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

C

Chelsea and Westminster NHS Foundation Trust

Status

Unknown

Conditions

Intensive Care

Treatments

Other: Music session

Study type

Interventional

Funder types

Other

Identifiers

NCT04847570
C&W21/009

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Music listening experience
Experimental group
Description:
It is a single-arm non-randomised study. The same inclusion and exclusion criteria applies to all the participants.
Treatment:
Other: Music session

Trial contacts and locations

1

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Central trial contact

Research Delivery Operations Manager

Data sourced from clinicaltrials.gov

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