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Completed

NCT Number: NCT07034313

Rouen Study on Anxiety

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Allergologie

Rouen, 76031, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Prevalence of anxiety disorders

    Time frame: 1 day

    Anxiety-depressive disorders will be assessed using the HAD (Hospital Anxiety and Depression scale) questionnaire, administered to patients included in the study.

  2. Prevalence of anxiety disorders

    Time frame: 1 day

    Anxiety-depressive disorders will be assessed using the PSS (Perceived Stress Scale) questionnaire, administered to patients included in the study.

  3. Patient care pathways

    Time frame: 1 day

    Information on the care pathway will be collected using closed (multiple choice) questions (general information).

  4. Positivity rate of the various allergy tests

    Time frame: 1 day

    The results of the allergy tests will be studied by consulting the clinical file, and will be analyzed for their association with anxiety levels.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Rouen Study on Anxiety During Allergy Tests

Acronym: ERATA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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