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Completed

NCT Number: NCT03253159

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

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut réginal du Cancer de Montpellier

Montpellier, 34298, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hypnosis

Behavioral

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

Primary outcomes

  1. Assessment of pain scale

    Time frame: through study completion, an average of 5 year

    Pain intensity assessment

Secondary outcomes

  1. Reduction of the pain using Visual Analogic Scale

    Time frame: through study completion, an average of 5 year

    Reduction of the pain adverse postoperative outcome:

    Using Visual Analogic Scale (VAS > 3/10)

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

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

Acronym: HYPNOSEIN

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Aug 17, 2017
Registry last updated
Aug 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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