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CompletedNCT03253159HYPNOSEINUpdated Aug 10, 2020

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

An interventional study of Hypnosis in Breast Cancer, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-10.

Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • 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

  • No intervention
    Control group

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

Interventions

  • BehavioralHypnosis

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

05

What researchers measure

Primary outcomes

  1. Assessment of pain scale

    Pain intensity assessment

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

Secondary outcomes

  1. Reduction of the pain using Visual Analogic Scale

    Reduction of the pain adverse postoperative outcome: Using Visual Analogic Scale (VAS \> 3/10)

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

06

Study locations

1 site
  • Institut réginal du Cancer de Montpellier
    Montpellier, 34298, France
07

References and documents

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. PubMed 30646110 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03253159
Lead sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Responsible party
Sponsor
First posted
Aug 17, 2017
Start date
Sep 2014
Primary completion
Sep 2016
Completion
Feb 22, 2017
Last update
Aug 10, 2020

Study contacts

jibba AMRAOUI
study chair · Institut régional du Cancer de Montpellier

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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