Nurse Anesthesist Assessment of Patient Preoperative Anxiety

Anxiety Clinical Trial

— EVALANXI  

Official title:

Assessment of Patient Preoperative Anxiety by Nurse Anesthetist

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752423
• Other study ID #: EPP/2020/01
• Status: Completed
• Start date: February 8, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General
• Anxiety
• Anxiety Disorders

Intervention

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)

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.