The Effect of Music on Patients in Critical Care

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intensive Care

Intervention / Treatment
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* Other: Music session


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Non-clinical intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music listening experience<br>It is a single-arm non-randomised study. The same inclusion and exclusion criteria applies to all the participants. | Other: Music session<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the effect of music on state anxiety | Verbal anxiety rating, 0-10, pre/post. | 6 months | 
| Investigate the effect of music on pain | Either ONRS 0-10, or C-POT 0-8, pre/post | 6 months | 
| Investigate the effect of music on agitation | RASS, -5 to +4, pre-/post | 6 months | 
| Investigate the effect of music on HR | Measured in beats per minute | 6 months | 
| Investigate the effect of music on RR | Measured in breaths per minute | 6 months | 
| Investigate the effect of music on DBP and SBP | Measured in mm Hg | 6 months | 
| Investigate the effect of music on BIS | Measured using the Bispectral index (BIS) | 6 months | 
| Investigate the longitudinal effects of music on ICU experience | Follow up interview 3 months later | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation analysis of continuous HR, RR, BP and BIS data with the following musical analysis data (drawn from the Spotify API): | 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) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music, AICU, Inpatient