Using cardiac coherence to reduce anxiety in patients with peritoneal carcinosis before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of cardiac coherence techniques in reducing anxiety levels in patients diagnosed with peritoneal carcinosis who are awaiting cytoreductive surgery. The intervention involves teaching patients cardiac coherence methods to help manage their psychological distress, which is common in oncology patients. The study will assess the feasibility and relevance of this non-drug intervention, given the limitations of traditional anxiolytics. Participants will be monitored for changes in anxiety and overall well-being before and after the surgery.

Why it matters

Who can join: the full rules

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)

Where it's running

• Icm
  Montpellier, Hérault, France Recruiting

Study contacts

• Study coordinator: Jean-Pierre BLEUSE, MD
• Email: DRCI-icm105@icm.unicancer.fr
• Phone: 4 67 61 31 02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.