An interventional study of Music session in Intensive Care, sponsored by Chelsea and Westminster NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-06.
Sponsored by Chelsea and Westminster NHS Foundation Trust · Not applicable, Interventional, and Other
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.
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.
Chelsea and Westminster NHS Foundation Trust is the lead sponsor of 53 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
It is a single-arm non-randomised study. The same inclusion and exclusion criteria applies to all the participants.
Other: Music session
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.
Investigate the effect of music on state anxiety
Verbal anxiety rating, 0-10, pre/post.
Time frame: 6 months
Investigate the effect of music on pain
Either ONRS 0-10, or C-POT 0-8, pre/post
Time frame: 6 months
Investigate the effect of music on agitation
RASS, -5 to +4, pre-/post
Time frame: 6 months
Investigate the effect of music on HR
Measured in beats per minute
Time frame: 6 months
Investigate the effect of music on RR
Measured in breaths per minute
Time frame: 6 months
Investigate the effect of music on DBP and SBP
Measured in mm Hg
Time frame: 6 months
Investigate the effect of music on BIS
Measured using the Bispectral index (BIS)
Time frame: 6 months
Investigate the longitudinal effects of music on ICU experience
Follow up interview 3 months later
Time frame: 3 months
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)
Time frame: 6 months
Plan to share: No
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Chelsea and Westminster NHS Foundation Trust