University of Antwerp
Wilrijk, Antwerp, 2610, Belgium
Location status: Recruiting
NCT Number: NCT06174662
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).
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Request Info18 year and older
All sexes
Interventional
Not applicable
Wilrijk, Antwerp, 2610, Belgium
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patient can decide the music genre (a standard playlist) and receives a noise-cancelling headphone playing the chosen music during mobilization.
Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's pain level
Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's stress level.
Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's anxiety level.
Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Time in minutes of mobilization
Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Systolic Blood Pressure
Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Heart frequency per minute
Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Respiratory frequency per minute
Contact information is provided by the study sponsor or research team.
Filip Haegdorens, PhD
CONTACT
Lotte Heirbaut, RN
CONTACT
Universiteit Antwerpen
Other
Acronym: MUSICU
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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