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Rouen Study on Anxiety

Rouen Study on Anxiety During Allergy Tests

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07034313
Acronym
ERATA
Enrollment
300
Registered
2025-06-24
Start date
2025-03-17
Completion date
2025-11-01
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorder

Keywords

allergy test

Brief summary

Allergy testing is necessary to confirm a diagnosis of allergy, whether food, respiratory, drug, or hymenoptera venom. Although the vast majority of these tests are well tolerated, performing them carries a very low risk of inducing an allergic reaction in the patient, warranting continuous medical monitoring regardless of the allergy being investigated. A severe reaction can be observed, largely during oral or intravenous reintroduction tests, in up to 15% of series for food allergies, and even less for drug allergies. The perceived risk can vary between patients, and this subjective perception can be influenced by several factors, including personal experience, medical history, or access to information regarding allergy testing. Anxiety related to allergy testing can influence patient experience, but also test results.

Detailed description

The assessment of this anxiety and understanding of the factors that influence it remain understudied, particularly in patients undergoing allergy testing. This study seeks to measure this anxiety and the factors that may influence it, in order to tailor personalized care for each patient. This study will be conducted through the administration of a standardized questionnaire designed to measure the anxiety of patients undergoing allergy testing, as well as several parameters that may influence this anxiety, such as the prevalence of depression and anxiety disorders, and personality traits influenced by stress, using specific and validated scores. This questionnaire will be administered to patients attending Rouen University Hospital for skin allergy testing and oral or intravenous provocation testing. This descriptive study will focus on analyzing patients' perceptions and experiences without directly interfering with the medical procedures performed. Patients' perceptions and experiences will be collected using statements that will be rated on a Likert scale by the patients

Interventions

None listed

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult (over 18 years old), of both sexes. * Patient undergoing allergy testing (provocation or skin prick tests) at the Erik Satie Center during the inclusion period. * Patient affiliated with a social security scheme * Patient who has read and understood the information letter and does not object to participating in the study

Exclusion criteria

* Patient under guardianship or curatorship. * Patient suffering from a psychological or sensory abnormality likely to prevent the patient from fully understanding the conditions required for participation in the study or to prevent the patient from giving informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Measure anxiety in patients undergoing allergy testing1 dayThe primary endpoint will be the visual analogue anxiety scale with a score ranging from 0 (total absence of anxiety) to 10 (maximum anxiety), before allergy testing is performed.

Secondary

MeasureTime frameDescription
Prevalence of anxiety disorders1 dayAnxiety-depressive disorders will be assessed using the HAD (Hospital Anxiety and Depression scale) questionnaire, administered to patients included in the study.
Patient care pathways1 dayInformation on the care pathway will be collected using closed (multiple choice) questions (general information).
Positivity rate of the various allergy tests1 dayThe results of the allergy tests will be studied by consulting the clinical file, and will be analyzed for their association with anxiety levels.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORSebastien SF FRANCHINA, Doctor

University Rouen Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026