Clinical trial NCT06174662: The Effect of Music on Procedural Distress During Mobilization in Intensive Care Unit Patients: A Randomized Controlled Trial
Official title: The Effect of Music on Procedural Distress During Mobilization in Intensive Care Unit Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Stress
Anxiety
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial (RCT) with parallel arms: control and intervention group. Not blinded.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: pain perception level
timeFrame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
measure: stress perception level
timeFrame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
measure: anxiety perception level
timeFrame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Secondary outcomes:
measure: Time of mobilization
timeFrame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
measure: Blood pressure
timeFrame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
measure: Heart rate
timeFrame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
measure: Respiratory frequency
timeFrame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: University of Antwerp
state: Antwerp
Study officials:
References: