- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04752423
Nurse Anesthesist Assessment of Patient Preoperative Anxiety (EVALANXI)
Assessment of Patient Preoperative Anxiety by Nurse Anesthetist
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Besançon, France, 25000
- CHU de Besançon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patient undergoing general anesthesia and the corresponding nurse anesthetist in charge of the patient.
To avoid any learning effect, each nurse can only participate once in the study
Description
Patient Inclusion Criteria:
- Age > 18 years old
- Patients with ASA 1, ASA 2 ou ASA 3
- Patients undergoing planned surgery with general anesthesia
Patient Exclusion Criteria:
- Age <18
- Refusal, inability to oral consent
- Cardio-thoracic surgery or emergency surgery
- Patient with dementia, medically diagnosed psychiatric disorder, inability to answer questions
Nurse anesthetist Inclusion Criteria:
- Nurse anesthesis in charge of the corresponding patient
Nurse anesthetist Exclusion Criteria:
- Assessment of the preoperative anxiety of a previously included patient
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PATIENT group
Adult patients shedule for general anesthesia
|
Anxiety assessment : Numeric rating scale (patient and caregiver), APAIS scale (patient), Covi Scale (Caregiver) Verbalization : anesthesia-related concerns (expressed by patient and considered by caregiver) |
NURSE group
Nurse anesthesist in charge of the corresponding patient
|
Anxiety assessment : Numeric rating scale (patient and caregiver), APAIS scale (patient), Covi Scale (Caregiver) Verbalization : anesthesia-related concerns (expressed by patient and considered by caregiver) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of preoperative anxiety level expressed by the patient (self-assessment) with that estimated by murse anesthetist (hetero-assessment)
Time Frame: Self- and hetero-assessment will be performed peroperatively during the period from arrival in the operating room to the induction of general anesthesia.
|
Agreement between patient's Numeric Rating Scale (NRS from 0 to 10) and nurse anesthetist NRS (kappa coefficient)
|
Self- and hetero-assessment will be performed peroperatively during the period from arrival in the operating room to the induction of general anesthesia.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient anxiety self assessment : NRS (from 0 to 10) versus Amsterdam Preoperative Anxiety and Information (APAIS) scale (from 6 to 30)
Time Frame: Self- and hetero-assessment will be performed preoperatively during the period from arrival in the operating room to induction of general anesthesia.
|
correlation between NRS and APAIS scale
|
Self- and hetero-assessment will be performed preoperatively during the period from arrival in the operating room to induction of general anesthesia.
|
Patient's Anxiety assessment by caregiver : NRS (from 0 to 10) versus Covi scale from 3 to 15) (Lipman & Covi 1976)
Time Frame: Self- and hetero-assessment will be performed preoperatively during the period from arrival in the operating room to induction of general anesthesia.
|
correlation between NRS and Covi scale
|
Self- and hetero-assessment will be performed preoperatively during the period from arrival in the operating room to induction of general anesthesia.
|
Reliability of hetero-assessment performed by caregiver
Time Frame: Hetero-assessment will be performed preoperatively during the period from arrival in the operating room to induction of general anesthesia.
|
sub group analysis based on nurse anesthetist professional experience
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Hetero-assessment will be performed preoperatively during the period from arrival in the operating room to induction of general anesthesia.
|
Anesthesia-related concerns
Time Frame: Anesthesia-related concerns observed by the patient and the corresponding nurse anesthetist will be collected preoperatively from arrival in the operating room to induction of general anesthesia.
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Comparison between the patient's expression and caregiver's estimate
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Anesthesia-related concerns observed by the patient and the corresponding nurse anesthetist will be collected preoperatively from arrival in the operating room to induction of general anesthesia.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPP/2020/01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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