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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Hypnosis

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34298
    • Institut réginal du Cancer de Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Investigators: Study Chair: jibba AMRAOUI, Institut Régional du Cancer de Montpellier

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2014
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): February 22, 2017

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (ACTUAL): August 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ICM-URC-2014/30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO