NCT05197972

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 296 (estimated)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigator proposes to use the cardiac coherence technique (Cardiac Coherence) coupled with a hypnosis session to reduce pre-operative anxiety.

Detailed description

The perioperative period is recognized as anxiety-provoking for most patients. In oncology, 60 to 80% of patients suffer from stress throughout their treatment. If for some patients, this anxiety is more or less manageable, for others, it is the major concern with regard to their intervention. For many years, pharmacological premedication, especially with benzodiazepines, has been the gold standard for the treatment of preoperative anxiety, but this systematic prescription is increasingly controversial, especially in populations most exposed to side effects, such as elderly subjects and patients with cardiac or respiratory pathologies. The aim of this study is to propose an alternative to pharmacological premedication by a non-drug approach. The two techniques (the Fixed Rate Guided Breathing Technique = cardiac coherence and hypnosis) can potentiate each other and become synergistic. Thus, for patients undergoing oncological surgery, regular practice of cardiac coherence coupled with hypnosis prior to their surgery should enable them to better manage perioperative anxiety and thus significantly reduce their level of anxiety on the day of their surgery. The association of the 2 techniques combines several advantages: * It is totally "physiological", free and immediately available for the patient and without any undesirable effect; * It gives autonomy to the patient to manage his stress, making him independent of chemical molecules, the presence of a third party or expensive equipment. * It will allow oncology patients to use it throughout their care (invasive examinations, MRI imaging, heavy and complex care such as certain dressings, etc.) This work will allow: * To give oncology patients the possibility to be actors of their care by a self-management of their anxiety in substitution or complement of a medicated approach; * To map anxiety in oncology surgery using a simple scale such as the EVA, which has not yet been done; * To identify the most anxious patients in order to provide them with the appropriate management (pharmacological and/or NMI) before their surgery; * To evaluate the correlation between the level of preoperative anxiety and the occurrence of postoperative adverse events; * To evaluate the correlation between the level of anxiety and the quality of recovery (QoR) and the postoperative experience (EVAN-G). Patients in the experimental group will be interviewed to explain how to perform the cardiac coherence and hypnosis sessions at home before the surgery.

Conditions

• Surgery
• Oncology

Interventions

Type	Name	Description
OTHER	cardiac coherence program coupled with hypnosis	At home the patient will perform the cardiac coherence sessions between 7 days and a maximum of 15 days before the surgery through the application "Respirelax": 3 sessions per day, lasting 5 minutes with a breathing frequency of 6 cycles/min for a period of 7 days minimum and maximum 15 days. An audio tape read in a hypnotic tone can be listened to by the patient during the cardiac coherence program or at another time of the day (see the text of the audio tape).

Timeline

• Start date: 2022-06-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2022-01-20
• Last updated: 2025-04-16

Locations

4 sites across 1 country: France