Unexpected AnxietyUSIANCT07246746
Use of an Infotainment System in MRI in Patients Suffering From Unexpected Anxiety.
A study testing Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire and Anxiety support procedure according to randomization: Innovision© or Hypnosis in people with Unexpected Anxiety, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
MRI scans are now considered essential for diagnosing or monitoring disease, and as a result, the number of MRI scans has increased significantly in recent years. Nevertheless, these routine examinations remain a source of apprehension and anxiety for some people. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unexpected Anxiety
- What is being tested?
- Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire and Anxiety support procedure according to randomization: Innovision© or Hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Individuals who have given their verbal consent
- Individuals over the age of 18
- Hospitalized or ambulatory individuals who are able-bodied and scheduled to undergo a brain MRI scan on the 1.5T A MRI machine at the Dijon University Hospital.
- Individuals reporting anxiety about brain MRI for the first time upon admission by the radiology technician.
Who cannot join
- Persons not affiliated with or not covered by a social security system
- Persons subject to legal protection measures (guardianship, trusteeship)
- Persons subject to judicial protection measures
- Women who know they are pregnant
- Adults who are incapable or unable to give their consent
- Persons with contraindications to MRI
Show all 13Show fewer
- Persons who have already undergone an MRI accompanied by hypnosis
- Persons who do not speak French
- Persons who cannot read French
- Persons with cognitive disorders
- Persons who have taken sedatives before the examination
- Persons who regularly take anxiolytic medication and have increased their usual dose before the examination
- Persons who have already participated in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon
Nicolas MIGNOT, 03 80 29 30 31, nicolas.mignot@chu-dijon.fr
About this study
MRI scans are now considered essential for diagnosing or monitoring disease, and as a result, the number of MRI scans has increased significantly in recent years.
Nevertheless, these routine examinations remain a source of apprehension and anxiety for some people.
The objective of this study is to compare two methods of care, enabling anxious individuals to complete their MRI examination and obtain images of sufficient quality for the radiologist to read and interpret.
- Conditions
- Unexpected Anxiety
- Being tested
- Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire, Anxiety support procedure according to randomization: Innovision© or Hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaireOther
Assessment of patient anxiety
Anxiety support procedure according to randomization: Innovision© or HypnosisOther
Hypnosis or Innovision device
| Study group | Role | What they receive |
|---|---|---|
| Experimental Innovision© | Experimental | Not described Receives: Other: Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire; Other: Anxiety support procedure according to randomization: Innovision© or Hypnosis |
| Hypnosis control | Active comparator | Not described Receives: Other: Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire; Other: Anxiety support procedure according to randomization: Innovision© or Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of brain MRI sequences reported as interpretable
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start12 Jan 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexpected AnxietyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246746
- Sponsor's protocol ID
- MIGNOT AOIparaM 2023
- Acronym
- USIA
- Status last verified
- Jan 2026
- First submitted
- 26 Sep 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Infotainment System in MRI in Patients Suffering From Unexpected Anxiety.
- ClinicalTrials.gov ID
- NCT07246746
- Acronym / sponsor ID
- USIA / MIGNOT AOIparaM 2023
- Conditions
- Unexpected Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 24 Nov 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.
MRI scans are now considered essential for diagnosing or monitoring disease, and as a result, the number of MRI scans has increased significantly in recent years.
Nevertheless, these routine examinations remain a source of apprehension and anxiety for some people.
The objective of this study is to compare two methods of care, enabling anxious individuals to complete their MRI examination and obtain images of sufficient quality for the radiologist to read and interpret.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Innovision© | Experimental | Other: Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire, Other: Anxiety support procedure according to randomization: Innovision© or Hypnosis |
| Hypnosis control | Active comparator | Other: Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire, Other: Anxiety support procedure according to randomization: Innovision© or Hypnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals who have given their verbal consent
- Individuals over the age of 18
- Hospitalized or ambulatory individuals who are able-bodied and scheduled to undergo a brain MRI scan on the 1.5T A MRI machine at the Dijon University Hospital.
- Individuals reporting anxiety about brain MRI for the first time upon admission by the radiology technician.
Key exclusion criteria (13 listed)
- Persons not affiliated with or not covered by a social security system
- Persons subject to legal protection measures (guardianship, trusteeship)
- Persons subject to judicial protection measures
- Women who know they are pregnant
- Adults who are incapable or unable to give their consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaireAssessment of patient anxiety | Other | Experimental Innovision©, Hypnosis control |
| Anxiety support procedure according to randomization: Innovision© or HypnosisHypnosis or Innovision device | Other | Experimental Innovision©, Hypnosis control |
Primary outcome
Percentage of brain MRI sequences reported as interpretable
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire and Anxiety support procedure according to randomization: Innovision© or Hypnosis in people with Unexpected Anxiety, run by Centre Hospitalier Universitaire Dijon 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 13 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: looking for participants now, as of the sponsor's last update on 15 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas MIGNOT (03 80 29 30 31, nicolas.mignot@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of brain MRI sequences reported as interpretable (time frame: Baseline). 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 15 Jan 2026.