NCT02799459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

June 3, 2016

Last Update Submit

July 31, 2018

Conditions

Surgery

Keywords

HypnoanesthesiaHypnosisconization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • time spent in the operating room

    1 day

  • time spent in SSPI

    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

  • +2 more secondary outcomes

Study Arms (2)

General anaesthesia

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

Procedure: General anaesthesia

Hypnosis in conization

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

Procedure: Hypnosis in conization

Interventions

General anaesthesiaPROCEDURE

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

General anaesthesia
Hypnosis in conizationPROCEDURE

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

Hypnosis in conization

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all women whom need a conization

You may qualify if:

  • all women whom need a conization

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38028, France

Location

Related Publications (4)

  • 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.

    PMID: 9752483BACKGROUND

  • 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.

    PMID: 15581727BACKGROUND

  • 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.

    PMID: 10986765BACKGROUND

  • 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.

    PMID: 9469526BACKGROUND

MeSH Terms

Interventions

Anesthesia, GeneralHypnosisConization

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jerome Schweitzer, Physician

    Groupe Hospitalier Mutualiste de Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2016

First Posted

June 14, 2016

Study Start

January 4, 2016

Primary Completion

March 30, 2017

Study Completion

April 30, 2017

Last Updated

August 1, 2018

Record last verified: 2018-07

Locations

FR(1)