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Recruiting NCT06794697

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

Observational Cardiac Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire including APAIS scale.
Who it may be relevant to
Registry conditions: Cardiac Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Questionnaire including APAIS scale
    Patients will complete a questionnaire in two stages : upon admission and just before leaving for the operating room

Primary outcome measures

  • 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. [Time frame: Day of scale completion]
Secondary outcome measures (8)
  • Comparison of of the level of anxiety at admission and before leaving for the operating room between the 2 groups [Time frame: Day of scale completion]
  • Comparison of of the level of anxiety at admission and before leaving for the operating room between the 2 groups [Time frame: Day of scale completion]
  • Comparison of the level of preoperative anxiety before going to the operating room according to patient comfort parameters [Time frame: Day of scale completion]
  • Comparison of the level of preoperative anxiety before going to the operating room according to patient comfort parameters [Time frame: Day of scale completion]
  • Comparison of preoperative anxiety according to patient's understanding of the surgery and the type of surgical procedure [Time frame: Day of scale completion]
  • Comparison of preoperative anxiety according to patient's understanding of the surgery and the type of surgical procedure [Time frame: Day of scale completion]
  • Comparison of preoperative anxiety according to the surgical schedule [Time frame: Day of scale completion]
  • Comparison of preoperative anxiety according to the surgical schedule [Time frame: Day of scale completion]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Centre Hospitalier Universitaire de Rennes — Rennes

Identifiers

NCT: NCT06794697 · 35RC23_3034_ADMITY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗