Rouen Study on Anxiety

NCT07034313 | Recruiting

• 2 other identifiers: 2024/0241/OBN° IDRCB : 2024-A02144-43
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorder

Keywords

allergy test

Outcome Measures

Primary Outcomes (1)

• Measure anxiety in patients undergoing allergy testing

  The 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.

  1 day

Secondary Outcomes (4)

• Prevalence of anxiety disorders

  1 day

• Prevalence of anxiety disorders

  1 day

• Patient care pathways

  1 day

• Positivity rate of the various allergy tests

  1 day

Study Arms (1)

Patient benefiting from allergy tests

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing skin allergy testing

You may qualify if:

• Adult (over 18 years old), of both sexes.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Service d'Allergologie

Rouen, 76031, France

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sebastien SF FRANCHINA, Doctor

  University Rouen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David DM MALLET, Director

CONTACT

02 32 88 82 65; David.Mallet@chu-rouen.fr

Vincent VF FERRANTI, ARC

CONTACT

02 32 88 82 65; Vincent.Ferranti@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: March 17, 2025
• Primary Completion: September 17, 2025
• Study Completion: March 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)