The Effect of Music on Procedural Distress During Mobilization in Intensive Care Unit Patients: A Randomized Controlled Trial
NCT ID: NCT06174662
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
128 participants
INTERVENTIONAL
2024-02-02
2025-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Music
Music through noise cancelling headphones.
Music
The patient can decide the music genre (a standard playlist) and receives a noise-cancelling headphone playing the chosen music during mobilization.
No music
Control group receiving regular care. No music will be offered to the patient.
No interventions assigned to this group
Interventions
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Music
The patient can decide the music genre (a standard playlist) and receives a noise-cancelling headphone playing the chosen music during mobilization.
Eligibility Criteria
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Inclusion Criteria
* They have a Richmond Agitation-Sedation Scale (RASS) score of +1, 0, or -1
* They are able to speak Dutch
Exclusion Criteria
* They have a hearing impairment
* They are in isolation
* They have a cranial dressing or intracranial pressure monitoring
18 Years
ALL
No
Sponsors
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Universiteit Antwerpen
OTHER
Responsible Party
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Filip Haegdorens
Assistant professor
Locations
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University of Antwerp
Wilrijk, Antwerp, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MUSICU
Identifier Type: -
Identifier Source: org_study_id
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