Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery

Study Overview
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Brief Summary
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Evaluate the impact of the support in reducing postoperative adverse events in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.

Detailed Description
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Drug premedication with anxiolytics (benzodiazepine or equivalent) are usually prescribed to alleviate patient anxiety. However, alternative techniques, additional non-pharmacological, have proven effective in alleviating pain and anxiety perioperative. These techniques are retained relaxation therapy, reinsurance, breathing techniques and medical hypnosis as a technique of choice. Regarding medical hypnosis techniques, many studies have shown that performing a hypnotic technique performed perioperative could reduce the doses of anesthetics, postoperative pain, length of stay in the post room Interventional (SSPI) and a number of postoperative adverse effects. Among the various techniques of hypnosis that can be offered to patients in the perioperative, conversational hypnosis is to accompany the patient on admission to the block to realization of general anesthesia. This technique aims to suggest a pleasant environment and not anxiety. This study evaluate the impact of this support in reducing postoperative major adverse effects in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.

Official Title
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Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery: A Prospective Randomized Phase III Clinical Trial (HYPNOSEIN)

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Hypnosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female > 18 years Patient with ASA* score 1, 2, 3 Minor Unilateral breast surgery indication (tumorectomy, lumpectomy, limited axillary node dissection, minor breast reconstruction…) Day case surgery (ambulatory surgery - living Day0-Day1) General anesthesia required Written informed consent French medical benefit Exclusion Criteria: Age < 18 years Patient with ASA score > 4; Body mass index < 15 or 45kg/T; Major Surgery indication : mastectomy, bilateral surgery, full axillary dissection, major breast reconstruction Patient refusing hypnosis Psychic or mental Disorders Chronic pain Opiate therapeutic > 3 months Not ability to speak and read French language Deaf and dumb patient Under guardianship patient or guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Hypnosis before intravenous anesthesia versus no preparation before intravenous anesthesia
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis group<br>The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room | Behavioral: Hypnosis<br>* The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room.<br>|
| No Intervention: Control group<br>No special preparation before intravenous general anesthesia induction in the operative room | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pain scale | Pain intensity assessment | through study completion, an average of 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the pain using Visual Analogic Scale | Reduction of the pain adverse postoperative outcome: Using Visual Analogic Scale (VAS > 3/10) | through study completion, an average of 5 year |