Cardiac SurgeryADMITYNCT06794697
Evaluation of Preoperative Anxiety Level Based on the Day of Admission for Cardiac Surgery
An observational study of Cardiac Surgery, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Questionnaire including APAIS scale
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2024to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cardiac pathology requiring cardiac surgery
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Rennes
Rennes, 35033
Salomé HINGANT, (0)6.47.55.66.26, salome.hingant@pfps-churennes.bzh
About this study
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.
Read the 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.
- Conditions
- Cardiac Surgery
- Being tested
- Questionnaire including APAIS scale
- Keywords
- preoperative anxiety, cardiac surgery, evaluation of anxiety, admission day, APAIS scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire including APAIS scaleOther
Patients will complete a questionnaire in two stages : upon admission and just before leaving for the operating room
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Questionnaire including APAIS scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Amsterdam Preoperative Anxiety and Information Scale (APAIS) - score 1 to 5 (1=not anxious at all ; 5=extremely anxious)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: Day of scale completion
Comparison of preoperative anxiety according to the surgical schedule
Answers to a questionnaire
Measured: Day of scale completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start12 Nov 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794697
- Sponsor's protocol ID
- 35RC23_3034_ADMITY
- Acronym
- ADMITY
- Status last verified
- Aug 2026
- First submitted
- 6 Jan 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Preoperative Anxiety Level Based on the Day of Admission for Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06794697
- Acronym / sponsor ID
- ADMITY / 35RC23_3034_ADMITY
- Conditions
- Cardiac Surgery
- Keywords
- preoperative anxiety, cardiac surgery, evaluation of anxiety, admission day, APAIS scale
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients admitted the day before their surgery (J-1) | – | Other: Questionnaire including APAIS scalePatients 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 |
| Patients admitted on the day of surgery (J-0) | – | Other: Questionnaire including APAIS scalePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cardiac pathology requiring cardiac surgery
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire including APAIS scalePatients will complete a questionnaire in two stages : upon admission and just before leaving for the operating room | Other | Patients admitted on the day of surgery (J-0), Patients admitted the day before their surgery (J-1) |
Primary outcome
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)
8 secondary outcomes
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
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
Comparison of the level of preoperative anxiety before going to the operating room according to patient comfort parameters
Time frame: Day of scale completion
Comparison of the level of preoperative anxiety before going to the operating room according to patient comfort parameters
Time frame: Day of scale completion
Comparison of preoperative anxiety according to patient's understanding of the surgery and the type of surgical procedure
Time frame: Day of scale completion
Comparison of preoperative anxiety according to patient's understanding of the surgery and the type of surgical procedure
Time frame: Day of scale completion
Comparison of preoperative anxiety according to the surgical schedule
Time frame: Day of scale completion
Comparison of preoperative anxiety according to the surgical schedule
Time frame: Day of scale completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salomé HINGANT ((0)6.47.55.66.26, salome.hingant@pfps-churennes.bzh), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.