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

R

Rennes University Hospital

Status

Enrolling

Conditions

Cardiac Surgery

Treatments

Other: Questionnaire including APAIS scale

Study type

Observational

Funder types

Other

Identifiers

NCT06794697
35RC23_3034_ADMITY

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

400 participants in 2 patient groups

Patients admitted the day before their surgery (J-1)
Description:
Patients admitted the day before their cardiac surgery (J-1) will be invited to complete the questionnaire in two stages : upon admission and just before leaving for the operating room
Treatment:
Other: Questionnaire including APAIS scale
Patients admitted on the day of surgery (J-0)
Description:
Patients admitted on the day of cardiac surgery (J-1) will be invited to complete the questionnaire in two stages : upon admission and just before leaving for the operating room
Treatment:
Other: Questionnaire including APAIS scale

Trial contacts and locations

1

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Central trial contact

Erwan FLECHER, MD, PHD; Salomé HINGANT

Data sourced from clinicaltrials.gov

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