Evaluation of Medical and Economic Incidence of Hypnosis

NCT ID: NCT02799459

Last Updated: 2018-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-04

Study Completion Date

2017-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

General anaesthesia

this group will allow us to compare the results like it is the treatment used in current practice ie general anesthesia.

General anaesthesia

Intervention Type PROCEDURE

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

Hypnosis in conization

This group is the treatment being tested , where hypnosis is used in the conization

Hypnosis in conization

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

General anaesthesia

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

Intervention Type PROCEDURE

Hypnosis in conization

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* all women whom need a conization

Exclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Groupe Hospitalier Mutualiste de Grenoble

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jerome Schweitzer, Physician

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier Mutualiste de Grenoble

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 9752483 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15581727 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10986765 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9469526 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-MUTG-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hypnosis for Eye Surgery
NCT00176098 UNKNOWN PHASE1/PHASE2
Efficacy of BIS Monitoring in Deep Hypnotic State
NCT06177847 NOT_YET_RECRUITING NA
Anaesthesia and mHealth
NCT03750084 UNKNOWN