The Effect of Music on Patients in Critical Care

Intensive Care Clinical Trial

— EMPIRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04847570
• Other study ID #: C&W21/009
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: October 4, 2021

Study information

• Verified date: August 2021
• Source: Chelsea and Westminster NHS Foundation Trust
• Contact: Research Delivery Operations Manager
• Phone: 020 3315 6825
• Email: research.development[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 4, 2021
• Est. primary completion date: October 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Intensive Care

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster Hospital NHS Foundation Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
Chelsea and Westminster NHS Foundation Trust	CW plus, Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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.

Chanques G, Viel E, Constantin JM, Jung B, de Lattre S, Carr J, Cissé 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. — View Citation

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. — View Citation

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. — View Citation

Gélinas 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

* Note: There are 18 references in all — Click here to view all references

Outcome

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