Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery: A Prospective Randomized Phase III Clinical Trial (HYPNOSEIN)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Assessment of pain scale
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Assessment of pain scale
Time Frame: through study completion, an average of 5 year
Pain intensity assessment
Secondary Outcomes
- Reduction of the pain using Visual Analogic Scale(through study completion, an average of 5 year)