SurgeryHYPNONISAT°NCT02799459
Evaluation of Medical and Economic Incidence of Hypnosis
An observational study of Surgery, run by Groupe Hospitalier Mutualiste de Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgery
- What is being tested?
- General anaesthesia and Hypnosis in conization
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2016to 30 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: all women whom need a conization
Who may be able to join
- all women whom need a conization
Who cannot join
- age<18 ans
- guardianship
- trusteeship
- not affiliated to the social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Medical and Economic Incidence of Hypnosis in Conization
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.
Read the 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).
- Conditions
- Surgery
- Being tested
- General anaesthesia, Hypnosis in conization
- Keywords
- Hypnoanesthesia, Hypnosis, conization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anaesthesiaProcedure or surgery
the patient will receive a general anaesthesia do proceed at her conization
Hypnosis in conizationProcedure or surgery
this is the experimental treatment which is allocated to the experimental group
| Study group | Role | What they receive |
|---|---|---|
| General anaesthesia | this group will allow us to compare the results like it is the treatment used in current practice ie general anesthesia. Receives: Procedure: General anaesthesia | |
| Hypnosis in conization | This group is the treatment being tested , where hypnosis is used in the conization Receives: Procedure: Hypnosis in conization |
What is being measured
The primary outcome is the main question the study is designed to answer.
economic benefit of Hypnosis in conization compare to GA
The primary study endpoint will be the GA costs compare to Hypnosis in conization costs
Measured: 1 month
Secondary outcomes (7)
time spent in the operating room
Measured: 1 day
time spent in SSPI
Measured: 1 day
time of participation in out-patient surgery department
Measured: 1 day
hospital admission rates
Measured: 1 year
postoperative pain using a visual analog scale
Measured: up to 1 month
time to resumption of professional activity
Measured: 3 months
patients satisfaction using a visual analog scale
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start4 Jan 2016
- Primary completion30 Mar 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Mutualiste de Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerome Schweitzer, Physician, Principal investigator, Groupe Hospitalier Mutualiste de Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799459
- Sponsor's protocol ID
- 15-MUTG-01
- Acronym
- HYPNONISAT°
- Status last verified
- Jul 2018
- First submitted
- 3 Jun 2016
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 9752483Sefiani 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.
PubMed 15581727Defechereux 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.
PubMed 10986765Faymonville 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.
PubMed 9469526
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Medical and Economic Incidence of Hypnosis in Conization
- ClinicalTrials.gov ID
- NCT02799459
- Acronym / sponsor ID
- HYPNONISAT° / 15-MUTG-01
- Conditions
- Surgery
- Keywords
- Hypnoanesthesia, Hypnosis, conization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Groupe Hospitalier Mutualiste de GrenobleUniversity, hospital or other
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anaesthesia | – | Procedure: General anaesthesiathis group will allow us to compare the results like it is the treatment used in current practice ie general anesthesia. |
| Hypnosis in conization | – | Procedure: Hypnosis in conizationThis group is the treatment being tested , where hypnosis is used in the conization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all women whom need a conization
Key inclusion criteria (1 listed)
- all women whom need a conization
Key exclusion criteria (4 listed)
- age<18 ans
- guardianship
- trusteeship
- not affiliated to the social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anaesthesiathe patient will receive a general anaesthesia do proceed at her conization | Procedure or surgery | General anaesthesia |
| Hypnosis in conizationthis is the experimental treatment which is allocated to the experimental group | Procedure or surgery | Hypnosis in conization |
Primary outcome
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
7 secondary outcomes
time spent in the operating room
Time frame: 1 day
time spent in SSPI
Time frame: 1 day
time of participation in out-patient surgery department
Time frame: 1 day
hospital admission rates
Time frame: 1 year
postoperative pain using a visual analog scale
Time frame: up to 1 month
time to resumption of professional activity
Time frame: 3 months
patients satisfaction using a visual analog scale
Time frame: up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Background: PubMed 9752483Defechereux 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.
- Background: PubMed 15581727Sefiani 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.
- Background: PubMed 10986765Defechereux 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.
- Background: PubMed 9469526Faymonville 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerome Schweitzer, Physician principal investigator
Groupe Hospitalier Mutualiste de Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Groupe Hospitalier Mutualiste de Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
economic benefit of Hypnosis in conization compare to GA (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02799459, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.