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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-02-22

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.

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Hypnosis before intravenous anesthesia versus no preparation before intravenous anesthesia

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hypnosis group

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

Group Type EXPERIMENTAL

Hypnosis

Intervention Type BEHAVIORAL

The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room.

Control group

No special preparation before intravenous general anesthesia induction in the operative room

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hypnosis

The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No