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

Breast Neoplasm Clinical Trial

— OncoHypnose  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330717
• Other study ID #: 2016/08JUL/311
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2021
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Hypnosis has already demonstrated benefits among breast cancer patients undergoing oncologic surgery. Different side effects were measured during the post operative period and at each follow up visit by physicians in order to carefully compare side effects in the 3 armes of patients..

Our hypothesis was that hypnosis sedation generates less perioperative inflammatory reaction.

A substudy of 50 patients was also dedicated to the investigation ofsalivary immunoglobulins and dosage of differents endocannabinoids

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Procedure:
• General anesthesia
Patients will undergo oncologic breast surgery on general anesthesia.
• Hypnosis sedation
Patients will undergo oncologic breast surgery on hypnosis sedation.
• General anesthesia with preoperative session of hypnosis
Patients will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Hôpital de Jolimont	Haine-Saint-Paul	Hainaut

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Substudy evaluation of salivary immunoglobulins and endocannabinoids among 50 patients (25 under general anesthesia and 25 under hypnosis sedation	Blood and salivary simples to observe if hypnosis modifies salivary parameters and endocannabinoids system	Simples collected on Day 0, 1 and 8 for endocannabinoids and salivary simples collected on Day 0 and 8