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NCT Number: NCT06794697

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Rennes

Rennes, 35033, France

Location status: Recruiting

Location contact

Salomé HINGANT

CONTACT

[email protected]

(0)6.47.55.66.26

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire including APAIS scale

Other

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

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.

    Time frame: Day of scale completion

    Amsterdam Preoperative Anxiety and Information Scale (APAIS) - score 1 to 5 (1=not anxious at all ; 5=extremely anxious)

Secondary outcomes

  1. 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

    Amsterdam Preoperative Anxiety and Information Scale (APAIS) - score 1 to 5 (1=not anxious at all ; 5=extremely anxious)

  2. 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

    Answers to a questionnaire

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

    Time frame: Day of scale completion

    Amsterdam Preoperative Anxiety and Information Scale (APAIS) - score 1 to 5 (1=not anxious at all ; 5=extremely anxious)

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

    Time frame: Day of scale completion

    Answers to a questionnaire

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

    Time frame: Day of scale completion

    Amsterdam Preoperative Anxiety and Information Scale (APAIS) - score 1 to 5 (1=not anxious at all ; 5=extremely anxious)

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

    Time frame: Day of scale completion

    Answers to a questionnaire

  7. Comparison of preoperative anxiety according to the surgical schedule

    Time frame: Day of scale completion

    Amsterdam Preoperative Anxiety and Information Scale (APAIS) - score 1 to 5 (1=not anxious at all ; 5=extremely anxious)

  8. Comparison of preoperative anxiety according to the surgical schedule

    Time frame: Day of scale completion

    Answers to a questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Erwan FLECHER, MD, PHD

CONTACT

[email protected]

(0)2 99 28 24 16

Salomé HINGANT

CONTACT

[email protected]

(0)6.47.55.66.26

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: ADMITY

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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