Evaluation of Medical and Economic Incidence of Hypnosis

Completed

• Conditions: Surgery

• Registration Number: NCT02799459
• Lead Sponsor: Groupe Hospitalier Mutualiste de Grenoble

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).

Study Timeline

• Study Start: 2016-01-04
• Study First Submitted: 2016-06-03
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-14
• Primary Completion: 2017-03-30
• Study Completion: 2017-04-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• all women whom need a conization

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
economic benefit of Hypnosis in conization compare to GA	1 month	The primary study endpoint will be the GA costs compare to Hypnosis in conization costs

Secondary Outcome Measures

Name	Time	Method
time to resumption of professional activity	3 months
time spent in the operating room	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
patients satisfaction using a visual analog scale	up to 1 month
time spent in SSPI	1 day

Trial Locations

Locations (1)

Groupe Hospitalier Mutualiste de Grenoble; 🇫🇷 Grenoble, France