AnxietyRESP-IRMNCT05893121
Evaluation of a Cardiac Coherence Session to Reducing Patients' Anxiety During a MRI Examination
An observational study of Anxiety, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The present project aims at conducting a proof of concept study to explore the pertinence of a single session of cardiac coherence, carried out in patients prior to an MRI examination and presenting anxiety in relation to this examination, to reduce their level of anxiety and thus improve the course of the examination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Cardiac coherence session and Information note about MRI
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2023to 30 Sep 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: subject with moderate or high anxiety ( score ≥ 4 ) in relation to MRI exam
Who may be able to join
- Person affiliated to or benefiting from a social security scheme;
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research);
- Patient to undergo an MRI examination of the upper half of the body
- Patient over 18 years old
- Patient with a high level of anxiety (score ≥ 4) in relation to MRI
- Non-inclusion Criteria:
Show all 10Show fewer
- Patient under legal protection or under another protection regime (guardianship, curatorship).
- Sedated or unconscious patient
- Patient performing an emergency MRI examination
- Patient with a level of French language that does not allow sufficient understanding for the completion of questionnaires
Who cannot join
- STAI Y-A score < 46 (insignificant or low anxiety)
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
Pierre Paul Riquet Hospital
Toulouse, 31000
Jean-Pierre DESIRAT, 05 34 55 74 75 ext. +33, desirat.jp@chu-toulouse.fr
Frédéric BROUILLET
About this study
Official title: Evaluating the Contribution of a Cardiac Coherence Session to Reducing Patients' Anxiety During a Medical Magnetic Resonance Imaging Examination
The present project aims at conducting a proof of concept study to explore the pertinence of a single session of cardiac coherence, carried out in patients prior to an MRI examination and presenting anxiety in relation to this examination, to reduce their level of anxiety and thus improve the course of the examination.
Read the detailed description
Although Magnetic Resonance Imaging (MRI) is considered to be biologically safe and painless, the examination is often perceived by patients as difficult to bear, causing a great deal of anxiety due to the various constraints: the upper half of the body, including the head, positioned in a tube with a circumference of approximately 70 cm, relatively long duration, immobilization and even restraint. However, all these conditions are necessary to obtain good quality images, which are essential for the interpretation of the examination for diagnostic purposes by the clinicians.
The anxiety of patients linked to the performance of an MRI examination and its negative effects are documented in the literature. According to some authors, 71% of the professionals surveyed stated that anxiety was a common problem in their MRI centre and 19% stated that it regularly disrupted the examination. It is estimated that 10% of the motion artefacts present on MRI examinations are caused by anxiety-related motor agitation, making image quality difficult to exploit. Thus, every day, many MRI examinations are cancelled, interrupted, or of poor quality due to movement and difficult to interpret. All these examinations must therefore be rescheduled, with delays that can be several months long.
Among these non-drug methods, cardiac coherence seems promising. This method is recent, non-invasive, of short duration, very easy to implement and requires little training for users.
The present study hypothesize that a single session of cardiac coherence, carried out in patients prior to an MRI examination and presenting anxiety in relation to this examination, could make it possible to reduce their level of anxiety and thus improve the course of the examination.
- Conditions
- Anxiety
- Being tested
- Cardiac coherence session, Information note about MRI
- Keywords
- cardiac coherence, improving patient management
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac coherence sessionOther
A cardiac coherence session consists of an exercise of six breaths per minute during five minutes.
Information note about MRIOther
explanatory note about MRI examination
| Study group | Role | What they receive |
|---|---|---|
| Control | subjects who received information about MRI examination Receives: Other: Information note about MRI | |
| Experimental | Subjects who received information about MRI examination and one cardiac coherence session Receives: Other: Cardiac coherence session; Other: Information note about MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of a cardiac coherence session on the anxiety level
The anxiety level will be measured by the Y-A form of the Spielberger State-Trait Anxiety Inventory (French version adapted from the "State-Trait Anxiety Inventory" - STAI) in all patients before the MRI examination is performed
Measured: 10 minutes
Secondary outcomes (5)
MRI examination quality
The quality of the MRI examination will be measured at the end of the examination, blinded to the allocation group
Measured: 30 minutes
Physiological parameters
Physiological parameters reflecting the patients' level of anxiety will be measured in all patients before the MRI examination is carried out; before and after reading an information document and performing cardiac coherence for patients in the experimental group, after reading the information document for the control group.
Measured: 30 minutes
patient satisfaction
A satisfaction questionnaire will be used at the end of the MRI examination (2 questions).
Measured: 30 minutes
Economic evaluation
The time spent preparing the patient and the time related to the cardiac coherence consultation
Measured: 30 minutes
Other economic evaluation
The costs related to the imaging act from the point of view of the health insurance
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start8 Dec 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (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, ToulouseThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre DESIRAT, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893121
- Sponsor's protocol ID
- RC31/22/0483
- Acronym
- RESP-IRM
- Status last verified
- Jul 2026
- First submitted
- 20 Mar 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Contribution of a Cardiac Coherence Session to Reducing Patients' Anxiety During a Medical Magnetic Resonance Imaging Examination
- ClinicalTrials.gov ID
- NCT05893121
- Acronym / sponsor ID
- RESP-IRM / RC31/22/0483
- Conditions
- Anxiety
- Keywords
- cardiac coherence, improving patient management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 7 Jun 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 at conducting a proof of concept study to explore the pertinence of a single session of cardiac coherence, carried out in patients prior to an MRI examination and presenting anxiety in relation to this examination, to reduce their level of anxiety and thus improve the course of the examination.
Detailed description
Although Magnetic Resonance Imaging (MRI) is considered to be biologically safe and painless, the examination is often perceived by patients as difficult to bear, causing a great deal of anxiety due to the various constraints: the upper half of the body, including the head, positioned in a tube with a circumference of approximately 70 cm, relatively long duration, immobilization and even restraint. However, all these conditions are necessary to obtain good quality images, which are essential for the interpretation of the examination for diagnostic purposes by the clinicians.
The anxiety of patients linked to the performance of an MRI examination and its negative effects are documented in the literature. According to some authors, 71% of the professionals surveyed stated that anxiety was a common problem in their MRI centre and 19% stated that it regularly disrupted the examination. It is estimated that 10% of the motion artefacts present on MRI examinations are caused by anxiety-related motor agitation, making image quality difficult to exploit. Thus, every day, many MRI examinations are cancelled, interrupted, or of poor quality due to movement and difficult to interpret. All these examinations must therefore be rescheduled, with delays that can be several months long.
Among these non-drug methods, cardiac coherence seems promising. This method is recent, non-invasive, of short duration, very easy to implement and requires little training for users.
The present study hypothesize that a single session of cardiac coherence, carried out in patients prior to an MRI examination and presenting anxiety in relation to this examination, could make it possible to reduce their level of anxiety and thus improve the course of the examination.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Information note about MRIsubjects who received information about MRI examination |
| Experimental | – | Other: Cardiac coherence session, Other: Information note about MRISubjects who received information about MRI examination and one cardiac coherence session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- subject with moderate or high anxiety ( score ≥ 4 ) in relation to MRI exam
Key inclusion criteria (10 listed)
- Person affiliated to or benefiting from a social security scheme;
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research);
- Patient to undergo an MRI examination of the upper half of the body
- Patient over 18 years old
- Patient with a high level of anxiety (score ≥ 4) in relation to MRI
Key exclusion criteria (1 listed)
- STAI Y-A score < 46 (insignificant or low anxiety)
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 |
|---|---|---|
| Cardiac coherence sessionA cardiac coherence session consists of an exercise of six breaths per minute during five minutes. | Other | Experimental |
| Information note about MRIexplanatory note about MRI examination | Other | Control, Experimental |
Primary outcome
Effect of a cardiac coherence session on the anxiety level
Time frame: 10 minutes
The anxiety level will be measured by the Y-A form of the Spielberger State-Trait Anxiety Inventory (French version adapted from the "State-Trait Anxiety Inventory" - STAI) in all patients before the MRI examination is performed
5 secondary outcomes
MRI examination quality
Time frame: 30 minutes
Physiological parameters
Time frame: 30 minutes
patient satisfaction
Time frame: 30 minutes
Economic evaluation
Time frame: 30 minutes
Other economic evaluation
Time frame: 30 minutes
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 16 Jul 2026.
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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.
Jean-Pierre DESIRAT principal investigator
University Hospital, Toulouse
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, run by University Hospital, Toulouse 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 10 inclusion and 1 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 16 Jul 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 Jean-Pierre DESIRAT (0534557475 ext. +33, desirat.jp@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of a cardiac coherence session on the anxiety level (time frame: 10 minutes). 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 16 Jul 2026.