Clinical trial NCT03981731: Management of Perioperative Anxiety by the Cardiac Coherence Technique Coupled With a Hypnosis Session
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Gynecologic Cancer
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: the investigator proposes to use the cardiac coherence technique coupled with a hypnosis session to improve post-operative recovery.

Detailed description: 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) is a particular state of cardiac variability. This state is correlated with many physiological and psychological variables. It is possible to promote this state through different techniques. One of its practices, "fixed frequency guided breathing", seems relevant both in its principles and in its simplicity of implementation.

This specific respiratory mode permits to rebalance the sympathetic - parasympathetic balance of the autonomic nervous system and reveals a state of calm vigilance. This simple, well-coded respiratory psychophysiological practice is widely used in many applications, such as for the most caricatural ones, the management of difficult situations where stress is a central element such as decision-making among fighter pilots on mission, in national education to improve academic learning (especially among anxious students) and also more generally in stress and anxiety management.

This technique induces a refocusing of emotions by regulating the SNA and therefore a better regulation of the hormones involved in the emotional cascade.

This practice has several advantages:

* it is psychophysiological (psychocorporeal) 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 anxiety and independence from the presence of a third party
* it can approach a hypnotic model by focusing and absorbing what it can induce on breathing, and thus share some of its benefits
* It does not have any adverse effects. The major difficulty of this technique is the adherence and regularity of the practice. The optimal effect is dependent on regular training.

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

This study will be a study of feasibility about a program based on the cardiac coherence technique in a context of perioperative anxiety.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who have enrolled in the pre-habilitation program
timeFrame: 7 days
Secondary outcomes:
measure: The preoperative anxiety score by using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
timeFrame: 7 days
measure: Patient's satisfaction with perioperative period by using "Evaluation of the Vecu of General Anesthesia" questionnaire (EVAN-G)
timeFrame: 48 hours
measure: Measurement of the Postoperative Quality of Recovery (QoR)
timeFrame: 10 days
measure: Measurement of anxiety level by using a visual analogue scale
timeFrame: 7 days
measure: Measurement of wake-up quality by using a visual analogue scale
timeFrame: 1 day
measure: Measurement of post-operative pain by using a visual analogue scale
timeFrame: 1 day
measure: Measurement of post-operative fatigue by using a visual analogue scale
timeFrame: 1 day
measure: Measurement of comfort and satisfaction with care by using a visual analogue scale
timeFrame: 1 day
measure: Number of patients taking anesthetic drugs at induction of anaesthesia
timeFrame: 1 day
measure: Number of patients taking anesthetic drugs during the post-interventional monitoring
timeFrame: 1 day
measure: Number of patients taking morphine in recovery room
timeFrame: 1 day
measure: Number of patients taking setrons (nausea and vomiting medication)
timeFrame: 1 day
measure: Rate of patients that consider continuing the program of cardiac coherence
timeFrame: 1 day
measure: Rate of patients willing to recommend the technique
timeFrame: 1 day
measure: Number of days of hospitalization
timeFrame: 1 month
measure: Number of patients taking morphine in peroperative
timeFrame: 1 day
measure: Measurement of pain at inclusion by using a visual analogue scale
timeFrame: 1 day
measure: The recruitment rate (proportion of patients consenting to participate in the study among eligible patients at the screening) and reasons for refusal.
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut régional du cancer de Montpellier
state: Hérault
Study officials:
affiliation: Institut régional du cancer de Montpellier
name: Jibba AMRAOUI, MD
role: STUDY_CHAIR
References:
citation: Pekcan 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.
citation: Van 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.
citation: Munoz 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.
citation: Agelink 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.
citation: Lepouse 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.
citation: McCraty 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.