Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Nurse Anesthesist Assessment of Patient Preoperative Anxiety (EVALANXI)

19. august 2021 opdateret af: Centre Hospitalier Universitaire de Besancon

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

40

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Besançon, Frankrig, 25000
        • CHU de Besancon

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
PATIENT group
Adult patients shedule for general anesthesia
Andet: 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
Andet: 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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of preoperative anxiety level expressed by the patient (self-assessment) with that estimated by murse anesthetist (hetero-assessment)
Tidsramme: 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)
Self- and hetero-assessment will be performed peroperatively during the period from arrival in the operating room to the induction of general anesthesia.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient anxiety self assessment : NRS (from 0 to 10) versus Amsterdam Preoperative Anxiety and Information (APAIS) scale (from 6 to 30)
Tidsramme: 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
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)
Tidsramme: 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
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
Tidsramme: 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
Hetero-assessment will be performed preoperatively during the period from arrival in the operating room to induction of general anesthesia.
Anesthesia-related concerns
Tidsramme: 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
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire de Besancon

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. februar 2021

Primær færdiggørelse (Faktiske)

31. juli 2021

Studieafslutning (Faktiske)

31. juli 2021

Datoer for studieregistrering

Først indsendt

9. februar 2021

Først indsendt, der opfyldte QC-kriterier

9. februar 2021

Først opslået (Faktiske)

12. februar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EPP/2020/01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Pre operative assessment

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Philippines

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner