Status:
COMPLETED
The Feasibility and Acceptability of a Music Intervention to Reduce Preoperative Anxiety in Older Patients
Lead Sponsor:
KU Leuven
Conditions:
Preoperative Care
Preoperative Anxiety
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
The goal of this clinical feasibility study is to learn about the acceptability and feasibility of a music intervention in older patients undergoing cardiac surgery and Transcatheter Aortic Valve Impl...
Detailed Description
Background: High levels of preoperative anxiety (PA) have been associated with several complications, including hemodynamic instability, increased intraoperative requirements for anaesthetics, increas...
Eligibility Criteria
Inclusion
- Patients being 60 years or older, scheduled for elective cardiac surgery and Transcatheter Aortic Valve Implantation (TAVI);
- being capable and willing to participate in the study.
Exclusion
- cannot use headphones;
- have a history of music-induced seizures;
- have deafness or severe ear diseases such as acute otitis media, eardrum rupture, tinnitus, ear infections, etc.;
- admitted on the day of cardiac surgery;
- have an expected hospital stay of less than 24 hours or a planned intensive care unit stay postoperatively for longer than one day;
- have severe postoperative complications and are unable to be interviewed;
- are currently diagnosed with major psychiatric disease (such as, major depression, generalized anxiety disorder) and dementia as identified in the history of patients file;
- have pre-operative delirium
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2024
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06173674
Start Date
December 4 2023
End Date
April 15 2024
Last Update
August 22 2024
Active Locations (1)
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1
University Hospital Leuven
Leuven, Vlaams Brabant, Belgium, 3000