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

NCT06794697 | Recruiting

• 1 other identifier: 35RC23_3034_ADMITY
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery

Keywords

preoperative anxiety; cardiac surgery; evaluation of anxiety; admission day; APAIS scale

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Comparison of of the level of anxiety at admission and before leaving for the operating room between the 2 groups

  Day of scale completion

• Comparison of of the level of anxiety at admission and before leaving for the operating room between the 2 groups

  Day of scale completion

• Comparison of the level of preoperative anxiety before going to the operating room according to patient comfort parameters

  Day of scale completion

• Comparison of the level of preoperative anxiety before going to the operating room according to patient comfort parameters

  Day of scale completion

• Comparison of preoperative anxiety according to patient's understanding of the surgery and the type of surgical procedure

  Day of scale completion

Study Arms (2)

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 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

Interventions

Questionnaire including APAIS scale 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 the day before their surgery (J-1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cardiac pathology requiring cardiac surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Centre Hospitalier Universitaire de Rennes

Rennes, 35033, France

RECRUITING

Central Study Contacts

Salomé HINGANT

CONTACT

(0)6.47.55.66.26; salome.hingant@pfps-churennes.bzh

Erwan FLECHER, MD, PHD

CONTACT

(0)2 99 28 24 16; Erwan.FLECHER@chu-rennes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 27, 2025
• Study Start: November 12, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)