Status:
COMPLETED
Music for Anxiety in Critically Ill Patients
Lead Sponsor:
Erasmus Medical Center
Conditions:
Anxiety
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rationale: Anxiety is common in critically ill patients, and has likely become more prevalent in the recent decade due to the imperative of the recent PADIS guidelines to use low levels of sedation an...
Eligibility Criteria
Inclusion
- Patient is hemodynamically stable and communicable (RASS of -2 or higher in the 24h before intended inclusion: meaning patient is at least briefly awakened with eye contact to voice).
- Expected ICU stay upon randomisation of at least another 48 hours.
- Written informed consent acquired from the patient or legal representative.
Exclusion
- Patients with severe hearing impairment, defined as no verbal communication possible.
- Neurological condition (e.g. severe stroke), when deemed to interfere with processing of music (e.g. not applicable to patients with minor stroke in past medical history without significant residual neurological deficits; those patients could be included).
- Insufficient knowledge of the Dutch or English language for informed consent.
- Participation in another study that may possibly intervene with the primary outcome measure
Key Trial Info
Start Date :
August 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04796389
Start Date
August 24 2020
End Date
December 1 2021
Last Update
April 13 2022
Active Locations (3)
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1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 GD
2
Ikazia
Rotterdam, South Holland, Netherlands, 3083 AN
3
HagaZiekenhuis
The Hague, South Holland, Netherlands, 2545 AA