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Clinical Trials/NCT02799459
NCT02799459
Completed
Not Applicable

Evaluation of Medical and Economic Incidence of Hypnosis in Conization

Groupe Hospitalier Mutualiste de Grenoble1 site in 1 country140 target enrollmentJanuary 4, 2016
ConditionsSurgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Groupe Hospitalier Mutualiste de Grenoble
Enrollment
140
Locations
1
Primary Endpoint
economic benefit of Hypnosis in conization compare to GA
Status
Completed
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 4, 2016
End Date
April 30, 2017
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Groupe Hospitalier Mutualiste de Grenoble
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • all women whom need a conization

Exclusion Criteria

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

Outcomes

Primary Outcomes

economic benefit of Hypnosis in conization compare to GA

Time Frame: 1 month

The primary study endpoint will be the GA costs compare to Hypnosis in conization costs

Secondary Outcomes

  • 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)

Study Sites (1)

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