Live Music in the Intensive Care Unit

NCT06442644 | Not Yet Recruiting

• 1 other identifier: 1-10-72-66-24
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this quasi-experimental pre- post test study is to test a patient-tailored live music intervention's effect on stress and pain reduction in adult, critically ill patients admitted to the intensive care unit. The main question it aims to answer is: • Does live music reduce stress and pain in adult intensive care patients? In the pre-post test design, the patients will be their own control. There will be no randomisation. Researchers will compare measurements of heartrate, respiration rate, heartrate variability, blood pressure and pain before and after the live music intervention to see if live music effects these vital parameters. Participants will listen to live music in their room in the intensive care unit for 5 to 15 minutes.

Conditions

Stress; Pain

Keywords

Intensive care unit; Live music; Quantitative; Stress; Pain

Outcome Measures

Primary Outcomes (1)

• Heartrate variability

  measured via the HeartMath Sensor, which is validated for measuring stress levels

  baseline (10 minutes before listening to live music), during (5-15 minutes of listening to live music), after (10 minutes after listening to live music)

Secondary Outcomes (5)

• Heartrate

  baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)

• The patient's subjective pain experience via a numerical ranking scale (NRS)

  baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)

• Patient's self-reported stress level measured by STAI (State-Trait Anxiety Inventory) a validated short version to measure the stress level.

  baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)

• Blood pressure

  baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)

• Respiration rate

  baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)

Study Arms (1)

Adult intensive care patients

OTHER

Live music interventions

Other: Live music in the intensive care unit

Interventions

Live music in the intensive care unit OTHER

To test a patient-tailored live music intervention's effect on stress reduction in adult, critically ill patients admitted to the intensive care unit.

Adult intensive care patients

Eligibility Criteria

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

You may qualify if:

• Adults (\>18 years)
• Admitted to one of the four participating ICU departments for a minimum of 24 hours
• Able to read and speak Danish
• For incapable patients, it is necessary to have a close relative (e.g., spouse or adult child), as these will provide proxy consent for study participation

You may not qualify if:

• Unstable patients with a need of change/adjustment of the ongoing treatment of e.g. drug infusions or ventilator settings during the music intervention, as this can possibly affect the HRV measurements.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Region MidtJylland Denmark: collaborator
• Novo Nordisk A/S: collaborator
• The Royal Conservatory of Music: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, Central Jutland, 8200, Denmark

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Linette Thorn, Master

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linette Thorn, Master

CONTACT

+0045 28917602; linlauri@rm.dk

Anna Holm, post. doc

CONTACT

annasoe6@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialized intensive care nurse

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: June 4, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)