Interventional Study on the Impact of the Hypnosis Used as Sedation or Relaxation in the Breast Oncologic Surgery

NCT03330717 | Completed

• 1 other identifier: 2016/08JUL/311
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 2

Brief Summary

The aims of the study are to compare the recovering period between a group of patients with conventional sedation, a group using hypnosis as sedation during the surgery and a third group using hypnosis as a relaxation method and preparation but enjoying a classic sedation for their surgery. Comparaison of pain ( different types of pain), consumption of pain killers ,anxiety and fatigue on day0,1, 8 after surgery and every. 3 months during the first 2 years of follow up. Comparisons are also performed in substudies defined by treatments modalités. Inflammatory parameters s ( CRP\_ C reactive protein, NLR- ( neutrophils to lymphocyte ratio) are measured on Day 0, 1, 8 and also salivary Immunoglobulins and different endocannabinoids.

Conditions

Breast Neoplasm

Outcome Measures

Primary Outcomes (2)

• Number of the days spent at the hospital post-surgery between the three groups

  The aim of the study is to compare the recovering period hospitalisation and the different side effects (pain, anxiety, fatigue and consumption of pain killers ) during the post opérative period ( day 0, 1, 8- and at each follow up visit) between a group of patients with conventional sedation, a group using hypnosis as sedation during the surgery and a third group using hypnosis as a relaxation method and preparation but enjoying a classic sedation for their surgery

  Day 0, 1, 8 and every 3 months for 2 years after surgery

• Comparaison of inflammatory parameters measured on day 0,1,8: CRP ( c reactive protein) and NLR ( neutrophils to lymphocyte ratio)

  Blood test performed

  Day 0, 1, 8

Secondary Outcomes (1)

• Substudy evaluation of salivary immunoglobulins and endocannabinoids among 50 patients (25 under general anesthesia and 25 under hypnosis sedation

  Simples collected on Day 0, 1 and 8 for endocannabinoids and salivary simples collected on Day 0 and 8

Study Arms (3)

General anesthesia

PLACEBO COMPARATOR

Patients will undergo oncologic breast surgery on general anesthesia.

Procedure: General anesthesia

Hypnosis sedation

EXPERIMENTAL

Patients will undergo oncologic breast surgery on hypnosis sedation.

Procedure: Hypnosis sedation

General anesthesia with preoperative session of hypnosis

EXPERIMENTAL

Patients interested in hypnosis but too anxious to have surgery while on hypnosis sedation will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation using technology of virtual reality

Procedure: General anesthesia with preoperative session of hypnosis

Interventions

General anesthesia PROCEDURE

Patients will undergo oncologic breast surgery on general anesthesia.

General anesthesia

Hypnosis sedation PROCEDURE

Patients will undergo oncologic breast surgery on hypnosis sedation.

Hypnosis sedation

General anesthesia with preoperative session of hypnosis PROCEDURE

Patients will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation.

General anesthesia with preoperative session of hypnosis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Only women with breast cancer will be included
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18 years old
• Signed informed consent form
• Patient has to be in possession of her administrative laws and affiliated to the social security insurance.
• The patient must have a diagnosis of resectable breast cancer (in situ or invasive breast cancer). . Surgical procedure must include evaluation of the axillary area (sentinel lymph node biopsy and or axillary dissection)

You may not qualify if:

• Patient under 18 years old
• No signed informed consent form
• Patients who haven't her social security insurance and prisoners are not eligible.
• No evaluation of the axillary area.
• Breast cancer in men

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (2)

Hôpital de Jolimont

Haine-Saint-Paul, Hainaut, 7100, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Martine Berlière, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: November 6, 2017
• Study Start: November 15, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 24, 2021

Record last verified: 2021-06

Locations

BE (2)