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

Pain Clinical Trial

— MUSICU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174662
• Other study ID #: MUSICU
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2024
• Source: Universiteit Antwerpen
• Contact: Lotte Heirbaut, RN
• Phone: 003232659169
• Email: lotte.heirbaut[@]student.uantwerpen.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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, the investigators 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. The investigators 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, the investigators 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Pain
• Stress

Intervention

Device:
• Music
The patient can decide the music genre (a standard playlist) and receives a noise-cancelling headphone playing the chosen music during mobilization.

Locations

Country	Name	City	State
Belgium	University of Antwerp	Wilrijk	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Time of mobilization	Time in minutes of mobilization	Ten minutes before mobilization begins and ten minutes after mobilization is completed
Secondary	Blood pressure	Systolic Blood Pressure	Ten minutes before mobilization begins and ten minutes after mobilization is completed
Secondary	Heart rate	Heart frequency per minute	Ten minutes before mobilization begins and ten minutes after mobilization is completed
Secondary	Respiratory frequency	Respiratory frequency per minute	Ten minutes before mobilization begins and ten minutes after mobilization is completed