Ireland
--:--IST
Recruiting Not applicable

Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis

NCT04024917 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-09-21
Last updated
2026-01-16

Condition(s) studied

Peritoneal CarcinomatosisPseudomyxoma PeritoneiMesothelioma Peritoneum

Investigational drug(s) / intervention(s)

Cardiac coherenceStandard care

Cardiac coherence: An initiation session to cardiac coherence will take place D-11 before the operation (during the surgical consultation) in order to obtain a breathing rate of 6 cycles/min via a free application (Respirelax) with listening to an audio tape. 3 cardiac coherence sessions per day of 5 min (before meals) during the 11 days preceding the operation. \- The program cardiac coherence will be performed during 90 days after the surgery

Standard care: Standard care

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Cardiac Coherence Program Adherence Rate — Around 10 days
    Cardiac Coherence Program Adherence Rate. Patients are considered in "success" adhere to the program) if they will perform at least 20 of the 30 sessions scheduled until surgery (minimum 1 practice per day).

Trial sites (1)

FacilityCityRegionStatus
ICM Montpellier Hérault Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04024917 on ClinicalTrials.gov ↗ ← All trials in France