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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intensive Care
• Intervention / Treatment: Other: Music session

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Delivery Operations Manager; Phone Number: 020 3315 6825; Email: research.development@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, SW10 9NH
    • Recruiting
    • Chelsea And Westminster Hospital NHS Foundation Trust
    • Contact: Damon Foster; Email: research.development@nhs.net
    • Contact: Marcela Vizcaychipi; Email: Marcela.Vizcaychipi@chelwest.nhs.uk
    • Principal Investigator: Marcela Vizcaychipi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate the effect of music on state anxiety	Verbal anxiety rating, 0-10, pre/post.	6 months
Investigate the effect of music on pain	Either ONRS 0-10, or C-POT 0-8, pre/post	6 months
Investigate the effect of music on agitation	RASS, -5 to +4, pre-/post	6 months
Investigate the effect of music on HR	Measured in beats per minute	6 months
Investigate the effect of music on RR	Measured in breaths per minute	6 months
Investigate the effect of music on DBP and SBP	Measured in mm Hg	6 months
Investigate the effect of music on BIS	Measured using the Bispectral index (BIS)	6 months
Investigate the longitudinal effects of music on ICU experience	Follow up interview 3 months later	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 months

Collaborators and Investigators

• Sponsor: Chelsea and Westminster NHS Foundation Trust
• Collaborators: Imperial College London; CW plus

Publications and helpful links

General Publications

• 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.
• 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. doi: 10.1164/rccm.2107138.
• Chanques G, Viel E, Constantin JM, Jung B, de Lattre S, Carr J, Cisse M, Lefrant JY, Jaber S. The measurement of pain in intensive care unit: comparison of 5 self-report intensity scales. Pain. 2010 Dec;151(3):711-721. doi: 10.1016/j.pain.2010.08.039. Epub 2010 Sep 16.
• Gelinas C, Fillion L, Puntillo KA, Viens C, Fortier M. Validation of the critical-care pain observation tool in adult patients. Am J Crit Care. 2006 Jul;15(4):420-7.
• 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.
• 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.
• 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. doi: 10.1007/BF02895114.
• Bradt J, Dileo C. Music interventions for mechanically ventilated patients. Cochrane Database Syst Rev. 2014;2014(12):CD006902. doi: 10.1002/14651858.CD006902.pub3. Epub 2014 Dec 9.
• 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.
• Ames N, Shuford R, Yang L, Moriyama B, Frey M, Wilson F, Sundaramurthi T, Gori D, Mannes A, Ranucci A, Koziol D, Wallen GR. Music Listening Among Postoperative Patients in the Intensive Care Unit: A Randomized Controlled Trial with Mixed-Methods Analysis. Integr Med Insights. 2017 Jul 20;12:1178633717716455. doi: 10.1177/1178633717716455. eCollection 2017.
• 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.
• Chlan LL, Engeland WC, Anthony A, Guttormson J. Influence of music on the stress response in patients receiving mechanical ventilatory support: a pilot study. Am J Crit Care. 2007 Mar;16(2):141-5.
• 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 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. doi: 10.1111/j.1365-2702.2004.01103.x.
• Richard-Lalonde M, Gelinas 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2021
• Primary Completion (Anticipated): October 4, 2021
• Study Completion (Anticipated): October 4, 2021

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Music; Inpatient; AICU
• Other Study ID Numbers: C&W21/009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No