Gynecologic DiseasePhase 4HYPNOGYNNCT03327506
Preoperative Hypnosis Versus Premedication in Gynecological Surgery
A Phase 4 study testing Alprazolam 0.5 mg in people with Gynecologic Disease and Anxiety Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The aim of this study is to evaluate the efficacy of an hypnosis session, performed on the eve of a laparoscopic gynecological surgery, on the level of immediate preoperative anxiety measured by State-Trait Anxiety Index (STAI-Y) self-administered questionnaire compared to premedication by alprazolam®. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Disease, Anxiety Disease
- What is being tested?
- Alprazolam 0.5 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2018to Dec 2021
- Phase
- Phase 4
- 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
Who may be able to join
- Patient's age: over 18 years
- Patient care and follow-up at the regional maternity center of Nancy (CHRU of Nancy)
- Female patient for whom gynecological laparoscopic surgery is programmed and lasting longer than 1 hour (ovarian cyst, laparoscopy infertility, laparoscopic promontofixation, noncarcinogenic assisted laparoscopy hysterectomy, endometriosis, diagnostic laparoscopy, pyosalpinx, hydrosalpinx)
- Patient with Physical status score (ASA) score between 1 and 3
- With standardized anesthesia protocol
- Patient affiliated to a Social Security
- Patient has received complete information about the organization of the research and has signed her informed consent
Who cannot join
- Pretreatment by benzodiazepines
- Known hypersensitivity to Alprazolam® (including undocumented)
- Prohibition conditions to Alprazolam®: Severe respiratory insufficiency, Sleep apnea syndrome, Myasthenia, Severe acute or chronic hepatic impairment
- Ongoing major depressive episode
- Chronic use (> 1 month) of benzodiazepines or morphine or analgesics of level 2
- Participation in a therapeutic trial 6 months before inclusion in this trial
- Patient referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Florence Vial
Nancy, 54000
FLORENCE VIAL, DR, 0033383944490, f.vial@chu-nancy.fr
FLORENCE vial, dr
About this study
Official title: Efficacity of Hypnosis Versus Premedication for the Management of Perioperative Anxiety in Gynecological Surgery
The aim of this study is to evaluate the efficacy of an hypnosis session, performed on the eve of a laparoscopic gynecological surgery, on the level of immediate preoperative anxiety measured by State-Trait Anxiety Index (STAI-Y) self-administered questionnaire compared to premedication by alprazolam®.
- Conditions
- Gynecologic Disease, Anxiety Disease
- Being tested
- Alprazolam 0.5 mg
- Keywords
- Premedication/ Hypnosis/ Anxiety/Surgery
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alprazolam 0.5 mgDrug
Also called hypnosis
alprazolam 0,5 mg the eve and the morning of the surgery versus a preoperative hypnosis session
| Study group | Role | What they receive |
|---|---|---|
| hypnosis group | Experimental | Intervention: hypnosis session the eve of the surgery Receives: Drug: Alprazolam 0.5 mg |
| premedication | Active comparator | alprazolam 0,5 mg the eve and the morning of the surgery Receives: Drug: Alprazolam 0.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety score evaluated by STAI-Y
evaluated by STAI-Y self-administered questionary
Measured: before surgery (day 2_before)
Secondary outcomes (8)
Anxiety score evaluated by analogue visual scale
evaluated by analogue visual scale (EVA 0 to 10)
Measured: at inclusion visit (day 1), before surgery (day 2_before), after surgery (day 2_after), 24 h after the surgery (day 3)
sleep quality evaluated by EVA scale
evaluated by EVA scale (0 to 10)
Measured: day 2_before and the day 3
patient satisfaction score evaluated by EVA scale
evaluated by EVA scale (0 to 10)
Measured: day 3
analysis of salivary amylase
salivary amylase
Measured: day 1 and day2_before
postoperative fatigue evaluated by EVA scale
evaluated by EVA scale (0 to 10)
Measured: day 3
Intraoperative morphine and hypnotics drugs Consumption
Consumption
Measured: day 3
Incidence of nausea and vomiting
Incidence
Measured: day 3
Score of pain measured by EVA scale
measured by EVA (0 to 10)
Measured: day 2_after, day 2_recovery room (at the end of recovery room) and Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start27 Nov 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327506
- Sponsor's protocol ID
- 2017-002112-13
- Other IDs
- 2017
- Acronym
- HYPNOGYN
- Status last verified
- Feb 2021
- First submitted
- 17 Oct 2017
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacity of Hypnosis Versus Premedication for the Management of Perioperative Anxiety in Gynecological Surgery
- ClinicalTrials.gov ID
- NCT03327506
- Acronym / sponsor ID
- HYPNOGYN / 2017-002112-13
- Conditions
- Gynecologic Disease, Anxiety Disease
- Keywords
- Premedication/ Hypnosis/ Anxiety/Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 31 Oct 2017 (actual)
- 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.
The aim of this study is to evaluate the efficacy of an hypnosis session, performed on the eve of a laparoscopic gynecological surgery, on the level of immediate preoperative anxiety measured by State-Trait Anxiety Index (STAI-Y) self-administered questionnaire compared to premedication by alprazolam®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypnosis group | Experimental | Drug: Alprazolam 0.5 mgIntervention: hypnosis session the eve of the surgery |
| premedication | Active comparator | Drug: Alprazolam 0.5 mgalprazolam 0,5 mg the eve and the morning of the surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient's age: over 18 years
- Patient care and follow-up at the regional maternity center of Nancy (CHRU of Nancy)
- Female patient for whom gynecological laparoscopic surgery is programmed and lasting longer than 1 hour (ovarian cyst, laparoscopy infertility, laparoscopic promontofixation, noncarcinogenic assisted laparoscopy hysterectomy, endometriosis, diagnostic laparoscopy, pyosalpinx, hydrosalpinx)
- Patient with Physical status score (ASA) score between 1 and 3
- With standardized anesthesia protocol
Key exclusion criteria (7 listed)
- Pretreatment by benzodiazepines
- Known hypersensitivity to Alprazolam® (including undocumented)
- Prohibition conditions to Alprazolam®: Severe respiratory insufficiency, Sleep apnea syndrome, Myasthenia, Severe acute or chronic hepatic impairment
- Ongoing major depressive episode
- Chronic use (> 1 month) of benzodiazepines or morphine or analgesics of level 2
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 |
|---|---|---|
| Alprazolam 0.5 mgAlso: hypnosisalprazolam 0,5 mg the eve and the morning of the surgery versus a preoperative hypnosis session | Drug | hypnosis group, premedication |
Primary outcome
Preoperative Anxiety score evaluated by STAI-Y
Time frame: before surgery (day 2_before)
evaluated by STAI-Y self-administered questionary
8 secondary outcomes
Anxiety score evaluated by analogue visual scale
Time frame: at inclusion visit (day 1), before surgery (day 2_before), after surgery (day 2_after), 24 h after the surgery (day 3)
sleep quality evaluated by EVA scale
Time frame: day 2_before and the day 3
patient satisfaction score evaluated by EVA scale
Time frame: day 3
analysis of salivary amylase
Time frame: day 1 and day2_before
postoperative fatigue evaluated by EVA scale
Time frame: day 3
Intraoperative morphine and hypnotics drugs Consumption
Time frame: day 3
Incidence of nausea and vomiting
Time frame: day 3
Score of pain measured by EVA scale
Time frame: day 2_after, day 2_recovery room (at the end of recovery room) and Day 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alprazolam 0.5 mg in people with Gynecologic Disease and Anxiety Disease, run by Central Hospital, Nancy, France 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Feb 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact florence vial (0033610405237, f.vial@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Anxiety score evaluated by STAI-Y (time frame: before surgery (day 2_before)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2021.