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

Study Overview
=================
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, we 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. We 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, we 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.

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

Conditions
-----------------
Pain, Stress, Anxiety

Intervention / Treatment
-----------------
* Device: Music


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial (RCT) with parallel arms: control and intervention group. Not blinded.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music<br>Music through noise cancelling headphones. | Device: Music<br>* The patient can decide the music genre (a standard playlist) and receives a noise-cancelling headphone playing the chosen music during mobilization.<br>|
| No Intervention: No music<br>Control group receiving regular care. No music will be offered to the patient. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of mobilization | Time in minutes of mobilization | Ten minutes before mobilization begins and ten minutes after mobilization is completed | 
| Blood pressure | Systolic Blood Pressure | Ten minutes before mobilization begins and ten minutes after mobilization is completed | 
| Heart rate | Heart frequency per minute | Ten minutes before mobilization begins and ten minutes after mobilization is completed | 
| Respiratory frequency | Respiratory frequency per minute | Ten minutes before mobilization begins and ten minutes after mobilization is completed |