Pelvic Gynecological CancerHYPPOGYNNCT03281018
Preoperative Hypnosis in Gynecology
A study testing Caregiver Accompaniment Time (CAT) + preoperative hypnosis session in people with Pelvic Gynecological Cancer, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The research hypotheses that preoperative formal hypnosis session reduces perioperative anxiety among women undergoing a hysterectomy for pelvic gynecological cancer. The key objective is to estimate the effect of preoperative hypnosis on preoperative anxiety among this population Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Gynecological Cancer
- What is being tested?
- Caregiver Accompaniment Time (CAT) + preoperative hypnosis session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 10 Nov 2017to 26 Jun 2019
- Phase
- Interventional
- 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
- ≥ 18yrs with pelvic gynecological cancer (endometrium, cervix, ovary),
- at any stage of the disease;
- patient coming for anesthesia consultation before hysterectomy,
- informed signed consent,
- patient affiliated to or beneficiary of social security.
Who cannot join
- patient <18yrs,
- patient with a pelvic gynecological cancer that does not require hysterectomy;
- patient with psychiatric history or a depressive syndrome;
- deaf patient (deafness makes the hypnosis session impossible),
- patient under legal protection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study of the Impact of a Preoperative Formal Hypnosis Session on Perioperative Anxiety Among Female Patients Hospitalised for Hysterectomy Due to Pelvic Gynecological Cancer
The research hypotheses that preoperative formal hypnosis session reduces perioperative anxiety among women undergoing a hysterectomy for pelvic gynecological cancer. The key objective is to estimate the effect of preoperative hypnosis on preoperative anxiety among this population
Read the detailed description
Anxiety is present preoperatively in 40% of patients. The operated subjects are on average 20% more anxious than the general population, according to a study of 2013. Cancer as well as surgery modifying the body pattern and impairing femininity are risk factors for preoperative anxiety. Recent work in both children and adults has shown that significant levels of preoperative anxiety increase the risk of postoperative complications and the occurrence of postoperative emotional and behavioral disorders. The consequences of hysterectomy increase patients' anxiety, for fear of affecting femininity, and the modification of the body regimen. The prevention of preoperative anxiety in such population is therefore a major issue.
- Conditions
- Pelvic Gynecological Cancer
- Being tested
- Caregiver Accompaniment Time (CAT) + preoperative hypnosis session
- Keywords
- hypnosis, preoperative anxiety, hysterectomy, hospitalisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver Accompaniment Time (CAT) + preoperative hypnosis sessionBehavioural
The hypnosis session is performed by a nurse trained in medical hypnosis; this interview lasts approximately one hour and is carried out 5 to 15 days before the hospitalisation. During the hypnosis session, the patient is free to choose what issues she wants to address. The patient will then go from a state of ordinary consciousness to a modified state of consciousness. This state will allow her to activate her own resources to handle difficulties, especially anxiety. Using a post-hypnotic suggestion, the patient will be able to revisit her work at any time she needs
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Caregiver Accompaniment Time (CAT) + preoperative hypnosis session (experimental arm): The hypnosis session is performed by a nurse trained in medical hypnosis; this interview lasts approximately one hour and is carried out 5 to 15 days before the hospitalisation. During the hypnosis session, the patient is free to choose what issues she wants to address. The patient will then go from a state of ordinary consciousness to a modified state of consciousness. This state will allow her to activate her own resources to handle difficulties, especially anxiety. Using a post-hypnotic suggestion, the patient will be able to revisit her work at any time she needs Receives: Behavioral: Caregiver Accompaniment Time (CAT) + preoperative hypnosis session |
| Control (CAT) | No intervention | CAT is performed in routine care for all patients after the announcement of the illness by a trained nurse, if possible on the same day as the consultation or before the consultation of anesthesia. This is an interview of approximately 45 minutes to listen to the patient, to answer her questions and to re-explain the information delivered to her. The patient will tackle the history of the disease and then the treatment, this time dedicated evolves according to the desire of the patient and her ability to accept the disease. The patient can express her feelings, then the family circle is evoked talking about the resource persons and the future. The purpose of this interview is to obtain the autonomy of the patient by the setting up of supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
evolution of anxiety
visual analog scale (from 0, no anxiety to 10, extreme anxiety)
Measured: 1 month after the surgery
Secondary outcomes (6)
pain
numerical scale of pain (from 0, no pain, to 10, extreme pain)
Measured: The day of the consultation with anesthesist, the day before the surgery, 2 days, an average of 12 days, and 1 month after the surgery
nausea and vomiting
frequency and intensity through an interview with a nurse
Measured: 2 days, an average of 12 days, and 1 month after the surgery
concomitant medication
concomitant medication within anxiolytic, antalgic, and/or antiemetic pharmaceutical classes (yes/no)
Measured: The day of the consultation with anesthesist, the day before the surgery, 2 days, an average of 12 days, and 1 month after the surgery
medical history
chronic pathologies (e.g. arterial hypertension, type 2 diabetes) (yes/no)
Measured: The day of the consultation with anesthesist
length of hospital stay
Measured: an average of 12 days after the surgery
hypnosis intervention feasibility (composite outcome)
Compliance with the formal Hypnosis session checklist (Installation, pre-session interview, kinesthetic induction, dissociation, deepening, post-hypnotic suggestions and anchoring, return to normal wakefulness)
Other factors: proportion of refusals, proportion of abandoned, proportion of lost sight
Measured: after the hypnosis session (average of 1 week before the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start10 Nov 2017
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Gynecological CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennie SOURZAC, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281018
- Sponsor's protocol ID
- CHUBX 2016/18
- Other IDs
- 2017-A00084-49
- Acronym
- HYPPOGYN
- Status last verified
- Jul 2019
- First submitted
- 1 Sep 2017
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sourzac J, Berger V, Conri V. [The impact of conversational hypnosis on the pre- and postoperative anxiety of patients in gynecological surgery versus ordinary practice: A comparative study]. Rech Soins Infirm. 2018 Dec;(135):83-90. doi: 10.3917/rsi.135.0083. French.
PubMed 30767472
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of the Impact of a Preoperative Formal Hypnosis Session on Perioperative Anxiety Among Female Patients Hospitalised for Hysterectomy Due to Pelvic Gynecological Cancer
- ClinicalTrials.gov ID
- NCT03281018
- Acronym / sponsor ID
- HYPPOGYN / CHUBX 2016/18
- Conditions
- Pelvic Gynecological Cancer
- Keywords
- hypnosis, preoperative anxiety, hysterectomy, hospitalisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 13 Sep 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 research hypotheses that preoperative formal hypnosis session reduces perioperative anxiety among women undergoing a hysterectomy for pelvic gynecological cancer. The key objective is to estimate the effect of preoperative hypnosis on preoperative anxiety among this population
Detailed description
Anxiety is present preoperatively in 40% of patients. The operated subjects are on average 20% more anxious than the general population, according to a study of 2013. Cancer as well as surgery modifying the body pattern and impairing femininity are risk factors for preoperative anxiety. Recent work in both children and adults has shown that significant levels of preoperative anxiety increase the risk of postoperative complications and the occurrence of postoperative emotional and behavioral disorders. The consequences of hysterectomy increase patients' anxiety, for fear of affecting femininity, and the modification of the body regimen. The prevention of preoperative anxiety in such population is therefore a major issue.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Behavioral: Caregiver Accompaniment Time (CAT) + preoperative hypnosis sessionCaregiver Accompaniment Time (CAT) + preoperative hypnosis session (experimental arm): The hypnosis session is performed by a nurse trained in medical hypnosis; this interview lasts approximately one hour and is carried out 5 to 15 days before the hospitalisation. During the hypnosis session, the patient is free to choose what issues she wants to address. The patient will then go from a state of ordinary consciousness to a modified state of consciousness. This state will allow her to activate her own resources to handle difficulties, especially anxiety. Using a post-hypnotic suggestion, the patient will be able to revisit her work at any time she needs |
| Control (CAT) | No intervention | –CAT is performed in routine care for all patients after the announcement of the illness by a trained nurse, if possible on the same day as the consultation or before the consultation of anesthesia. This is an interview of approximately 45 minutes to listen to the patient, to answer her questions and to re-explain the information delivered to her. The patient will tackle the history of the disease and then the treatment, this time dedicated evolves according to the desire of the patient and her ability to accept the disease. The patient can express her feelings, then the family circle is evoked talking about the resource persons and the future. The purpose of this interview is to obtain the autonomy of the patient by the setting up of supportive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18yrs with pelvic gynecological cancer (endometrium, cervix, ovary),
- at any stage of the disease;
- patient coming for anesthesia consultation before hysterectomy,
- informed signed consent,
- patient affiliated to or beneficiary of social security.
Key exclusion criteria (5 listed)
- patient <18yrs,
- patient with a pelvic gynecological cancer that does not require hysterectomy;
- patient with psychiatric history or a depressive syndrome;
- deaf patient (deafness makes the hypnosis session impossible),
- patient under legal protection.
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 |
|---|---|---|
| Caregiver Accompaniment Time (CAT) + preoperative hypnosis sessionThe hypnosis session is performed by a nurse trained in medical hypnosis; this interview lasts approximately one hour and is carried out 5 to 15 days before the hospitalisation. During the hypnosis session, the patient is free to choose what issues she wants to address. The patient will then go from a state of ordinary consciousness to a modified state of consciousness. This state will allow her to activate her own resources to handle difficulties, especially anxiety. Using a post-hypnotic suggestion, the patient will be able to revisit her work at any time she needs | Behavioural | Interventional arm |
Primary outcome
evolution of anxiety
Time frame: 1 month after the surgery
visual analog scale (from 0, no anxiety to 10, extreme anxiety)
6 secondary outcomes
pain
Time frame: The day of the consultation with anesthesist, the day before the surgery, 2 days, an average of 12 days, and 1 month after the surgery
nausea and vomiting
Time frame: 2 days, an average of 12 days, and 1 month after the surgery
concomitant medication
Time frame: The day of the consultation with anesthesist, the day before the surgery, 2 days, an average of 12 days, and 1 month after the surgery
medical history
Time frame: The day of the consultation with anesthesist
length of hospital stay
Time frame: an average of 12 days after the surgery
hypnosis intervention feasibility (composite outcome)
Time frame: after the hypnosis session (average of 1 week before the surgery)
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 14 May 2026.
- Results publication: PubMed 30767472Sourzac J, Berger V, Conri V. [The impact of conversational hypnosis on the pre- and postoperative anxiety of patients in gynecological surgery versus ordinary practice: A comparative study]. Rech Soins Infirm. 2018 Dec;(135):83-90. doi: 10.3917/rsi.135.0083. French.
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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.
Jennie SOURZAC principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver Accompaniment Time (CAT) + preoperative hypnosis session in people with Pelvic Gynecological Cancer, run by University Hospital, Bordeaux 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 5 inclusion and 5 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 14 May 2026. 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?
evolution of anxiety (time frame: 1 month after the surgery). 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 NCT03281018, which also lists 1 linked publication.
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 14 May 2026.