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

NCT ID: NCT06794697

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-12

Study Completion Date

2026-05-31

Brief Summary

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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

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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.

Conditions

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Cardiac Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients admitted the day before their surgery (J-1)

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

Questionnaire including APAIS scale

Intervention Type OTHER

Patients will complete a questionnaire in two stages : upon admission and just before leaving for the operating room

Patients admitted on the day of surgery (J-0)

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

Questionnaire including APAIS scale

Intervention Type OTHER

Patients will complete a questionnaire in two stages : upon admission and just before leaving for the operating room

Interventions

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Questionnaire including APAIS scale

Patients will complete a questionnaire in two stages : upon admission and just before leaving for the operating room

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Universitaire de Rennes

Rennes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Salomé HINGANT

Role: CONTACT

(0)6.47.55.66.26

Erwan FLECHER, MD, PHD

Role: CONTACT

(0)2 99 28 24 16

Facility Contacts

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Salomé HINGANT

Role: primary

(0)6.47.55.66.26

Other Identifiers

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35RC23_3034_ADMITY

Identifier Type: -

Identifier Source: org_study_id

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