The Effect of Music on Procedural Distress During Mobilization in Intensive Care Unit Patients: A Randomized Controlled Trial
MUSICU
1 other identifier
interventional
128
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Feb 2024
Typical duration for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2023
CompletedFirst Posted
Study publicly available on registry
December 18, 2023
CompletedStudy Start
First participant enrolled
February 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedJuly 3, 2024
July 1, 2024
1.3 years
December 8, 2023
July 1, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
Time of mobilization
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
Respiratory frequency
Ten minutes before mobilization begins and ten minutes after mobilization is completed
Study Arms (2)
Music
EXPERIMENTALMusic through noise cancelling headphones.
No music
NO INTERVENTIONControl group receiving regular care. No music will be offered to the patient.
Interventions
The patient can decide the music genre (a standard playlist) and receives a noise-cancelling headphone playing the chosen music during mobilization.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Antwerp
Wilrijk, Antwerp, 2610, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
December 8, 2023
First Posted
December 18, 2023
Study Start
February 2, 2024
Primary Completion
May 31, 2025
Study Completion
May 31, 2025
Last Updated
July 3, 2024
Record last verified: 2024-07