Nurse Anesthesist Assessment of Patient Preoperative Anxiety (EVALANXI)

Assessment of Patient Preoperative Anxiety by Nurse Anesthetist

Preoperative anxiety is a major concern for patients who undergo surgery. To accurately identify anxious patient is therefore crucial to improve perioperative patient care. Preoperative anxiety remain highly difficult to quantify in current practice. Many patient fail to express their anxiety and the assessment of the level of anxiety is mainly based on heteroevaluation by caregivers. Nurse anesthetists provide closed support to patient prior to the induction of anesthesia. The aim of the study is to assess whether nurse anesthetist accurately assess patient preoperative anxiety from arrival to the operating room to the induction of anesthesia.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

EVALANXI is a single-center prospective observational study. The main objective of the study is to assess whether the assessment of preoperative anxiety by nurse anesthetist (hetero-assessment) accurately estimate the level of anxiety reported by the patient from arrival to the operating room to the induction of anesthesia (self-assessment).

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Besançon, France, 25000
        • CHU de Besançon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
Comparison between the patient's expression and caregiver's estimate
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2021

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 9, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Actual)

August 20, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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