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NCT Number: NCT04752423

Nurse Anesthesist Assessment of Patient Preoperative Anxiety

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.

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Key information

Conditions

Anxiety Anesthesia, General Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Besançon

Besançon, 25000, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre operative assessment

Other

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)

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

Assessment of Patient Preoperative Anxiety by Nurse Anesthetist

Acronym: EVALANXI

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 12, 2021
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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