Clinical trial NCT04847570: The Effect of Music on Patients in Critical Care
Official title: The Effect of Music on Patients in Critical Care (EMPIRE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intensive Care
Keywords: Music
AICU
Inpatient
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: CW+ Charity
name: Imperial College London
First posted: 2021-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-clinical intervention
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Investigate the effect of music on state anxiety
timeFrame: 6 months
measure: Investigate the effect of music on pain
timeFrame: 6 months
measure: Investigate the effect of music on agitation
timeFrame: 6 months
measure: Investigate the effect of music on HR
timeFrame: 6 months
measure: Investigate the effect of music on RR
timeFrame: 6 months
measure: Investigate the effect of music on DBP and SBP
timeFrame: 6 months
measure: Investigate the effect of music on BIS
timeFrame: 6 months
measure: Investigate the longitudinal effects of music on ICU experience
timeFrame: 3 months
Secondary outcomes:
measure: Correlation analysis of continuous HR, RR, BP and BIS data with the following musical analysis data (drawn from the Spotify API):
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust
Study officials:
References:
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