Clinical trial · Interventional
Management of Perioperative Anxiety by the Cardiac Coherence Technique Coupled With a Hypnosis Session
Management of Perioperative Anxiety by the Fixed Rate Guided Breathing Technique (Cardiac Coherence) Coupled With a Hypnosis Session, as Part of the Improved Pre-habilitation After Surgery
NCT03981731CI-TRIAL-00102489COHECcompletedN/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 coupled with a hypnosis session to improve post-operative recovery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiac coherence | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cardiac coherence
- interventionNames
- Other: Cardiac coherence
Primary outcomes (1)
- measure
- Proportion of patients who have enrolled in the pre-habilitation program
- timeFrame
- 7 days
- description
- A patient will be considered to have optimally adhered to the program if she performs at least 2/3 of the proposed cardiac coherence sessions (that represents 67% of the total number of sessions), that is, at least 14 sessions over the 7 days preceding the surgery.
Secondary outcomes (18)
- measure
- The preoperative anxiety score by using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
- timeFrame
- 7 days
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years old 2. Surgery for breast or gynaecological cancer requiring scheduled hospitalization for up to 3 days 3. Signing of informed consent before any specific procedure in the study 4. Patient affiliated to a social security system Exclusion Criteria: 1. Patients undergoing outpatient surgery for their cancer will not be included 2. Natural bradycardia (50 beats per minute) 3. Patient taking β-blockers, digoxin, flecaine, isoptin, cordarone, diltiazem 4. Cardiac arrhythmias 5. Severe heart failure with ventricular ejection fraction \< 40% 6. Uncontrolled chronic pain 7. Patients whose medical or psychological conditions do not allow them to complete the study or sign the consent 8. Patient does not understand the French language 9. Deaf and/or dumb patient 10. Adult patient under guardianship or curatorship
References
Publications (7)
- BACKGROUNDPekcan M, Celebioglu B, Demir B, Saricaoglu F, Hascelik G, Yukselen MA, Basgul E, Aypar U. The effect of premedication on preoperative anxiety. Middle East J Anaesthesiol. 2005 Jun;18(2):421-33. PMID 16438017
- BACKGROUNDVan den Bosch JE, Moons KG, Bonsel GJ, Kalkman CJ. Does measurement of preoperative anxiety have added value for predicting postoperative nausea and vomiting? Anesth Analg. 2005 May;100(5):1525-1532. doi: 10.1213/01.ANE.0000149325.20542.D4. PMID 15845719
- BACKGROUNDMunoz HR, Dagnino JA, Rufs JA, Bugedo GJ. Benzodiazepine premedication causes hypoxemia during spinal anesthesia in geriatric patients. Reg Anesth. 1992 May-Jun;17(3):139-42. PMID 1606095
- BACKGROUNDAgelink MW, Majewski TB, Andrich J, Mueck-Weymann M. Short-term effects of intravenous benzodiazepines on autonomic neurocardiac regulation in humans: a comparison between midazolam, diazepam, and lorazepam. Crit Care Med. 2002 May;30(5):997-1006. doi: 10.1097/00003246-200205000-00008. PMID 12006794
- BACKGROUNDLepouse C, Lautner CA, Liu L, Gomis P, Leon A. Emergence delirium in adults in the post-anaesthesia care unit. Br J Anaesth. 2006 Jun;96(6):747-53. doi: 10.1093/bja/ael094. Epub 2006 May 2. PMID 16670111
- BACKGROUNDMcCraty R, Atkinson M, Tiller WA, Rein G, Watkins AD. The effects of emotions on short-term power spectrum analysis of heart rate variability. Am J Cardiol. 1995 Nov 15;76(14):1089-93. doi: 10.1016/s0002-9149(99)80309-9. PMID 7484873
- RESULTAmraoui J, Leclerc G, Jarlier M, Diaz J, Guler R, Demoly C, Verin C, Rey Dit Guzer S, Chalbos P, Moussion A, Taoum C, Neron M, Philibert L. Cardiac coherence and medical hypnosis: a feasibility study of a new combined approach for managing preoperative anxiety in patients with breast or gynaecological cancer. BJA Open. 2024 Sep 24;12:100309. doi: 10.1016/j.bjao.2024.100309. eCollection 2024 Dec.