Clinical trial NCT03253159: Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery
Official title: Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery: A Prospective Randomized Phase III Clinical Trial (HYPNOSEIN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hypnosis before intravenous anesthesia versus no preparation before intravenous anesthesia
Primary purpose: PREVENTION

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.

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
* Under guardianship patient or guardianship

Primary outcomes:
measure: Assessment of pain scale
timeFrame: through study completion, an average of 5 year
Secondary outcomes:
measure: Reduction of the pain using Visual Analogic Scale
timeFrame: through study completion, an average of 5 year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut réginal du Cancer de Montpellier
Study officials:
affiliation: Institut régional du Cancer de Montpellier
name: jibba AMRAOUI
role: STUDY_CHAIR
References:
citation: Amraoui J, Pouliquen C, Fraisse J, Dubourdieu J, Rey Dit Guzer S, Leclerc G, de Forges H, Jarlier M, Gutowski M, Bleuse JP, Janiszewski C, Diaz J, Cuvillon P. Effects of a Hypnosis Session Before General Anesthesia on Postoperative Outcomes in Patients Who Underwent Minor Breast Cancer Surgery: The HYPNOSEIN Randomized Clinical Trial. JAMA Netw Open. 2018 Aug 3;1(4):e181164. doi: 10.1001/jamanetworkopen.2018.1164.