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Clinical Trials/NCT04752423
NCT04752423
Completed
Not Applicable

Assessment of Patient Preoperative Anxiety by Nurse Anesthetist

Centre Hospitalier Universitaire de Besancon1 site in 1 country40 target enrollmentFebruary 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Centre Hospitalier Universitaire de Besancon
Enrollment
40
Locations
1
Primary Endpoint
Comparison of preoperative anxiety level expressed by the patient (self-assessment) with that estimated by murse anesthetist (hetero-assessment)
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

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).

Registry
clinicaltrials.gov
Start Date
February 8, 2021
End Date
July 31, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age \> 18 years old
  • Patients with ASA 1, ASA 2 ou ASA 3
  • Patients undergoing planned surgery with general anesthesia

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Patient's Anxiety assessment by caregiver : NRS (from 0 to 10) versus Covi scale from 3 to 15) (Lipman & Covi 1976)(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(Hetero-assessment will be performed preoperatively during the period from arrival in the operating room to induction of general anesthesia.)
  • Anesthesia-related concerns(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.)
  • Patient anxiety self assessment : NRS (from 0 to 10) versus Amsterdam Preoperative Anxiety and Information (APAIS) scale (from 6 to 30)(Self- and hetero-assessment will be performed preoperatively during the period from arrival in the operating room to induction of general anesthesia.)

Study Sites (1)

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