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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery
• Intervention / Treatment: Other: Questionnaire including APAIS scale

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Salomé HINGANT; Phone Number: (0)6.47.55.66.26; Email: salome.hingant@pfps-churennes.bzh
• Study Contact Backup: Name: Erwan FLECHER, MD, PHD; Phone Number: (0)2 99 28 24 16; Email: Erwan.FLECHER@chu-rennes.fr

Study Locations

• France
  • Rennes, France, 35033
    • Recruiting
    • Centre Hospitalier Universitaire de Rennes
    • Contact: Salomé HINGANT; Phone Number: (0)6.47.55.66.26; Email: salome.hingant@pfps-churennes.bzh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with cardiac pathology requiring cardiac surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Questionnaire including APAIS scale; 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	Other: Questionnaire including APAIS scale; Patients will complete a questionnaire in two stages : upon admission and just before leaving for the operating room

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of of the level of anxiety at admission and before leaving for the operating room between the 2 groups	Amsterdam Preoperative Anxiety and Information Scale (APAIS) - score 1 to 5 (1=not anxious at all ; 5=extremely anxious)	Day of scale completion
Comparison of of the level of anxiety at admission and before leaving for the operating room between the 2 groups	Answers to a questionnaire	Day of scale completion
Comparison of the level of preoperative anxiety before going to the operating room according to patient comfort parameters	Amsterdam Preoperative Anxiety and Information Scale (APAIS) - score 1 to 5 (1=not anxious at all ; 5=extremely anxious)	Day of scale completion
Comparison of the level of preoperative anxiety before going to the operating room according to patient comfort parameters	Answers to a questionnaire	Day of scale completion
Comparison of preoperative anxiety according to patient's understanding of the surgery and the type of surgical procedure	Amsterdam Preoperative Anxiety and Information Scale (APAIS) - score 1 to 5 (1=not anxious at all ; 5=extremely anxious)	Day of scale completion
Comparison of preoperative anxiety according to patient's understanding of the surgery and the type of surgical procedure	Answers to a questionnaire	Day of scale completion
Comparison of preoperative anxiety according to the surgical schedule	Amsterdam Preoperative Anxiety and Information Scale (APAIS) - score 1 to 5 (1=not anxious at all ; 5=extremely anxious)	Day of scale completion
Comparison of preoperative anxiety according to the surgical schedule	Answers to a questionnaire	Day of scale completion

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: cardiac surgery; preoperative anxiety; evaluation of anxiety; admission day; APAIS scale
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 35RC23_3034_ADMITY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No