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The Effect of Music on Patients in Critical Care

The Effect of Music on Patients in Critical Care (EMPIRE)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04847570
Acronym
EMPIRE
Enrollment
30
Registered
2021-04-19
Start date
2021-04-13
Completion date
2021-10-04
Last updated
2021-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care

Keywords

Music, AICU, Inpatient

Brief summary

The EMPIRE study will assess the effect of music listening on patients in critical care. 30 patients from the Adult Intensive Care Unit (AICU) at Chelsea and Westminster Hospital will be recruited to undergo a single 40-minute session of supervised music listening. Before and after the session, patients will be asked to describe their pain and anxiety on a rating of 1-10, and the patient's level of agitation/sedation will also be measured. In addition, physiological data such as heart rate, respiratory rate, blood pressure and level of sedation (bispectral index score) will be measured throughout the listening session. Finally, a 3-month follow-up interview will be conducted to assess the influence of the music on participants' experience of the Adult Intensive Care Unit.

Detailed description

The EMPIRE study will assess the effect of music listening on patients in critical care. Treatment on an intensive care unit can be disorientating and frightening, with patients at risk of delirium and post-traumatic stress disorder. The COVID-19 pandemic has exacerbated some of the factors which might contribute to this, such as lack of visits from relatives and friends, increased difficulty communicating with staff, and an increased likelihood of being on mechanical ventilation and sedation. Music has shown the potential to be a low-cost non-pharmacological intervention which can improve patients' experience of acute care without adding significantly to the workload of staff. Studies have suggested that music listening has the potential to reduce feelings of pain and anxiety in critical care patients, as well as improved autonomic physiological outcomes such as heart rate, respiratory rate and blood pressure. The EMPIRE study will seek to explore the effects described above in greater detail. 30 patients from the Adult Intensive Care Unit (AICU) at Chelsea and Westminster Hospital will be recruited to undergo a single 40-minute session of supervised music listening, in which they will be encouraged to request their favourite music if they are able. Before and after the session, patients will be asked to describe their pain and anxiety on a rating of 1-10, and the patient's level of agitation/sedation will also be measured, so that changes in these can be evaluated. In addition, physiological data such as heart rate, respiratory rate, blood pressure and level of sedation (bispectral index score) will be measured throughout the listening session, and later analysed for significant changes in relation to the music that was being played. Finally, a 3-month follow-up interview will be conducted to assess the influence of the music on participants' experience of the Adult Intensive Care Unit.

Interventions

Non-clinical intervention only, and no change to clinical care or treatment. Participants will have 10 minutes of undisturbed rest, followed by a supervised music-listening session of up to 40 minutes, ending with another 10-minute rest period.

Sponsors

CW+ Charity
CollaboratorOTHER
Imperial College London
CollaboratorOTHER
Chelsea and Westminster NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Non-clinical intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Nominated for participation by the clinical team of the Chelsea and Westminster Hospital AICU * Level 1-3 critical care inpatient at Chelsea and Westminster Hospital AICU * Age 18 or above * English speaking * RASS score \>-2 * No significant hearing loss (able to hear music being played) * Consent obtained from patient or advice sought from consultee (personal or nominated (professional))

Exclusion criteria

* Under 18 years of age * Non-English speaking * RASS score \<-2 * Significant hearing loss (not able to hear music being played) * Unable to obtain consent from patient or receive advice from consultee (personal or nominated)

Design outcomes

Primary

MeasureTime frameDescription
Investigate the effect of music on DBP and SBP6 monthsMeasured in mm Hg
Investigate the effect of music on BIS6 monthsMeasured using the Bispectral index (BIS)
Investigate the longitudinal effects of music on ICU experience3 monthsFollow up interview 3 months later
Investigate the effect of music on state anxiety6 monthsVerbal anxiety rating, 0-10, pre/post.
Investigate the effect of music on pain6 monthsEither ONRS 0-10, or C-POT 0-8, pre/post
Investigate the effect of music on agitation6 monthsRASS, -5 to +4, pre-/post
Investigate the effect of music on HR6 monthsMeasured in beats per minute
Investigate the effect of music on RR6 monthsMeasured in breaths per minute

Secondary

MeasureTime frameDescription
Correlation analysis of continuous HR, RR, BP and BIS data with the following musical analysis data (drawn from the Spotify API):6 months* Acousticness (0-1) * Danceability (0-1) * Duration (continuous) * Energy (0-1) * Instrumentalness (0-1) * Key (0-11) * Liveness (0-1) * Loudness (db, c.-60 to 0) * Mode (0-1) * Speechiness (0-1) * Tempo (continuous) * Time Signature (continuous) * Valence (0-1)

Countries

United Kingdom

Contacts

Primary ContactResearch Delivery Operations Manager
research.development@nhs.net020 3315 6825

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026