Institut régional du cancer de Montpellier
Montpellier, Hérault, 34298, France
NCT Number: NCT03981731
the investigator proposes to use the cardiac coherence technique coupled with a hypnosis session to improve post-operative recovery.
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Notify Me18 year and older
Female
Interventional
Not applicable
Montpellier, Hérault, 34298, France
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An initiation session to cardiac coherence will take place between D-10 and D-7 before the operation (during the anaesthesia consultation) in order to obtain a breathing rate of 6 cycles/min via a free application (Respirelax) with listening to an audio tape.
3 cardiac coherence sessions per day of 5 min (before meals) during the 7 days preceding the operation.
Time frame: 7 days
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.
Time frame: 7 days
The anxiety scale consists of six items, each of which could be scored from 1 to 5 with the end poles "not at all" (1) and "extremely" (5). The score of the anxiety scale is the sum of these four questions, with a scoring range from 6 to 30.
Time frame: 48 hours
The validated EVAN-G questionnaire includes 26 questions whose results are grouped together to define 6 "dimensions": Attention Focus, Information, Privacy, Pain, Discomfort and Wait Times. From these scores, an overall satisfaction score is calculated (average of all scores). For each of the scores: the higher the score, the higher the satisfaction. For each dimension, scores were reduced on a scale from 0 to 100. The higher the score, the higher the perceived quality of the experience. The total score was the sum of the scores of the six dimensions reduced to 100.
Time frame: 10 days
The quality of postoperative functional recovery will be assessed by the QoR-15 questionnaire, which assesses five dimensions of recovery (physical comfort ; emotional state ; physical independence ; physiological support ; and pain). Each item was rated on a ten-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR-15 ranges from 0 (poorest quality of recovery) to 150 (best quality of recovery).
Time frame: 7 days
It's a visual scale from 0 (no anxiety) to 100 (highest anxiety)
Time frame: 1 day
It's a visual scale from 0 (best wake-up) to 100 (worst wake-up)
Time frame: 1 day
It's a visual scale from 0 (no pain) to 100 (highest pain)
Time frame: 1 day
It's a visual scale from 0 (no fatigue) to 100 (highest fatigue)
Time frame: 1 day
It's a visual scale from 0 (ideal care) to 100 worst care)
Time frame: 1 day
Time frame: 1 day
Time frame: 1 day
Time frame: 1 day
Time frame: 1 day
Time frame: 1 day
Time frame: 1 month
Time frame: 1 day
Time frame: 1 day
It's a visual scale from 0 (no pain) to 100 (highest pain)
Time frame: 1 day
Institut du Cancer de Montpellier - Val d'Aurelle
Other
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
Acronym: COHEC
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