EMPIRE: The Effect of Music on Patients in Critical Care
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Music listening experience 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.
|
Outcome Measures
Primary Outcome Measures
- 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 RR [6 months]
Measured in breaths 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
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Nominated for participation by the clinical team of the Chelsea and Westminster Hospital AICU
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Level 1-3 critical care inpatient at Chelsea and Westminster Hospital AICU
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Age 18 or above
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English speaking
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RASS score >-2
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No significant hearing loss (able to hear music being played)
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Consent obtained from patient or advice sought from consultee (personal or nominated (professional))
Exclusion Criteria:
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Under 18 years of age
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Non-English speaking
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RASS score <-2
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Significant hearing loss (not able to hear music being played)
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Unable to obtain consent from patient or receive advice from consultee (personal or nominated)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chelsea and Westminster Hospital NHS Foundation Trust | London | United Kingdom | SW10 9NH |
Sponsors and Collaborators
- Chelsea and Westminster NHS Foundation Trust
- CW plus
- Imperial College London
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
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- Benotsch EG, Lutgendorf SK, Watson D, Fick LJ, Lang EV. Rapid anxiety assessment in medical patients: evidence for the validity of verbal anxiety ratings. Ann Behav Med. 2000 Summer;22(3):199-203.
- Bradt J, Dileo C. Music interventions for mechanically ventilated patients. Cochrane Database Syst Rev. 2014;(12):CD006902. doi: 10.1002/14651858.CD006902.pub3. Epub 2014 Dec 9. Review.
- Cardoso, L. et al. (2017) 'Music therapy as an autonomous intervention of nurses for pain control in icu: integrative review', Millenium - Journal of Education, Technologies, and Health, 2(04), pp. 89-100. doi: 10.29352/mill0204.08.00148.
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- Davydow DS, Gifford JM, Desai SV, Needham DM, Bienvenu OJ. Posttraumatic stress disorder in general intensive care unit survivors: a systematic review. Gen Hosp Psychiatry. 2008 Sep-Oct;30(5):421-34. doi: 10.1016/j.genhosppsych.2008.05.006. Epub 2008 Jul 30. Review.
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- Han L, Li JP, Sit JW, Chung L, Jiao ZY, Ma WG. Effects of music intervention on physiological stress response and anxiety level of mechanically ventilated patients in China: a randomised controlled trial. J Clin Nurs. 2010 Apr;19(7-8):978-87. doi: 10.1111/j.1365-2702.2009.02845.x.
- Jafari H, Emami Zeydi A, Khani S, Esmaeili R, Soleimani A. The effects of listening to preferred music on pain intensity after open heart surgery. Iran J Nurs Midwifery Res. 2012 Jan;17(1):1-6.
- Kyavar, M. et al. (2016) 'Effect of preferred music listening on pain reduction in mechanically ventilated patients after coronary artery bypass graft surgery', Research in Cardiovascular Medicine, 5(4), p. 8. doi: 10.5812/cardiovascmed.33769.
- Lee CH, Lee CY, Hsu MY, Lai CL, Sung YH, Lin CY, Lin LY. Effects of Music Intervention on State Anxiety and Physiological Indices in Patients Undergoing Mechanical Ventilation in the Intensive Care Unit. Biol Res Nurs. 2017 Mar;19(2):137-144. doi: 10.1177/1099800416669601. Epub 2016 Sep 21.
- Lee OK, Chung YF, Chan MF, Chan WM. Music and its effect on the physiological responses and anxiety levels of patients receiving mechanical ventilation: a pilot study. J Clin Nurs. 2005 May;14(5):609-20.
- Nilsson U. The anxiety- and pain-reducing effects of music interventions: a systematic review. AORN J. 2008 Apr;87(4):780-807. doi: 10.1016/j.aorn.2007.09.013. Review.
- Richard-Lalonde M, Gélinas C, Boitor M, Gosselin E, Feeley N, Cossette S, Chlan LL. The Effect of Music on Pain in the Adult Intensive Care Unit: A Systematic Review of Randomized Controlled Trials. J Pain Symptom Manage. 2020 Jun;59(6):1304-1319.e6. doi: 10.1016/j.jpainsymman.2019.12.359. Epub 2019 Dec 24.
- Samuelson KA. Unpleasant and pleasant memories of intensive care in adult mechanically ventilated patients--findings from 250 interviews. Intensive Crit Care Nurs. 2011 Apr;27(2):76-84. doi: 10.1016/j.iccn.2011.01.003. Epub 2011 Mar 2.
- Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44.
- Stratton, V. N. and Zalanowski, A. H. (1984) 'The relationship between music, degree of liking, and self-reported relaxation', Journal of Music Therapy, 21(4), pp. 184-192. doi: 10.1093/jmt/21.4.184.
- C&W21/009