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NCT04024917Recruiting

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

Implementation of a Cardiac Coherence Program to Reduce Anxiety in Patients With Peritoneal Carcinosis Treated by Surgery: Randomized Pilot Study

Source: ClinicalTrials.gov · Last updated 16 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
15 Jul 2019
Start date
21 Sept 2021
Primary completion date
31 Dec 2026
Lead sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Diseases
Mesothelioma
NCT number
NCT04024917

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 21 Sept 2021 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • Patients who already have daily practice of cardiac coherence
  • Patients who have had a heart transplant or bypass surgery in the Year before surgery
  • Ongoing cardiac arrhythmias
  • Patient with chronic obstructive pulmonary disease

Lab values

  • Known severe heart failure with ventricular ejection fraction strictly Below 40 %

Other

  • Physical or sensory inability to respond to questionnaires
  • Patients with brain metastases
  • Known natural bradycardia 50 beats per minute
  • Beta-blocker intake in progress
  • Chronic uncontrolled pain and making it difficult to practice the technique
  • Legal incapacity (patient under guardianship or curatorship)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ICM
Coordinator of this site? Confirm its status
MontpellierFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.