The Effect of Music on Procedural Distress During Mobilization in Intensive Care Unit Patients: A Randomized Controlled Trial (MUSICU)

This intervention study will investigate the effects of music therapy on procedural distress, the overall experience of pain, anxiety, and stress, during the procedure of sitting up in a chair for patients admitted to the intensive care unit (ICU).

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Stress; Anxiety
• Intervention / Treatment: Device: Music

Detailed Description

There is a paucity of literature on the use of music therapy ('music care') in intensive care units (ICUs) during the process of mobilization. However, research suggests that mobilization can reduce the risk of depression and improve cognitive function (Chiang et al., 2006). This study aims to investigate the impact of music therapy on procedural comfort during sit-to-stand mobilization in ICU patients.

Specifically, we seek to examine the effects of music therapy on pain perception, stress levels, anxiety levels, and vital parameters (blood pressure, heart rate, and respiratory rate) during this procedure. We hypothesize that music therapy can improve procedural comfort by reducing pain, stress, and anxiety.

This study employs quantitative multicenter research, specifically a randomized controlled trial (RCT), involving ICU patients at three hospitals: AZ Monica Deurne, GZA campus Sint-Augustinus, and Sint-Vincentius.

During the intervention, patients will listen to their preferred music through noise-canceling headphones. Patients will be able to select their preferred music.

To assess the effects of music therapy, we developed a self-designed measurement tool, validated using content validation indices (CVI) with an expert panel including pain nurses. The tool measures various indicators, including:

Vital parameters: (arterial) blood pressure, heart rate, and respiratory rate

Pain perception: Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's pain level. Zero indicates no pain, while 10 represents the worst imaginable pain.

Anxiety and stress levels: Nurses will utilize 11-point Likert scales from 0 to 10 to measure the patient's anxiety and stress levels. The sum of these three scores will provide an overall measure of procedural distress.

To assess the duration of the effects of music therapy, we will record the above indicators at four time points:

Time 0: Ten minutes before sit-to-stand mobilization begins

Time 1: Ten minutes after sit-to-stand mobilization is completed

Time 2: Immediately before returning the patient to bed, after music stops

Time 3: Ten minutes after the patient is back in bed

Delta calculations will be performed to measure changes between time points.

The selected music playlist will be briefly noted on the measurement tool, and a final Likert scale will assess patient satisfaction with the intervention.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lotte Heirbaut, RN; Phone Number: 003232659169; Email: lotte.heirbaut@student.uantwerpen.be
• Study Contact Backup: Name: Filip Haegdorens, PhD; Phone Number: 003232659169; Email: filip.haegdorens@uantwerpen.be

Study Locations

• Belgium
  • Antwerp
    • Wilrijk, Antwerp, Belgium, 2610
      • University of Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• They are admitted to the ICU
• They have a Richmond Agitation-Sedation Scale (RASS) score of +1, 0, or -1
• They are able to speak Dutch

Exclusion Criteria:

• They are younger than 18 years old
• They have a hearing impairment
• They are in isolation
• They have a cranial dressing or intracranial pressure monitoring

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music; Music through noise cancelling headphones.	Device: Music; The patient can decide the music genre (a standard playlist) and receives a noise-cancelling headphone playing the chosen music during mobilization.
No Intervention: No music; Control group receiving regular care. No music will be offered to the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain perception level	Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's pain level	Ten minutes before mobilization begins and ten minutes after mobilization is completed
stress perception level	Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's stress level.	Ten minutes before mobilization begins and ten minutes after mobilization is completed
anxiety perception level	Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's anxiety level.	Ten minutes before mobilization begins and ten minutes after mobilization is completed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of mobilization	Time in minutes of mobilization	Ten minutes before mobilization begins and ten minutes after mobilization is completed
Blood pressure	Systolic Blood Pressure	Ten minutes before mobilization begins and ten minutes after mobilization is completed
Heart rate	Heart frequency per minute	Ten minutes before mobilization begins and ten minutes after mobilization is completed
Respiratory frequency	Respiratory frequency per minute	Ten minutes before mobilization begins and ten minutes after mobilization is completed

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Estimated): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MUSICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data can be shared on request

Drug and device information, study documents

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