Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis
Recruiting · NCT04024917 · Interventional (participants receive a specific treatment) · Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
View the official record on ClinicalTrials.gov →Interventions studied
Cardiac coherenceStandard care
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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)
Where it is running
1 location listed.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →