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
• Conditions: Anxiety; Anesthesia, General
• Intervention / Treatment: Other: Pre operative assessment

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

Study Locations

• France
  • Besançon, France, 25000
    • CHU de Besançon

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PATIENT group; Adult patients shedule for general anesthesia	Other: Pre operative assessment; 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	Other: Pre operative assessment; 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)	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)	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)	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	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	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

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

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

• Keywords: Concordance; Preoperative anxiety; Self-assessment assessment of anxiety; Nurse anesthesist hetero-assessment of anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: EPP/2020/01

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