EVALANXI: Nurse Anesthesist Assessment of Patient Preoperative Anxiety

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Completed
CT.gov ID
NCT04752423
Collaborator
(none)
40
1
5.7
7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Assessment of Patient Preoperative Anxiety by Nurse Anesthetist
Actual Study Start Date :
Feb 8, 2021
Actual Primary Completion Date :
Jul 31, 2021
Actual Study Completion Date :
Jul 31, 2021

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Comparison of preoperative anxiety level expressed by the patient (self-assessment) with that estimated by murse anesthetist (hetero-assessment) [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 Outcome Measures

  1. 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.]

    correlation between NRS and APAIS scale

  2. 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.]

    correlation between NRS and Covi scale

  3. 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.]

    sub group analysis based on nurse anesthetist professional experience

  4. 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.]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Besançon Besançon France 25000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT04752423
Other Study ID Numbers:
  • EPP/2020/01
First Posted:
Feb 12, 2021
Last Update Posted:
Aug 20, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Besancon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 20, 2021