US Clinical Trial NCT03981731

Management of Perioperative Stress by the Cardiac Coherence Technique Coupled With a Hypnosis Session, as Part of the Improved Pre-habilitation After Surgery.  Jun 7, 2019

The perioperative period is recognized as an anxiety-provoking period for patients. If for some patients, this anxiety is more or less manageable, for others, it is the major concern with regard to their intervention, fearing not to wake up, to remain in a coma. Consideration of this aspect is very important for patients who require surgery. It is also a concern for caregivers involved in the care of these patients, including anesthesiologists, surgeons and operating room staff.

For many years, pharmacological premedication, including benzodiazepines, has been the gold standard in the treatment of preoperative anxiety.

This systematic prescription is controversial in populations most exposed to side effects such as the elderly, patients with heart or respiratory diseases.

Surgery also seems to influence the impact of premedication. For example, abdominal surgery and breast surgery are associated with a higher risk of agitation upon awakening.

Mental preparation, based on simple explanations by the anaesthetist, is not enough to reduce patients' anxiety.

A recent study evaluated the perioperative experience of patients receiving or not receiving premedication. It shows that benzodiazepines are associated with cognitive impairment and delayed extubation in the elderly. In addition, it seems to have little effect on patient anxiety when compared to a placebo.

In this context of anxiety, an emotional regulation tool appears particularly relevant. Cardiac coherence (CC)", also known as "fixed rate guided breathing", is a measurable physiological function that has been known for many years and has been the subject of numerous studies published in the scientific literature.

Cardiac coherence involves breathing, itself involved in the automatic regulation of the autonomous nephew system (ANS), composed of the orthosympathetic system (role in increasing blood pressure, heart rate, secretion of adrenaline, cortisol...) and the parasympathetic system (slowing heart rate, lowering blood pressure, better transmission of neurotransmitters...).

This simple and well-coded breathing technique is widely used in military medicine to facilitate decision-making in difficult situations and in national education to improve academic learning.

This technique induces a refocusing of emotions by regulating the autonomic nervous system and therefore a better regulation of the hormones involved in the emotional cascade. It has several advantages:

- it is physiological and widely described in the scientific literature in several indications

- it is completely free of charge and immediately accessible to the patient, regardless of time and place

- it can be used at other anxiety-inducing times (e.g., imaging or biopsy tests)

- it allows total patient autonomy, offering self-management of stress and independence from the presence of a third party

- it can approach a hypnotic model by focusing and absorbing it on the breath, and thus share some of its benefits and without adverse effects.

The major difficulty of this technique is the adherence and regularity of the practice.

To improve this adherence, the investigator proposes to put online a 6-minute audio tape, read in a hypnotic tone, which will aim to explain respiratory physiology, the benefits of oxygenation on the cells and metabolism; this will have the effect of understanding the interest and usefulness of this exercise and will contribute to induce a feeling of relaxation and well-being.

The investigator therefore proposes to study the feasibility of a program based on the cardiac coherence technique in a context of perioperative stress.

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Keywords
Breast Cancer COHEC Gynecologic Cancer

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Source:  NIH Last updated:  Jun 12, 2019

From ClinicalTrials.gov, a database of the U.S. National Institutes of Health, through its National Library of Medicine. This record may not reflect the most current and accurate biomedical/scientific data available from the NLM/NIH.