AnxietyEVALANXINCT04752423
Nurse Anesthesist Assessment of Patient Preoperative Anxiety
An observational study of Anxiety and Anesthesia, General, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Anesthesia, General
- What is being tested?
- Pre operative assessment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2021to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Anxiety, Anesthesia, General
- Being tested
- Pre operative assessment
- Keywords
- Preoperative anxiety, Concordance, Self-assessment assessment of anxiety, Nurse anesthesist hetero-assessment of anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre operative assessmentOther
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)
| Study group | Role | What they receive |
|---|---|---|
| PATIENT group | Adult patients shedule for general anesthesia Receives: Other: Pre operative assessment | |
| NURSE group | Nurse anesthesist in charge of the corresponding patient Receives: Other: Pre operative assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of preoperative anxiety level expressed by the patient (self-assessment) with that estimated by murse anesthetist (hetero-assessment)
Agreement between patient's Numeric Rating Scale (NRS from 0 to 10) and nurse anesthetist NRS (kappa coefficient)
Measured: Self- and hetero-assessment will be performed peroperatively during the period from arrival in the operating room to the induction of general anesthesia.
Secondary outcomes (4)
Patient anxiety self assessment : NRS (from 0 to 10) versus Amsterdam Preoperative Anxiety and Information (APAIS) scale (from 6 to 30)
correlation between NRS and APAIS scale
Measured: 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)
correlation between NRS and Covi scale
Measured: 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
sub group analysis based on nurse anesthetist professional experience
Measured: Hetero-assessment will be performed preoperatively during the period from arrival in the operating room to induction of general anesthesia.
Anesthesia-related concerns
Comparison between the patient's expression and caregiver's estimate
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start8 Feb 2021
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752423
- Sponsor's protocol ID
- EPP/2020/01
- Acronym
- EVALANXI
- Status last verified
- Aug 2021
- First submitted
- 9 Feb 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient Preoperative Anxiety by Nurse Anesthetist
- ClinicalTrials.gov ID
- NCT04752423
- Acronym / sponsor ID
- EVALANXI / EPP/2020/01
- Conditions
- Anxiety, Anesthesia, General
- Keywords
- Preoperative anxiety, Concordance, Self-assessment assessment of anxiety, Nurse anesthesist hetero-assessment of anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATIENT group | – | Other: Pre operative assessmentAdult patients shedule for general anesthesia |
| NURSE group | – | Other: Pre operative assessmentNurse anesthesist in charge of the corresponding patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre operative assessmentAnxiety assessment : Numeric rating scale (patient and caregiver), APAIS scale (patient), Covi Scale (Caregiver) Verbalization : anesthesia-related concerns (expressed by patient and considered by caregiver) | Other | NURSE group, PATIENT group |
Primary outcome
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)
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Anesthesia, General, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.