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Completed

NCT Number: NCT02799459

Evaluation of Medical and Economic Incidence of Hypnosis

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38028, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • all women whom need a conization

Exclusion criteria

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

Treatment and study plan

General anaesthesia

Procedure

the patient will receive a general anaesthesia do proceed at her conization

Hypnosis in conization

Procedure

this is the experimental treatment which is allocated to the experimental group

Primary outcomes

  1. 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

  1. time spent in the operating room

    Time frame: 1 day

  2. time spent in SSPI

    Time frame: 1 day

  3. time of participation in out-patient surgery department

    Time frame: 1 day

  4. hospital admission rates

    Time frame: 1 year

  5. postoperative pain using a visual analog scale

    Time frame: up to 1 month

  6. time to resumption of professional activity

    Time frame: 3 months

  7. patients satisfaction using a visual analog scale

    Time frame: up to 1 month

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Mutualiste de Grenoble

Other

Registry information

Official study title

Evaluation of Medical and Economic Incidence of Hypnosis in Conization

Acronym: HYPNONISAT°

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 14, 2016
Registry last updated
Aug 1, 2018

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.

Published trials that share one or more normalized conditions with this study.