The Effect of Music on Patients in Critical Care

NCT04847570 | Unknown

• 1 other identifier: C&W21/009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care

Keywords

Music; AICU; Inpatient

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Correlation analysis of continuous HR, RR, BP and BIS data with the following musical analysis data (drawn from the Spotify API):

  6 months

Study Arms (1)

Music listening experience

EXPERIMENTAL

It is a single-arm non-randomised study. The same inclusion and exclusion criteria applies to all the participants.

Other: Music session

Interventions

Music session OTHER

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.

Music listening experience

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead
• CW+ Charity: collaborator
• Imperial College London: collaborator

Study Sites (1)

Chelsea and Westminster Hospital NHS Foundation Trust

London, SW10 9NH, United Kingdom

RECRUITING

Related Publications (18)

• 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.

  PMID: 28904523 BACKGROUND

• 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.

  PMID: 11126464 BACKGROUND

• 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.

  PMID: 25490233 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 20843604 BACKGROUND

• 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.

  PMID: 17322014 BACKGROUND

• 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.

  PMID: 18774425 BACKGROUND

• 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.

  PMID: 16823021 BACKGROUND

• 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.

  PMID: 20492042 BACKGROUND

• 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.

  PMID: 23493927 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 27655993 BACKGROUND

• 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.

  PMID: 15840076 BACKGROUND

• 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.

  PMID: 18395022 BACKGROUND

• 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.

  PMID: 31881291 BACKGROUND

• 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.

  PMID: 21371888 BACKGROUND

• 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.

  PMID: 12421743 BACKGROUND

• 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.

  BACKGROUND

Central Study Contacts

Research Delivery Operations Manager

CONTACT

020 3315 6825; research.development@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-clinical intervention

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 19, 2021
• Study Start: April 13, 2021
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)