The Effect of Music on Procedural Distress During Mobilization in Intensive Care Unit Patients: A Randomized Controlled Trial
- Conditions
- PainAnxietyStress
- Interventions
- Device: Music
- Registration Number
- NCT06174662
- Lead Sponsor
- Universiteit Antwerpen
- Brief 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).
- 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, 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 128
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Music Music Music through noise cancelling headphones.
- Primary Outcome Measures
Name Time Method pain perception level 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
stress perception level 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.
anxiety perception level 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.
- Secondary Outcome Measures
Name Time Method Time of mobilization Ten minutes before mobilization begins and ten minutes after mobilization is completed Time in minutes of mobilization
Respiratory frequency Ten minutes before mobilization begins and ten minutes after mobilization is completed Respiratory frequency per minute
Blood pressure Ten minutes before mobilization begins and ten minutes after mobilization is completed Systolic Blood Pressure
Heart rate Ten minutes before mobilization begins and ten minutes after mobilization is completed Heart frequency per minute
Trial Locations
- Locations (1)
University of Antwerp
🇧🇪Wilrijk, Antwerp, Belgium