Evaluation of Preoperative Anxiety Level Based on the Day of Admission for Cardiac Surgery

Recruiting

• Conditions: Cardiac Surgery

• Registration Number: NCT06794697
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study Start: 2024-11-12
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-21
• Study First Posted: 2025-01-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Day of scale completion	Amsterdam Preoperative Anxiety and Information Scale (APAIS) - score 1 to 5 (1=not anxious at all ; 5=extremely anxious)

Secondary Outcome Measures

Name	Time	Method
Comparison of of the level of anxiety at admission and before leaving for the operating room between the 2 groups	Day of scale completion	Answers to a questionnaire
Comparison of the level of preoperative anxiety before going to the operating room according to patient comfort parameters	Day of scale completion	Answers to a questionnaire
Comparison of preoperative anxiety according to patient's understanding of the surgery and the type of surgical procedure	Day of scale completion	Answers to a questionnaire
Comparison of preoperative anxiety according to the surgical schedule	Day of scale completion	Answers to a questionnaire

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Rennes; 🇫🇷 Rennes, France