Clinical trial · Interventional
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
NCT04024917CI-TRIAL-00101047COCOONrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mesothelioma Peritoneum | Peritoneal Neoplasm | PROBABILISTIC | 0.70 |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
| Pseudomyxoma Peritonei | Pseudomyxoma Peritonei | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiac coherence | Other | — | UNRESOLVED |
| Standard care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Coherence cardiac
- interventionNames
- Other: Cardiac coherence
- type
- ACTIVE_COMPARATOR
- label
- Standard care
- interventionNames
- Other: Standard care
Primary outcomes (1)
- measure
- Cardiac Coherence Program Adherence Rate
- timeFrame
- Around 10 days
- description
- Cardiac Coherence Program Adherence Rate. Patients are considered in "success" adhere to the program) if they will perform at least 20 of the 30 sessions scheduled until surgery (minimum 1 practice per day).
Secondary outcomes (18)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (42)
- BACKGROUNDDodson RM, McQuellon RP, Mogal HD, Duckworth KE, Russell GB, Votanopoulos KI, Shen P, Levine EA. Quality-of-Life Evaluation After Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy. Ann Surg Oncol. 2016 Dec;23(Suppl 5):772-783. doi: 10.1245/s10434-016-5547-y. Epub 2016 Sep 8. PMID 27638671
- BACKGROUNDLloyd-Williams M, Dennis M, Taylor F. A prospective study to determine the association between physical symptoms and depression in patients with advanced cancer. Palliat Med. 2004 Sep;18(6):558-63. doi: 10.1191/0269216304pm923oa. PMID 15453627
- BACKGROUNDPinquart M, Duberstein PR. Depression and cancer mortality: a meta-analysis. Psychol Med. 2010 Nov;40(11):1797-810. doi: 10.1017/S0033291709992285. Epub 2010 Jan 20. PMID 20085667
- BACKGROUNDElkins G, Staniunas R, Rajab MH, Marcus J, Snyder T. Use of a numeric visual analog anxiety scale among patients undergoing colorectal surgery. Clin Nurs Res. 2004 Aug;13(3):237-44. doi: 10.1177/1054773803262222. PMID 15245638
- BACKGROUNDAaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
- BACKGROUNDSugarbaker PH. Peritonectomy procedures. Ann Surg. 1995 Jan;221(1):29-42. doi: 10.1097/00000658-199501000-00004. PMID 7826158
- BACKGROUNDTan G, Dao TK, Farmer L, Sutherland RJ, Gevirtz R. Heart rate variability (HRV) and posttraumatic stress disorder (PTSD): a pilot study. Appl Psychophysiol Biofeedback. 2011 Mar;36(1):27-35. doi: 10.1007/s10484-010-9141-y.