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

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ClinicalTrials.gov Identifier: NCT04847570
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : August 6, 2021
Sponsor:
Collaborators:
CW plus
Imperial College London
Information provided by (Responsible Party):
Chelsea and Westminster NHS Foundation Trust

Study Description
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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
Intensive Care Other: Music session Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Non-clinical intervention
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Music on Patients in Critical Care (EMPIRE)
Actual Study Start Date : April 13, 2021
Estimated Primary Completion Date : October 4, 2021
Estimated Study Completion Date : October 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Investigate the effect of music on state anxiety [ Time Frame: 6 months ]
    Verbal anxiety rating, 0-10, pre/post.

  2. Investigate the effect of music on pain [ Time Frame: 6 months ]
    Either ONRS 0-10, or C-POT 0-8, pre/post

  3. Investigate the effect of music on agitation [ Time Frame: 6 months ]
    RASS, -5 to +4, pre-/post

  4. Investigate the effect of music on HR [ Time Frame: 6 months ]
    Measured in beats per minute

  5. Investigate the effect of music on RR [ Time Frame: 6 months ]
    Measured in breaths per minute

  6. Investigate the effect of music on DBP and SBP [ Time Frame: 6 months ]
    Measured in mm Hg

  7. Investigate the effect of music on BIS [ Time Frame: 6 months ]
    Measured using the Bispectral index (BIS)

  8. Investigate the longitudinal effects of music on ICU experience [ Time Frame: 3 months ]
    Follow up interview 3 months later


Secondary Outcome Measures :
  1. Correlation analysis of continuous HR, RR, BP and BIS data with the following musical analysis data (drawn from the Spotify API): [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04847570


Contacts
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Contact: Research Delivery Operations Manager 020 3315 6825 research.development@nhs.net

Locations
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United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SW10 9NH
Contact: Damon Foster       research.development@nhs.net   
Contact: Marcela Vizcaychipi       Marcela.Vizcaychipi@chelwest.nhs.uk   
Principal Investigator: Marcela Vizcaychipi         
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
CW plus
Imperial College London
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
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.
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.
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.

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Responsible Party: Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04847570    
Other Study ID Numbers: C&W21/009
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chelsea and Westminster NHS Foundation Trust:
Music
AICU
Inpatient