NCT03253159

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2016

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 29, 2016

Last Update Submit

August 7, 2020

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Assessment of pain scale

    Pain intensity assessment

    through study completion, an average of 5 year

Secondary Outcomes (1)

  • Reduction of the pain using Visual Analogic Scale

    through study completion, an average of 5 year

Study Arms (2)

Hypnosis group

EXPERIMENTAL

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

Behavioral: Hypnosis

Control group

NO INTERVENTION

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

Interventions

HypnosisBEHAVIORAL

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

Hypnosis group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut réginal du Cancer de Montpellier

Montpellier, 34298, France

Location

Related Publications (1)

  • 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.

    PMID: 30646110DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • jibba AMRAOUI

    Institut régional du Cancer de Montpellier

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Hypnosis before intravenous anesthesia versus no preparation before intravenous anesthesia
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2016

First Posted

August 17, 2017

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

February 22, 2017

Last Updated

August 10, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)