Status:
RECRUITING
Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Peritoneal Carcinomatosis
Pseudomyxoma Peritonei
Eligibility:
All Genders
18+ years
Phase:
NA
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 mesotheli...
Detailed Description
Facing a Peritoneal Carcinomatosis (PC) diagnosis requires significant psychological adjustments that may generate major distress because of heavy care and a sometimes poor prognosis. Psychological di...
Eligibility Criteria
Inclusion
- Age over 18 years
- Patients with peritoneal carcinosis awaiting cytoreductive surgery
- Patients who scored strictly above 3 on the visual analogue anxiety scale and/or the psychological distress scale
- Patients with sufficient command of the French language
- Patient affiliated to a French social security system
- Patient hospitalized at the Institute of cancer of Montpellier the day before his cytoreductive surgery (at T1 = D-1)
- Signing of informed consent before any specific trial procedure
Exclusion
- Patients who already have daily practice of cardiac coherence
- 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
- Physical or sensory inability to respond to questionnaires
- Patients who have had a heart transplant or bypass surgery in the Year before surgery
- Patient with a history of uncontrolled neurological pathology within the last 6 months before inclusion in the trial
- Patients with a history of psychoactive substance dependence (excluding smoking) in the last 6 months before inclusion in the trial
- Patients with brain metastases
- Known natural bradycardia 50 beats per minute
- Beta-blocker intake in progress
- Ongoing cardiac arrhythmias
- Known severe heart failure with ventricular ejection fraction strictly Below 40 %
- Chronic uncontrolled pain and making it difficult to practice the technique
- Patient with chronic obstructive pulmonary disease
- Legal incapacity (patient under guardianship or curatorship)
Key Trial Info
Start Date :
September 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04024917
Start Date
September 21 2021
End Date
December 1 2025
Last Update
January 10 2025
Active Locations (1)
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1
ICM
Montpellier, Hérault, France, 34298