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NCT Number: NCT03330717

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

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de Jolimont, Haine-Saint-Paul, Hainaut, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

General Anesthesia

Procedure

Patients will undergo oncologic breast surgery on general anesthesia.

Hypnosis sedation

Procedure

Patients will undergo oncologic breast surgery on 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.

Primary outcomes

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

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

    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

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

    Time frame: Day 0, 1, 8

    Blood test performed

Secondary outcomes

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

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

    Blood and salivary simples to observe if hypnosis modifies salivary parameters and endocannabinoids system

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Acronym: OncoHypnose

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2017
Registry last updated
Jun 24, 2021

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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