RecruitingNot ApplicableNCT04024917

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


Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

60 participants

Start Date

Sep 21, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria14

  • 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)

Interventions

OTHERCardiac 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

OTHERStandard care

Standard care


Locations(1)

ICM

Montpellier, Hérault, France

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NCT04024917


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