The Effect of Music on Procedural Distress During Mobilization in Intensive Care Unit Patients: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Universiteit Antwerpen
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- pain perception level
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, 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Music
Music through noise cancelling headphones.
Intervention: Music (Device)
No music
Control group receiving regular care. No music will be offered to the patient.
Outcomes
Primary Outcomes
pain perception 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 pain level
stress perception 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.
anxiety perception 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.
Secondary Outcomes
- Time of mobilization(Ten minutes before mobilization begins and ten minutes after mobilization is completed)
- Respiratory frequency(Ten minutes before mobilization begins and ten minutes after mobilization is completed)
- Blood pressure(Ten minutes before mobilization begins and ten minutes after mobilization is completed)
- Heart rate(Ten minutes before mobilization begins and ten minutes after mobilization is completed)
Investigators
Filip Haegdorens
Assistant professor
Universiteit Antwerpen