Clinical trial · Interventional
Assessment of Cardiac Coherence Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery
Phase III Study Evaluating a Non-drug Intervention (NDI) Program by Fixed-frequency Guided Breathing (Cardiac Coherence) Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery
NCT05197972CI-TRIAL-00088581COHEC2recruitingN/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 (Cardiac Coherence) coupled with a hypnosis session to reduce pre-operative anxiety.
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 |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cardiac coherence program coupled with hypnosis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Classic management of the preoperative period with a cardiac coherence program coupled with hypnosis.
- interventionNames
- Other: cardiac coherence program coupled with hypnosis
- type
- NO_INTERVENTION
- label
- Control group
- description
- Classic management of the preoperative period
Primary outcomes (1)
- measure
- Visual Analogue Scale (VAS) of global anxiety
- timeFrame
- The morning of the surgery (Day 0) upon arrival in the operating room
- description
- Visual Analogue Scale (VAS) of global anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor. The scale ranges from 0 (no anxiety) to 100 (maximum anxiety).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years old 2. Patient with a scheduled surgery for a cancer (suspected or declared) with a classic or ambulatory hospitalization 3. Patients requiring general anesthesia with or without associated loco-regional anesthesia or loco-regional anesthesia alone 4. Patient with a smartphone or a tablet or a computer and able to install the application 5. Inclusion of the patient minimum 7 days before the date of the surgery 6. Patient who signed the informed consent 7. Patient affiliated to a French social security system Exclusion Criteria: 1. Emergency surgery 2. Plastic surgery for reconstruction: lipomodelling 3. Prophylactic surgery: no suspected or existing cancer 4. Bradycardia (\< 50 beats/minute) with β-blockers 5. Severe heart failure with ventricular ejection fraction \< 40% 6. Uncontrolled chronic pain for more than three months on morphine 7. Patient with unstable epilepsy or respiratory pathology with rest dyspnea 8. Patient used to and having a regular and habitual practice of relaxation techniques such as yoga, hypnosis, sophrology, meditation, music therapy, virtual reality, ... 9. Medical (neurological, psychiatric, etc.) or psychological conditions not allow for participation in the protocol (completion of questionnaires and booklet, compliance with the cardiac coherence program coupled with hypnosis) 10. Deaf patient without hearing aids 11. Patient under guardianship or curatorship
References
Publications (16)
- 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
- BACKGROUNDShevde K, Panagopoulos G. A survey of 800 patients' knowledge, attitudes, and concerns regarding anesthesia. Anesth Analg. 1991 Aug;73(2):190-8. doi: 10.1213/00000539-199108000-00013. PMID 1854034
- BACKGROUNDCaumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Bandeira D, Ferreira MB. Risk factors for preoperative anxiety in adults. Acta Anaesthesiol Scand. 2001 Mar;45(3):298-307. doi: 10.1034/j.1399-6576.2001.045003298.x. PMID 11207465
- BACKGROUNDMiller SM. Coping with impending stress: psychophysiological and cognitive correlates of choice. Psychophysiology. 1979 Nov;16(6):572-81. doi: 10.1111/j.1469-8986.1979.tb01523.x. No abstract available. PMID 515298
- BACKGROUNDMiller SM, Mangan CE. Interacting effects of information and coping style in adapting to gynecologic stress: should the doctor tell all? J Pers Soc Psychol. 1983 Jul;45(1):223-36. doi: 10.1037//0022-3514.45.1.223. PMID 6886967
- BACKGROUNDKindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. doi: 10.1097/00000539-200003000-00036. PMID 10702461
- BACKGROUNDJamison RN, Taft K, O'Hara JP, Ferrante FM. Psychosocial and pharmacologic predictors of satisfaction with intravenous patient-controlled analgesia. Anesth Analg. 1993 Jul;77(1):121-5. PMID 8317718
- BACKGROUNDKulik JA, Mahler HI, Moore PJ. Social comparison and affiliation under threat: effects on recovery from major surgery. J Pers Soc Psychol. 1996 Nov;71(5):967-79. doi: 10.1037//0022-3514.71.5.967.