AnxietyHYPNOLINENCT05999578
Contribution of Hypnosis on Image Quality in Cardiac MRI
A study testing Hypnosis in people with Anxiety, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The present project aims to explore the effect of a hypnosis session performed on a patient with anxiety during a cardiac MRI examination on image quality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2025to May 2027
- 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
- Anxious patient (anxiety score TRAIT (baseline) and anxiety score STATE (situational) ≥ 46) and non-anxious patient (anxiety score TRAIT and anxiety score STATE < 46) requiring cardiac MRI for diagnosis or follow-up of a cardiac pathology except the patients with cardiac arrhythmias or irregular heartbeats.
- 18 years and older
- Highly effective contraception for women of childbearing potential, maintained during research procedures
- Informed consent
- Affiliated or beneficiary of health insurance
Who cannot join
- Contraindications to MRI and gadoline contrast medium
- Hearing impaired patients
- Patients who do not speak French
- Women who are pregnant or lactating
- Inability to agree to participate to the study
- Patient under legal protection
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 Bordeaux
Bordeaux
Amandine ANDRE-BILLEAU, +33557820000 ext. 74634, amandine.andre@chu-bordeaux.fr
About this study
Official title: Evaluating the Contribution of Hypnosis on Image Quality During Cardiac Magnetic Resonance Imaging (MRI) in Anxious Patients
The present project aims to explore the effect of a hypnosis session performed on a patient with anxiety during a cardiac MRI examination on image quality.
Read the detailed description
Cardiac Magnetic Resonance Imaging (MRI) is an activity of the Bordeaux University Hospital that continues to grow (+7.3% in 2021 compared to 2019) under the combined effect of the increase in activity of cardiology care channels and the extension of clinical indications for cardiac MRI. Indeed, cardiac MRI has become an essential examination in the diagnosis of many heart diseases and is little practiced elsewhere in New Aquitaine. The current delay for a cardiac MRI is 3 and a half months.
In this context, it is necessary to be efficient because any procedure failure, examination interruption or insufficient image quality can delay the diagnosis and therapeutic management of the patient for several months. Numerous studies have shown that anxiety induces interruptions in the acquisition of MRI images and repetition of sequences, thus prolonging the examination time.
However, no study takes into account the specificity of cardiac MRI, whose image quality is intimately linked to the patient's cooperation and to the synchronization of the sequences with the heart rhythm.
Hypnosis seems to be adapted to reduce the patient's anxiety, by allowing him to ignore the surrounding reality while remaining in relation with the attendant.
The hypothesis is that by reducing patient anxiety through hypnosis, image quality in cardiac MRI would be improved.
- Conditions
- Anxiety
- Being tested
- Hypnosis
- Keywords
- hypnosis, cardiac MRI, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisOther
Hypnosis support before, during and at the end of cardiac MRI exam
| Study group | Role | What they receive |
|---|---|---|
| Anxious patients with hypnosis | Experimental | Hypnosis support before, during and at the end of cardiac MRI exam Receives: Other: Hypnosis |
| Anxious patients without hypnosis | No intervention | Cardiac MRI exam accordingly to usual care |
| Non anxious patients | No intervention | Cardiac MRI exam accordingly to usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of cardiac MRI images
Likert score measurements
Measured: Baseline
Secondary outcomes (7)
number of artifacts
The number of artifacts will be estimated with European CMR Registry objective score.
Measured: Baseline
Diagnostic validation score
The diagnostic validation score for the entire examination (and not sequence by sequence) makes it possible to define whether, despite the presence of artifacts, the examination makes it possible to answer the question initially asked in the examination request.
Measured: Baseline
Causality score measurement
Causality score measurement for examinations with a Likert score < 4
Measured: Baseline
Overall duration
The overall duration of the examination and the different phases (reception and preparation time, image acquisition time).
Measured: Baseline
Number of repeated or interrupted sequences
The number of repeated or interrupted sequences (by the Radiographer or the patient).
Measured: Baseline
Anxiety level
The Spielberg State Anxiety Index STAI-Y anxiety score will be used to estimate patient anxiety before and after the MRI.
Measured: Baseline
Post-MRI satisfaction score
The post-MRI satisfaction score will be estimated from the patient by a visual analog scale rated from 0 (not at all satisfied) to 10 (very satisfied).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start15 Apr 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999578
- Sponsor's protocol ID
- CHUBX 2022/79
- Acronym
- HYPNOLINE
- Status last verified
- Sep 2025
- First submitted
- 11 Aug 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Contribution of Hypnosis on Image Quality During Cardiac Magnetic Resonance Imaging (MRI) in Anxious Patients
- ClinicalTrials.gov ID
- NCT05999578
- Acronym / sponsor ID
- HYPNOLINE / CHUBX 2022/79
- Conditions
- Anxiety
- Keywords
- hypnosis, cardiac MRI, anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 21 Aug 2023 (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.
The present project aims to explore the effect of a hypnosis session performed on a patient with anxiety during a cardiac MRI examination on image quality.
Detailed description
Cardiac Magnetic Resonance Imaging (MRI) is an activity of the Bordeaux University Hospital that continues to grow (+7.3% in 2021 compared to 2019) under the combined effect of the increase in activity of cardiology care channels and the extension of clinical indications for cardiac MRI. Indeed, cardiac MRI has become an essential examination in the diagnosis of many heart diseases and is little practiced elsewhere in New Aquitaine. The current delay for a cardiac MRI is 3 and a half months.
In this context, it is necessary to be efficient because any procedure failure, examination interruption or insufficient image quality can delay the diagnosis and therapeutic management of the patient for several months. Numerous studies have shown that anxiety induces interruptions in the acquisition of MRI images and repetition of sequences, thus prolonging the examination time.
However, no study takes into account the specificity of cardiac MRI, whose image quality is intimately linked to the patient's cooperation and to the synchronization of the sequences with the heart rhythm.
Hypnosis seems to be adapted to reduce the patient's anxiety, by allowing him to ignore the surrounding reality while remaining in relation with the attendant.
The hypothesis is that by reducing patient anxiety through hypnosis, image quality in cardiac MRI would be improved.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anxious patients with hypnosis | Experimental | Other: HypnosisHypnosis support before, during and at the end of cardiac MRI exam |
| Anxious patients without hypnosis | No intervention | –Cardiac MRI exam accordingly to usual care |
| Non anxious patients | No intervention | –Cardiac MRI exam accordingly to usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Anxious patient (anxiety score TRAIT (baseline) and anxiety score STATE (situational) ≥ 46) and non-anxious patient (anxiety score TRAIT and anxiety score STATE < 46) requiring cardiac MRI for diagnosis or follow-up of a cardiac pathology except the patients with cardiac arrhythmias or irregular heartbeats.
- 18 years and older
- Highly effective contraception for women of childbearing potential, maintained during research procedures
- Informed consent
- Affiliated or beneficiary of health insurance
Key exclusion criteria (6 listed)
- Contraindications to MRI and gadoline contrast medium
- Hearing impaired patients
- Patients who do not speak French
- Women who are pregnant or lactating
- Inability to agree to participate to the study
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 |
|---|---|---|
| HypnosisHypnosis support before, during and at the end of cardiac MRI exam | Other | Anxious patients with hypnosis |
Primary outcome
quality of cardiac MRI images
Time frame: Baseline
Likert score measurements
7 secondary outcomes
number of artifacts
Time frame: Baseline
Diagnostic validation score
Time frame: Baseline
Causality score measurement
Time frame: Baseline
Overall duration
Time frame: Baseline
Number of repeated or interrupted sequences
Time frame: Baseline
Anxiety level
Time frame: Baseline
Post-MRI satisfaction score
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 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Anxiety, run by University Hospital, Bordeaux 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 5 inclusion and 6 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 Sep 2025. 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 Amandine ANDRE-BILLEAU (+33557820000 ext. 74634, amandine.andre@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of cardiac MRI images (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 Sep 2025.