The Effect of Music on Patients in Critical Care
- Conditions
- Intensive Care
- Interventions
- Other: Music session
- Registration Number
- NCT04847570
- Lead Sponsor
- Chelsea and Westminster NHS Foundation Trust
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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))
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Music listening experience Music session It is a single-arm non-randomised study. The same inclusion and exclusion criteria applies to all the participants.
- Primary Outcome Measures
Name Time Method Investigate the effect of music on RR 6 months Measured in breaths per minute
Investigate the effect of music on state anxiety 6 months Verbal anxiety rating, 0-10, pre/post.
Investigate the effect of music on pain 6 months Either ONRS 0-10, or C-POT 0-8, pre/post
Investigate the effect of music on agitation 6 months RASS, -5 to +4, pre-/post
Investigate the effect of music on HR 6 months Measured in beats per minute
Investigate the effect of music on DBP and SBP 6 months Measured in mm Hg
Investigate the effect of music on BIS 6 months Measured using the Bispectral index (BIS)
Investigate the longitudinal effects of music on ICU experience 3 months Follow up interview 3 months later
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
Chelsea and Westminster Hospital NHS Foundation Trust
🇬🇧London, United Kingdom