Clinical trial NCT06794697: Evaluation of Preoperative Anxiety Level Based on the Day of Admission for Cardiac Surgery
Official title: Evaluation of Preoperative Anxiety Level Based on the Day of Admission for Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Surgery
Keywords: preoperative anxiety
cardiac surgery
evaluation of anxiety
admission day
APAIS scale
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cardiac pathology requiring cardiac surgery

Brief summary: Prospective, observational, non-randomized study that evaluates the impact of the admission day (J-1 vs J-0) on preoperative anxiety in cardiac surgery patients.

Detailed description: The goal of this study is to determine whether the admission day (J-1 or J-0) has a significant effect on preoperative anxiety using the APAIS (Amsterdam Preoperative Anxiety and Information) scale and to identify modifiable factors to improve patient care.

This study includes 400 patients divided into two groups : 200 patients admitted the day before their surgery (J-1) and 200 patients admitted on the day of surgery (J-0).

Patients admitted for cardiac surgery at the University Hospital of Rennes will be invited to participate after verification of the inclusion criteria. A nurse or surgeon will explain the objectives and procedures of the study and provide the patient with an information and non-opposition letter. If the patient agrees, they will be included in the study, and the non-opposition form will be recorded in their medical file.

Patients will complete the questionnaire in two stages : upon admission and just before leaving for the operating room. The estimated time to complete the questionnaire is approximately 15 minutes, with 10 minutes for the first part and 5 minutes for the second part.

Eligibility criteria: Inclusion Criteria:

* Aged over 18 years old
* Scheduled for cardiac surgery
* Have received written and oral information about the protocol
* Admitted to the cardiac and thoracic surgery units
* Not opposed to participating in the research.

Exclusion Criteria:

* Patient undergoing emergency cardiac surgery with no time for reflection
* Legal adults under legal protection (guardianship, curators, or legal protection)
* Pregnant or breastfeeding women, minors, individuals unable to express consent
* Patient on long-term anxiolytic treatment
* Patient with psychiatric disorders, cognitive impairments, or central neurological disorders.
* Patient already participating in an ongoing study in the department of Thoracic and Cardiovascular Surgery.

Primary outcomes:
measure: Comparison of the level of anxiety before leaving for the operating room between patients arriving the day before the operation and those arriving on the day of the operation.
timeFrame: Day of scale completion
Secondary outcomes:
measure: Comparison of of the level of anxiety at admission and before leaving for the operating room between the 2 groups
timeFrame: Day of scale completion
measure: Comparison of of the level of anxiety at admission and before leaving for the operating room between the 2 groups
timeFrame: Day of scale completion
measure: Comparison of the level of preoperative anxiety before going to the operating room according to patient comfort parameters
timeFrame: Day of scale completion
measure: Comparison of the level of preoperative anxiety before going to the operating room according to patient comfort parameters
timeFrame: Day of scale completion
measure: Comparison of preoperative anxiety according to patient's understanding of the surgery and the type of surgical procedure
timeFrame: Day of scale completion
measure: Comparison of preoperative anxiety according to patient's understanding of the surgery and the type of surgical procedure
timeFrame: Day of scale completion
measure: Comparison of preoperative anxiety according to the surgical schedule
timeFrame: Day of scale completion
measure: Comparison of preoperative anxiety according to the surgical schedule
timeFrame: Day of scale completion
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
Study officials:
References: