Clinical trial NCT02799459: Evaluation of Medical and Economic Incidence of Hypnosis
Official title: Evaluation of Medical and Economic Incidence of Hypnosis in Conization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: Hypnoanesthesia
Hypnosis
conization
Lead sponsor: Groupe Hospitalier Mutualiste de Grenoble
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all women whom need a conization

Brief summary: 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.

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).

Eligibility criteria: Inclusion Criteria:

* all women whom need a conization

Exclusion Criteria:

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

Primary outcomes:
measure: economic benefit of Hypnosis in conization compare to GA
timeFrame: 1 month
Secondary outcomes:
measure: time spent in the operating room
timeFrame: 1 day
measure: time spent in SSPI
timeFrame: 1 day
measure: time of participation in out-patient surgery department
timeFrame: 1 day
measure: hospital admission rates
timeFrame: 1 year
measure: postoperative pain using a visual analog scale
timeFrame: up to 1 month
measure: time to resumption of professional activity
timeFrame: 3 months
measure: patients satisfaction using a visual analog scale
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble
Study officials:
affiliation: Groupe Hospitalier Mutualiste de Grenoble
name: Jerome Schweitzer, Physician
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.