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AnxietyDECIDINHNCT05364801

Impact of Anxiety on the Decision-making Processes of Anesthesiologists

An observational study of Anxiety and Decision Making, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Except for exaggerated situations in which aspiration risk seems obvious (or absent), the choice of a rapid sequence induction protocol for general anesthesia is often made under uncertainty, according to the individual assessment of the balance between the aspiration risk on one hand and the anaphylaxis risk induced… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Anxiety, Decision Making, General Anesthesia
What is being tested?
Survey
How many people
500 participants
Where
1 siteFrance
Study dates
2 May 2022to 31 Oct 2024
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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: A first phase will include all anesthesiologists of Bourgogne-Franche-Comté and Grand-Est regions (500 subjects) A second phase will include all anesthesiologists registered in France.

Who may be able to join

  • all anesthesiologists who have completed their PhD
  • working in France
  • in a public or private healthcare facility

Who cannot join

  • residents
  • retired anesthesiologists

Trial locations and contacts

1 site in 1 country.

David FERREIRA, PH contact

+33 3 81 66 91 31

dferreira@chu-besancon.fr

Chloé ZANONI, resident contact

+33 6 42 56 14 86

chloe.zanoni@gmail.com

France1 site, 1 recruiting

  • CHU Besançon

    Besançon, Doubs, 25000

    David FERREIRA, MD, +333 81 66 91 31, dferreira@chu-besancon.fr

    Recruiting

Other trials in France

About this study

Official title: Impact of Anxiety on the Decision-making Process of Anesthesiologists in the Choice of Drugs for Induction of General Anesthesia of Patients With Aspiration Risk Factors

Except for exaggerated situations in which aspiration risk seems obvious (or absent), the choice of a rapid sequence induction protocol for general anesthesia is often made under uncertainty, according to the individual assessment of the balance between the aspiration risk on one hand and the anaphylaxis risk induced by short-acting curares on the other hand.

The impact of anxiety and impulsivity on the choice of induction protocols under uncertainty has never been studied before.

Read more

In order to investigate this issue, an online anonymous survey has been designed and will be sent to the anesthesiologists of the Bourgogne Franche-Comté and Grand Est regions in France.

The primary objective of this study is to assess the impact of trait-anxiety using the STAI-Y2 form on the decision-making process of anesthesiologists during the choice of an induction protocol for patients at risk of aspiration.

The secondary objectives are to characterize decision-making profiles, to measure the implicit dimension of anxiety using an Implicit association test, to study the impact of impulsivity on decision-making processes under uncertainty using the short version of UPPS-P scale and to study the role of socio-demographic data and professional history in these decisions.

Being tested
Survey
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurveyOther

    Online anonymous survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. State-Trait Anxiety Inventory Form Y2

    Measure of STAI Y2. A score above the threshold of 49 out of 80 will display a trait-anxiety interfering with the decision-making of the anesthesiologists.

    Measured: at 4 months

Secondary outcomes (4)

  1. Decision-making profiles

    Characterize decision-making profiles using a survey of 10 clinical situations presenting a variable degree of uncertainty, for which a risk score (RS) has been determined by an expert committee. For each situation, the induction protocol must be chosen among a five-choice list gathered in 3 categories : (1) rapid sequence induction (hypnotic + short-acting curare), (2) short protocol (hypnotic + alfentanil or remifentanil) and (3) standard (hypnotic + sufentanil or remifentanil + cisatracurium). Each category has its own score, so that a protocol score (PS) is attributed to the chosen protocol. Finally, a global score (GS) is calculated for each subject by adding the product of RS x PS of the 10 situations.

    The subjects will be attributed to one of the three profiles according to their global score.

    Measured: at 4 months

  2. Implicit measure of anxiety

    Measure of the anxiety using the Implicit association test.

    Measured: at 4 months

  3. Impulsivity measure : (negative) Urgency, (lack of) Premeditation, (lack of) Perseverance, Sensation (seeking) - Positive (urgency) scale (UPPS-P scale)

    Measure of the impulsivity using the short version of the UPPS-P scale which is the (negative) Urgency, (lack of) Premeditation, (lack of) Perseverance, Sensation (seeking) - Positive (urgency) scale.

    This scale measures five dimensions of impulsivity. Each dimension will be scored and compared to the mean and standard deviation of the other profiles and to the mean and standard deviation of the general population.

    A score above the mean of the general population shows a higher tendency to impulsive behaviours in the scored dimension. The higher the scores are, the more impulsive the subjects are.

    Standard values for each dimension :

    Dimensions Mean Standard deviation Negative Urgency 9.38 2.73 Positive Urgency 10.84 2.38 Lack of premeditation 7.98 2.15 Lack of perseverance 7.46 2.41 Sensation seeking 10.55 2.72

    Measured: at 4 months

  4. Socio-demographics and professional history

    Collection of socio-demographic data : sex, experience, practice in anaesthesic wards where aspiration risk is frequently encountered (digestive OR, emergency OR, obstetrics), region, practice in a public or private facility, time spent on duty (hours per week), coffee and cigarette consumption at work, history of severe anaphylaxis resulting from a rapid sequence induction, history of aspiration resulting from an induction of general anesthesia, emotional issues of severe anaphylaxis or aspiration.

    Measured: at 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2022
  2. Study start2 May 2022
  3. Primary completion31 May 2024 (estimated)
  4. Study completion31 Oct 2024 (estimated)

Resources

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
Cross-sectional
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05364801
Sponsor's protocol ID
2022/683
Acronym
DECIDINH
Status last verified
Oct 2023
First submitted
3 May 2022
Last updated
9 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data will be strictly anonymous.

Publications

  • Stiegler MP, Tung A. Cognitive processes in anesthesiology decision making. Anesthesiology. 2014 Jan;120(1):204-17. doi: 10.1097/ALN.0000000000000073.

    PubMed 24212195

  • Croskerry P. The importance of cognitive errors in diagnosis and strategies to minimize them. Acad Med. 2003 Aug;78(8):775-80. doi: 10.1097/00001888-200308000-00003.

    PubMed 12915363

  • Blumenthal-Barby JS, Krieger H. Cognitive biases and heuristics in medical decision making: a critical review using a systematic search strategy. Med Decis Making. 2015 May;35(4):539-57. doi: 10.1177/0272989X14547740. Epub 2014 Aug 21.

    PubMed 25145577

  • Tversky A, Kahneman D. Judgment under Uncertainty: Heuristics and Biases. Science. 1974 Sep 27;185(4157):1124-31. doi: 10.1126/science.185.4157.1124.

    PubMed 17835457

  • Heine MF, Lake CL. Nature and prevention of errors in anesthesiology. J Surg Oncol. 2004 Dec 1;88(3):143-52. doi: 10.1002/jso.20124. No abstract available.

    PubMed 15562456

  • Croskerry P, Abbass A, Wu AW. Emotional influences in patient safety. J Patient Saf. 2010 Dec;6(4):199-205. doi: 10.1097/pts.0b013e3181f6c01a.

    PubMed 21500605

  • Kozlowski D, Hutchinson M, Hurley J, Rowley J, Sutherland J. The role of emotion in clinical decision making: an integrative literature review. BMC Med Educ. 2017 Dec 15;17(1):255. doi: 10.1186/s12909-017-1089-7.

    PubMed 29246213

  • Heyhoe J, Birks Y, Harrison R, O'Hara JK, Cracknell A, Lawton R. The role of emotion in patient safety: Are we brave enough to scratch beneath the surface? J R Soc Med. 2016 Feb;109(2):52-8. doi: 10.1177/0141076815620614. Epub 2015 Dec 18.

    PubMed 26682568

  • Bommer C, Sullivan S, Campbell K, Ahola Z, Agarwal S, O'Rourke A, Jung HS, Gibson A, Leverson G, Liepert AE. Pre-simulation orientation for medical trainees: An approach to decrease anxiety and improve confidence and performance. Am J Surg. 2018 Feb;215(2):266-271. doi: 10.1016/j.amjsurg.2017.09.038. Epub 2017 Nov 10.

    PubMed 29174166

  • Yerkes RM, Dodson JD. The relation of strength of stimulus to rapidity of habit-formation. J Comp Neurol Psychol. 1908;18(5):459-482.

  • Liu G, Chimowitz H, Isbell LM. Affective influences on clinical reasoning and diagnosis: insights from social psychology and new research opportunities. Diagnosis (Berl). 2022 Jan 4;9(3):295-305. doi: 10.1515/dx-2021-0115. eCollection 2022 Aug 1.

    PubMed 34981701

  • Burgess DJ. Are providers more likely to contribute to healthcare disparities under high levels of cognitive load? How features of the healthcare setting may lead to biases in medical decision making. Med Decis Making. 2010 Mar-Apr;30(2):246-57. doi: 10.1177/0272989X09341751. Epub 2009 Sep 2.

    PubMed 19726783

  • Mosier KL, Fischer UM. Judgment and Decision Making by Individuals and Teams: Issues, Models, and Applications. Rev Hum Factors Ergon. 2010;6(1):198-256.

  • Djulbegovic B, Hozo I, Schwartz A, McMasters KM. Acceptable regret in medical decision making. Med Hypotheses. 1999 Sep;53(3):253-9. doi: 10.1054/mehy.1998.0020.

    PubMed 10580533

  • Allen TJ, Moeller FG, Rhoades HM, Cherek DR. Impulsivity and history of drug dependence. Drug Alcohol Depend. 1998 Apr 1;50(2):137-45. doi: 10.1016/s0376-8716(98)00023-4.

    PubMed 9649965

Questions about this trial

What is this clinical trial studying?

An observational study of Anxiety and Decision Making, 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?

The sponsor lists 3 inclusion and 2 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 9 Feb 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact David FERREIRA, PH (+33 3 81 66 91 31, dferreira@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

State-Trait Anxiety Inventory Form Y2 (time frame: at 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05364801, which also lists 40 linked publications.

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 9 Feb 2024.

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