- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04752423
Nurse Anesthesist Assessment of Patient Preoperative Anxiety (EVALANXI)
Assessment of Patient Preoperative Anxiety by Nurse Anesthetist
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Besançon, Frankrike, 25000
- CHu de Besançon
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
PATIENT group
Adult patients shedule for general anesthesia
|
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
|
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) |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Comparison of preoperative anxiety level expressed by the patient (self-assessment) with that estimated by murse anesthetist (hetero-assessment)
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Patient anxiety self assessment : NRS (from 0 to 10) versus Amsterdam Preoperative Anxiety and Information (APAIS) scale (from 6 to 30)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EPP/2020/01
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