Evaluation of Medical and Economic Incidence of Hypnosis (HYPNONISAT°)

Evaluation of Medical and Economic Incidence of Hypnosis in Conization

Hypnosis in conization is more and more use to substitute General Anesthesia (GA) in Anesthesia's field.

This study wants to prove that the Hypnosis in conization are cheaper.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Procedure: General anaesthesia; Procedure: Hypnosis in conization

Detailed Description

Hypnosis in conization is more and more use to substitute General Anesthesia (GA) in Anesthesia's field. There are few studies about this new anesthesia tool. The latter showed that it's possible to substitute GA by hypnosis. This tool could have many positive such as reduced pains, anxiety or post operative vomiting nausea (POVN). Hypnosis in conization also allows time reduction in post operative security monitoring room (SSPI), speedier hospital discharge and greater patient satisfaction. Most studies involves 1 or 2 practitioners and few patients. There is no reliable research which compare Hypnosis in conization costs and GA costs. Since 2010, anesthesia's team of Grenoble Mutualist Hospital group (GHM) realized many Hypnosis in conization surgical procedures. Half of the team had been trained to Hypnosis in conization and use it for several types of surgeries for a lot of surgeons. It's the case for conisations. Currently, the 7 gynaecologists surgeons of the team achieved between 150 and 200 per year , some of this used GA, others used Hypnosis in conization, and unusually they used " rachianesthesia ". Thus, it gives us the opportunity for studying Hypnosis in conization, without practitioner effect, for a relatively cohesive group of patients (vast majority of patients are between 30 and 50 years and they haven't any particular medical history).

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38028
    • Groupe Hospitalier Mutualiste de Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

all women whom need a conization

Description

Inclusion Criteria:

• all women whom need a conization

Exclusion Criteria:

• age<18 ans
• guardianship
• trusteeship
• not affiliated to the social security

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
General anaesthesia; this group will allow us to compare the results like it is the treatment used in current practice ie general anesthesia.	Procedure: General anaesthesia; the patient will receive a general anaesthesia do proceed at her conization
Hypnosis in conization; This group is the treatment being tested , where hypnosis is used in the conization	Procedure: Hypnosis in conization; this is the experimental treatment which is allocated to the experimental group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
economic benefit of Hypnosis in conization compare to GA	The primary study endpoint will be the GA costs compare to Hypnosis in conization costs	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
time spent in the operating room	1 day
time spent in SSPI	1 day
time of participation in out-patient surgery department	1 day
hospital admission rates	1 year
postoperative pain using a visual analog scale	up to 1 month
time to resumption of professional activity	3 months
patients satisfaction using a visual analog scale	up to 1 month

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Mutualiste de Grenoble
• Investigators: Principal Investigator: Jerome Schweitzer, Physician, Groupe Hospitalier Mutualiste de Grenoble

Publications and helpful links

General Publications

• Defechereux T, Faymonville ME, Joris J, Hamoir E, Moscato A, Meurisse M. [Surgery under hypnosedation. A new therapeutic approach to hyperparathyroidism]. Ann Chir. 1998;52(5):439-43. French.
• Sefiani T, Uscain M, Sany JL, Grousseau D, Marchand P, Villate D, Vincent JL. [Laparoscopy under local anaesthesia and hypnoanaesthesia about 35 cholecystectomies and 15 inguinal hernia repair]. Ann Fr Anesth Reanim. 2004 Nov;23(11):1093-101. doi: 10.1016/j.annfar.2004.08.014. French.
• Defechereux T, Degauque C, Fumal I, Faymonville ME, Joris J, Hamoir E, Meurisse M. [[Hypnosedation, a new method of anesthesia for cervical endocrine surgery. Prospective randomized study]. Ann Chir. 2000 Jul;125(6):539-46. doi: 10.1016/s0003-3944(00)00238-8. French.
• Faymonville EM, Mambourg HP, Joris J, Vrijens B, Fissette J, Albert A, Lamy M. Psychological approaches during conscious sedation. Hypnosis versus stress reducing strategies: a prospective randomized study. Pain. 1997 Dec;73(3):361-367. doi: 10.1016/S0304-3959(97)00122-X.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2016
• Primary Completion (Actual): March 30, 2017
• Study Completion (Actual): April 30, 2017

Study Registration Dates

• First Submitted: June 3, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimate): June 14, 2016

Study Record Updates

• Last Update Posted (Actual): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Hypnosis; conization; Hypnoanesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 15-MUTG-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided