BridgeMD
New treatment option for Peritoneal Carcinomatosis
Official title Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis
ClinicalTrials.gov ID: NCT04024917
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, Hérault, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, Hérault, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.