Evaluation of Medical and Economic Incidence of Hypnosis

Surgery Clinical Trial

— HYPNONISAT°  

Official title:

Evaluation of Medical and Economic Incidence of Hypnosis in Conization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799459
• Other study ID #: 15-MUTG-01
• Status: Completed
• Start date: January 4, 2016
• Est. completion date: April 30, 2017

Study information

• Verified date: July 2018
• Source: Groupe Hospitalier Mutualiste de Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 30, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all women whom need a conization

Exclusion Criteria:

• age<18 ans

• guardianship

• trusteeship

• not affiliated to the social security

Related Conditions & MeSH terms

• Surgery

Intervention

Procedure:
• General anaesthesia
the patient will receive a general anaesthesia do proceed at her conization
• Hypnosis in conization
this is the experimental treatment which is allocated to the experimental group

Locations

Country	Name	City	State
France	Groupe Hospitalier Mutualiste de Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Mutualiste de Grenoble

Country where clinical trial is conducted

France, 

References & Publications (4)

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. French. — View 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. — View Citation

Faymonville ME, Mambourg PH, 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):361-7. — View Citation

Séfiani 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. French. — View Citation

Outcome

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