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

I

Institut du Cancer de Montpellier - Val d'Aurelle

Status

Completed

Conditions

Breast Cancer

Treatments

Behavioral: Hypnosis

Study type

Interventional

Funder types

Other

Identifiers

NCT03253159
ICM-URC-2014/30

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Hypnosis group
Experimental group
Description:
The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room
Treatment:
Behavioral: Hypnosis
Control group
No Intervention group
Description:
No special preparation before intravenous general anesthesia induction in the operative room

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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