Using cardiac coherence to reduce anxiety in patients with peritoneal carcinosis before surgery
Implementation of a Cardiac Coherence Program to Reduce Anxiety in Patients With Peritoneal Carcinosis Treated by Surgery: Randomized Pilot Study
This study is testing if teaching patients with peritoneal carcinosis some breathing techniques can help reduce their anxiety before surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle Academic / other |
| Locations | 1 site (Montpellier, Hérault) |
| Trial ID | NCT04024917 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of cardiac coherence techniques in reducing anxiety levels in patients diagnosed with peritoneal carcinosis who are awaiting cytoreductive surgery. The intervention involves teaching patients cardiac coherence methods to help manage their psychological distress, which is common in oncology patients. The study will assess the feasibility and relevance of this non-drug intervention, given the limitations of traditional anxiolytics. Participants will be monitored for changes in anxiety and overall well-being before and after the surgery.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with a diagnosis of peritoneal carcinosis who are awaiting surgery and experiencing significant anxiety.
Not a fit: Patients with pre-existing psychiatric disorders or those already practicing cardiac coherence may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could significantly improve the psychological well-being and quality of life for patients undergoing surgery for peritoneal carcinosis.
How similar studies have performed: While studies on psychological interventions in oncology are limited, the use of non-drug therapies like cardiac coherence has shown promise in managing anxiety in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age over 18 years 2. Patients with peritoneal carcinosis awaiting cytoreductive surgery 3. Patients who scored strictly above 3 on the visual analogue anxiety scale and/or the psychological distress scale 4. Patients with sufficient command of the French language 5. Patient affiliated to a French social security system 6. Patient hospitalized at the Institute of cancer of Montpellier the day before his cytoreductive surgery (at T1 = D-1) 7. Signing of informed consent before any specific trial procedure Exclusion Criteria: 1. Patients who already have daily practice of cardiac coherence 2. 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 3. Physical or sensory inability to respond to questionnaires 4. Patients who have had a heart transplant or bypass surgery in the Year before surgery 5. Patient with a history of uncontrolled neurological pathology within the last 6 months before inclusion in the trial 6. Patients with a history of psychoactive substance dependence (excluding smoking) in the last 6 months before inclusion in the trial 7. Patients with brain metastases 8. Known natural bradycardia 50 beats per minute 9. Beta-blocker intake in progress 10. Ongoing cardiac arrhythmias 11. Known severe heart failure with ventricular ejection fraction strictly Below 40 % 12. Chronic uncontrolled pain and making it difficult to practice the technique 13. Patient with chronic obstructive pulmonary disease 14. Legal incapacity (patient under guardianship or curatorship)
Where this trial is running
Montpellier, Hérault
- Icm — Montpellier, Hérault, France (Recruiting)
Study contacts
- Study coordinator: Jean-Pierre BLEUSE, MD
- Email: DRCI-icm105@icm.unicancer.fr
- Phone: 4 67 61 31 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.