Anxiety DisorderERATANCT07034313
Rouen Study on Anxiety
An observational study of Anxiety Disorder, run by University Hospital, Rouen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorder
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2025to 1 Nov 2025
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing skin allergy testing
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rouen Study on Anxiety During Allergy Tests
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.
Read more
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.
Read the 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
- Conditions
- Anxiety Disorder
- Keywords
- allergy test
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient benefiting from allergy tests | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (4)
Prevalence of anxiety disorders
Anxiety-depressive disorders will be assessed using the HAD (Hospital Anxiety and Depression scale) questionnaire, administered to patients included in the study.
Measured: 1 day
Prevalence of anxiety disorders
Anxiety-depressive disorders will be assessed using the PSS (Perceived Stress Scale) questionnaire, administered to patients included in the study.
Measured: 1 day
Patient care pathways
Information on the care pathway will be collected using closed (multiple choice) questions (general information).
Measured: 1 day
Positivity rate of the various allergy tests
The results of the allergy tests will be studied by consulting the clinical file, and will be analyzed for their association with anxiety levels.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start17 Mar 2025
- Primary completion14 May 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien SF FRANCHINA, Doctor, Principal investigator, University Rouen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034313
- Sponsor's protocol ID
- 2024/0241/OB
- Other IDs
- N° IDRCB : 2024-A02144-43
- Acronym
- ERATA
- Status last verified
- Jan 2026
- First submitted
- 13 Jun 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rouen Study on Anxiety During Allergy Tests
- ClinicalTrials.gov ID
- NCT07034313
- Acronym / sponsor ID
- ERATA / 2024/0241/OB
- Conditions
- Anxiety Disorder
- Keywords
- allergy test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient benefiting from allergy tests | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing skin allergy testing
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Prevalence of anxiety disorders
Time frame: 1 day
Prevalence of anxiety disorders
Time frame: 1 day
Patient care pathways
Time frame: 1 day
Positivity rate of the various allergy tests
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastien SF FRANCHINA, Doctor principal investigator
University Rouen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorder, run by University Hospital, Rouen 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 4 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: finished, as of the sponsor's last update on 6 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure anxiety in patients undergoing allergy testing (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2026.