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Clinical Trials/NCT07034313
NCT07034313CompletedNot Applicable

Rouen Study on Anxiety During Allergy Tests

University Hospital, Rouen2 sites in 1 country300 target enrollmentStarted: March 17, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
300
Locations
2
Primary Endpoint
Measure anxiety in patients undergoing allergy testing

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

Patient benefiting from allergy tests

Outcomes

Primary Outcomes

Measure anxiety in patients undergoing allergy testing

Time Frame: 1 day

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.

Secondary Outcomes

  • Prevalence of anxiety disorders(1 day)
  • Patient care pathways(1 day)
  • Positivity rate of the various allergy tests(1 day)

Investigators

Sponsor
University Hospital, Rouen
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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