NCT04024917 Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis
| NCT ID | NCT04024917 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle |
| Condition | Peritoneal Carcinomatosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-09-21 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-09-21 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigator proposes to use the cardiac coherence technique to diminish anxiety before the surgery of a peritoneal carcinosis of colon or stomach or ovary and pseudomyxoma or peritoneal mesothelioma.
Eligibility Criteria
Inclusion Criteria: 1. Age over 18 years 2. Patients with peritoneal carcinosis awaiting cytoreductive surgery 3. Patients who scored strictly above 3 on the visual analogue anxiety scale and/or the psychological distress scale 4. Patients with sufficient command of the French language 5. Patient affiliated to a French social security system 6. Patient hospitalized at the Institute of cancer of Montpellier the day before his cytoreductive surgery (at T1 = D-1) 7. Signing of informed consent before any specific trial procedure Exclusion Criteria: 1. Patients who already have daily practice of cardiac coherence 2. Presence of proven psychiatric disorders (e.g., mental retardation, psychotic disorders, learning disabilities, attention deficit/hyperactivity, bipolar disorder, etc.) other than mood disorders that are reactive to the disease experience, or receiving psychotic treatment that may impair thinking, judgment or discernment 3. Physical or sensory inability to respond to questionnaires 4. Patients who have had a heart transplant or bypass surgery in the Year before surgery 5. Patient with a history of uncontrolled neurological pathology within the last 6 months before inclusion in the trial 6. Patients with a history of psychoactive substance dependence (excluding smoking) in the last 6 months before inclusion in the trial 7. Patients with brain metastases 8. Known natural bradycardia 50 beats per minute 9. Beta-blocker intake in progress 10. Ongoing cardiac arrhythmias 11. Known severe heart failure with ventricular ejection fraction strictly Below 40 % 12. Chronic uncontrolled pain and making it difficult to practice the technique 13. Patient with chronic obstructive pulmonary disease 14. Legal incapacity (patient under guardianship or curatorship)
Contact & Investigator
Estelle Guerdoux-Ninot, MD
STUDY CHAIR
Institut régional du cancer de Montpellier
Frequently Asked Questions
Who can join the NCT04024917 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peritoneal Carcinomatosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04024917 currently recruiting?
Yes, NCT04024917 is actively recruiting participants. Contact the research team at DRCI-icm105@icm.unicancer.fr for enrollment information.
Where is the NCT04024917 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT04024917 clinical trial?
NCT04024917 is sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. The principal investigator is Estelle Guerdoux-Ninot, MD at Institut régional du cancer de Montpellier. The trial plans to enroll 60 participants.