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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Hypnosis

• Registration Number: NCT03253159
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-08-29
• Primary Completion: 2016-09
• Study Completion: 2017-02-22
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-17
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-07
• Last Update Posted: 2020-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypnosis group	Hypnosis	The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room

Primary Outcome Measures

Name	Time	Method
Assessment of pain scale	through study completion, an average of 5 year	Pain intensity assessment

Secondary Outcome Measures

Name	Time	Method
Reduction of the pain using Visual Analogic Scale	through study completion, an average of 5 year	Reduction of the pain adverse postoperative outcome: Using Visual Analogic Scale (VAS \> 3/10)

Trial Locations

Locations (1)

Institut réginal du Cancer de Montpellier; 🇫🇷 Montpellier, France