclusive findings in this regard, and changes in these measures could be correlated with many other factors. The follow-up of delirium duration after the intervention period was unsuccessful due to the transient and fluctuating delirium nature, making it difficult to ascertain whether it had been recovered.

Despite not showing sensitivity to the MIs, clinical outcomes tested in this trial are still highly relevant for detecting changes in delirium progression and severity and should be included in the future. However, to capture the potential effects of the MIs, other complementing outcomes, such as biomarkers, patient-centred outcomes (emotional responses and engagement), or environmental outcomes related to the medical ward and staff, should be considered and explored. Data from the MT’s session notes and checklists indicated that relevant intervention-related changes might also have occurred during the MI sessions, and it is, therefore, recommended that future trials consider assessing these changes more systematically.

Testing clinical outcomes did not provide sufficient information to discern which of the two MIs could more effectively impact delirium symptoms. The wide CIs are mainly associated with small samples but indicate that the potential effect of PLM and PRM interventions cannot be ruled out.

Strengths and limitations

This trial was sufficiently powered to evaluate feasibility outcomes. However, it was underpowered to investigate the preliminary efficacy and between the groups differences, for which a sample of a minimum of 30 patients per group is recommended (61). The control group was omitted, and comparing two active arms was prioritized due to our primary aim of evaluating the feasibility and uncertainties regarding delirium diagnosis and recruitment. As the design of the previous music and delirium trials has shown to be of low to moderate methodological quality (62), with feasibility appraisals mostly missing, the main strength of our trial is its focus on feasibility and providing valuable insights improving future trials’ design.

Other strengths of this study are: 1) the use of previously validated and recommended delirium assessment procedures (2, 41, 43, 44, 59), 2) training assessors, and 3) involving an experienced delirium researcher to interpret the assessed features. Subtyping delirium is also a strength, and it has been previously recommended for its clinical and prognostic significance in treatment studies (63–65). However, due to small samples, we were not able to conduct separate subgroup analyses with hypoactive and hyperactive delirium patients. We recommend that future studies address delirium subtypes separately, as they may need to be managed differently. Using the staff employed at the site during their usual working hours was a limitation; it resulted in slow recruitment and missed assessments as they were dealing with competing priorities.

Using detailed, standardized intervention protocols with theoretical rationale for comparison, and evaluating TF is also a strength, as it increases the generalizability of effect findings (33). Other strengths are engaging a trained MT and conducting music preference assessments to personalize the interventions and increase relevance and safety, which aligns with previous recommendations (33).

In conclusion, the feasibility of recruitment procedures, music preference assessments, MIs and assessment protocols were indicated, and the results showed that PLM intervention is more engaging, better accepted, and potentially more suitable for further testing with acutely ill older patients with delirium. Recommended next steps are to undertake a pilot study with a comparative group, assess preliminary efficacy, estimate the size of the treatment effects, and to further explore different intervention dosages and frequency of delivery.

AG – Acute Geriatrics

APMP - Assessment of Personal Music Preference tool

CAM-ICU - Confusion Assessment Method for the Intensive Care Unit scale.

CI – Confidence Interval

CONSORT - Consolidated Standards of Reporting Trials.

CSF - Clinical Frailty Scale.

DMSS-4 - Delirium Motor Subtyping Scale.

DOWB – Days of the Week Backwards.

DSM-5 - Diagnostic and Statistical Manual of Mental Disorders, 5th Edition.

FI – Frailty Index.

ICU – Intensive Care Unit.

IQCODE - Informant Questionnaire on Cognitive Decline in the Elderly.

LOS – Length of stay.

MAT – Music Assessment Tool.

MDAS - Memorial Delirium Assessment Scale.

MI – Music Interventions.

MOYB - Months of the Year Backwards.

mRASS - Modified Richmond Agitation Sedation Scale.

MT – Music Therapist

NEWS2 - National Early Warning Score 2.

OSLA - Observational Scale of Level of Arousal.

OUH – Oslo University Hospital.

PLM – Preferred Live Music.

PRM – Preferred Recorded Music.

PRN – Pro Re Nata, non-prescribed psychopharmacological medication.

SAVEHAART – ten-letter vigilance “A” test.

TF – Treatment Fidelity.

Ethics approval and consent to participate

Ethical approval was obtained from the Regional Ethics Committee in Norway (REK 457017). The ability to give informed consent was individually evaluated for each participant, and the consents were obtained by the experienced physicians, either directly from the patient, or supplemented or replaced by the consents from the legally assigned representatives (LAR) if the patient’s ability to consent was reduced. Three different consent forms informing of the study objectives personal data collection methods, benefits and potential risks, data management and the right to withdraw from the study were used. Consents in written format were prioritized, but verbal consents via phone-call were also approved by REK in cases where LAR were not physically present, and the written confirmation was acquired at the first possible occasion.

Consent for publication

Not applicable.

Availability of data and materials

The datasets may be provided by the corresponding author on reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

This study received no external funding and was financed through JG’s PhD Fellowship.

Authors' contributions

All authors meet the criteria for authorship stated in the Uniform Requirements

for Manuscripts Submitted to Biomedical Journals, have read the last draft of the manuscript and agree with the findings presented. JG, BE, FAB, and MRS developed the protocol. FB generated random allocation sequences, and JG randomized the participants, performed the music preference assessments and interventions, and recorded videos for treatment fidelity (TF) evaluation. JG monitored the data collection process. JG assessed and analysed all the feasibility outcomes. JG randomly selected 20% of the participants who completed three sessions and for whom videos were available for TF evaluation using a previously generated randomization sequence. KJ evaluated video recordings and scored treatment delivery checklists, and JG calculated percentages of TF success. JG plotted pre-post delirium data in SPSS, MRS converted some of the data to STATA files, and BEN collected and plotted the medical variables from the electronic journals. Based on the collected pre-post intervention data, BEN completed summary evaluations of delirium, and JG plotted the new variable into the SPSS files. MRS developed a statistical analysis plan and performed the analyses of the pre-post delirium data (mixed linear regression models); JG performed the analysis of all the baseline measures and some of the clinical outcomes (length of hospital stay, medication intake). JG wrote the manuscript with FAB, BEN, MRS, and KJ contributions. All the authors have read and agreed to the published version of the manuscript.

Acknowledgements

We wish to thank Oslo University Hospital (OUH) for being the main sponsor and the host of the project and the Norwegian Academy of Music (NMH) for being the collaborating institution and providing funding for JG’s PhD project of which this feasibility study is a part. We also acknowledged the Centre for Research in Music and Health (CREMAH) at NMH and the Director, Prof. Karette Stensæth, for support and valuable discussions during the process. We are particularly grateful to Prof. Torgeir Bruun Wyller, Prof. Leiv Otto Watne, and other members of Oslo Delirium Research for generous and constructive feedback and continuous support, as well as Dr. Marc Ahmed, Dr. Nina Ommundsen, along with all the assessors/geriatricians, patients and their families from the Acute Geriatric Section (OUH).

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No competing interests reported.

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A Randomized Pilot and Feasibility Trial of Live and Recorded Music Interventions for Management of Delirium Symptoms in Acute Geriatric Patients

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Abstract

Background

Methods

Results

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Background and objectives

Methods

Trial design

Participants

Randomization and Masking

Interventions and comparators

Outcomes

Statistical methods

Results

Participants flow and recruitment

Feasibility Outcomes

Secondary clinical outcomes

Discussion

Feasibility outcomes

Clinical outcomes

Strengths and limitations

Abbreviations

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References

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Supplementary Files

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