Gynecological DiseaseRACHYPNCT05276882
Improved Rehabilitation After Surgery and Hypnosis: Benefits Potentiated by a Preoperative Consultation
A study testing Hypnosis and pre-surgery consultation in people with Gynecological Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Today, patient management in the context of scheduled surgery must meet new requirements. The understanding of surgical aggression, the evolution of anesthesia and surgery techniques have allowed the birth of the protocol of Improved Rehabilitation After Surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecological Disease
- What is being tested?
- Hypnosis and pre-surgery consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2022to 19 Jul 2024
- 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
- Female gender
- Age ≥ 18 years
- Indication for laparoscopic gynecological surgery eligible for the Improved Rehabilitation After Surgery protocol
- Understanding of French essential
- Signature of informed consent
- Affiliation to a Social Security system
Who cannot join
- Patient with a history of psychiatric pathologies (Schizophrenia, Psychosis, Bipolarity)
- Deafness, intellectual deficiency not allowing comprehension
- Pregnant or breastfeeding women
- Women of childbearing age who are not using an effective method of contraception (pill, intrauterine device, vaginal ring, contraceptive skin patch, subcutaneous hormonal implant, surgical sterilization)
- Patient under guardianship or deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Today, patient management in the context of scheduled surgery must meet new requirements. The understanding of surgical aggression, the evolution of anesthesia and surgery techniques have allowed the birth of the protocol of Improved Rehabilitation After Surgery. The objective is a pain-free surgery, with a minimum of risks, with a global management of the patient and an active participation.
In 2019, the Nice University Hospital developed this program. Other non-medicinal techniques could promote the evolution of this program such as integrative medicine with, in this study case, hypnosis. Since 2002, thanks to its widely recognized effectiveness in the treatment of pain and in helping with care, its use has developed. A hypnosis session, proposed in the preoperative period, would considerably reduce the patient's anxiety, postoperative pain, a better and faster recovery with an easier healing: objectives of the Improved Rehabilitation After Surgery program. The patient's satisfaction would also be improved thanks to his active participation, in a greater comfort, which the investigators want to demonstrate by our work.
- Conditions
- Gynecological Disease
- Being tested
- Hypnosis, pre-surgery consultation
- Keywords
- laparoscopic gynecological 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.
HypnosisOther
It will be an individualized hypnosis session of Ericksonian type. It consists in going through 3 phases: induction, dissociation, suggestion.
The principle is to focus the patient's attention by talking to her or by surprising her, or by making her do an incongruous gesture which will make her focus on a restricted idea. She will reduce her field of consciousness and concentrate. This is where her work will begin, allowing her unconscious to function in order to find her solutions. At this moment, she is particularly receptive to suggestions and the hypnotherapist accompanies and guides her thoughts and her associations of ideas on therapeutic paths. He provokes a unique personal work which aims to promote healing.
pre-surgery consultationOther
Dialogue with the patient to clarify her expectations.
- Answers to the patient's questions
- Precision on the organization of the hospitalization if necessary
- Information on the postoperative period with postural advice to facilitate the first getting up with less discomfort, and postures promoting rest in the postoperative period
- Information on relaxation techniques and their interest (abdominal breathing)
| Study group | Role | What they receive |
|---|---|---|
| hypnosis | Experimental | Not described Receives: Other: Hypnosis |
| pre-surgery consultation | Active comparator | Not described Receives: Other: pre-surgery consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient anxiety
Evolution of the patient's anxiety between the initial consultation and the day of the surgery.
Anxiety will be measured using the Spielberger State Trait Anxiety Inventory (S.T.A.I.) To obtain the state-anxiety score, the scores obtained for the 20 items corresponding to the state-anxiety (items 1 to 20) are added together. If two or more items are not answered, the questionnaire cannot be used.
The mean score for women in non-anxiety situations was 47.13 with a standard deviation of 10. A score higher than this indicates an anxious state.
Very high score > 65 High score = 56 to 65 Average score= 46 to 55 Low score=36 to 45 Very low score < or = 35
Measured: Up to 2 months
Secondary outcomes (4)
Patient satisfaction
Patient satisfaction will be assessed using the Enhanced Rehabilitation After Surgery protocol satisfaction questionnaire The questionnaire is composed of 9 questions exploring the patient's general feeling about her care, the clarity of the information received, pain, the Enhanced Rehabilitation After Surgery protocol
Measured: day of discharge from hospital, average of 7 days
length of stay in hospital
length of stay in hospital defined as the number of days between the day of surgery and discharge
Measured: the day of discharge from hospital, average of 7 days
use of injectable analgesic
Comparison of the number of patients having had an injectable analgesic prescription between Day 1 and Day 7 of the surgery (binary yes/no criterion).
This evaluation is only relevant from Day 1 onwards, because at Day 0 it is very common to have to resort to parenteral analgesia.
Measured: Day 7 of the surgery
speed of cicatrization
The speed of cicatrization will be evaluated in the postoperative period by means of the patient's logbook, which evaluates the evolution of the wound from day 2.
The wound will be considered healed as soon as the patient answers that the dressing is clean.
Measured: Day 7 of the discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start8 Dec 2022
- Primary completion19 Jul 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire KOCIALKOWSKI, Principal investigator, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276882
- Sponsor's protocol ID
- 21-AOI-08
- Acronym
- RACHYP
- Status last verified
- Oct 2024
- First submitted
- 17 Feb 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Rehabilitation After Surgery and Hypnosis: Benefits Potentiated by a Preoperative Consultation
- ClinicalTrials.gov ID
- NCT05276882
- Acronym / sponsor ID
- RACHYP / 21-AOI-08
- Conditions
- Gynecological Disease
- Keywords
- laparoscopic gynecological surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 11 Mar 2022 (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.
Today, patient management in the context of scheduled surgery must meet new requirements. The understanding of surgical aggression, the evolution of anesthesia and surgery techniques have allowed the birth of the protocol of Improved Rehabilitation After Surgery. The objective is a pain-free surgery, with a minimum of risks, with a global management of the patient and an active participation.
In 2019, the Nice University Hospital developed this program. Other non-medicinal techniques could promote the evolution of this program such as integrative medicine with, in this study case, hypnosis. Since 2002, thanks to its widely recognized effectiveness in the treatment of pain and in helping with care, its use has developed. A hypnosis session, proposed in the preoperative period, would considerably reduce the patient's anxiety, postoperative pain, a better and faster recovery with an easier healing: objectives of the Improved Rehabilitation After Surgery program. The patient's satisfaction would also be improved thanks to his active participation, in a greater comfort, which the investigators want to demonstrate by our work.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypnosis | Experimental | Other: Hypnosis |
| pre-surgery consultation | Active comparator | Other: pre-surgery consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female gender
- Age ≥ 18 years
- Indication for laparoscopic gynecological surgery eligible for the Improved Rehabilitation After Surgery protocol
- Understanding of French essential
- Signature of informed consent
Key exclusion criteria (5 listed)
- Patient with a history of psychiatric pathologies (Schizophrenia, Psychosis, Bipolarity)
- Deafness, intellectual deficiency not allowing comprehension
- Pregnant or breastfeeding women
- Women of childbearing age who are not using an effective method of contraception (pill, intrauterine device, vaginal ring, contraceptive skin patch, subcutaneous hormonal implant, surgical sterilization)
- Patient under guardianship or deprived of liberty
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 |
|---|---|---|
| HypnosisIt will be an individualized hypnosis session of Ericksonian type. It consists in going through 3 phases: induction, dissociation, suggestion. The principle is to focus the patient's attention by talking to her or by surprising her, or by making her do an incongruous gesture which will make her focus on a restricted idea. She will reduce her field of consciousness and concentrate. This is where her work will begin, allowing her unconscious to function in order to find her solutions. At this moment, she is particularly receptive to suggestions and the hypnotherapist accompanies and guides her thoughts and her associations of ideas on therapeutic paths. He provokes a unique personal work which aims to promote healing. | Other | hypnosis |
| pre-surgery consultationDialogue with the patient to clarify her expectations. * Answers to the patient's questions * Precision on the organization of the hospitalization if necessary * Information on the postoperative period with postural advice to facilitate the first getting up with less discomfort, and postures promoting rest in the postoperative period * Information on relaxation techniques and their interest (abdominal breathing) | Other | pre-surgery consultation |
Primary outcome
Patient anxiety
Time frame: Up to 2 months
Evolution of the patient's anxiety between the initial consultation and the day of the surgery. Anxiety will be measured using the Spielberger State Trait Anxiety Inventory (S.T.A.I.) To obtain the state-anxiety score, the scores obtained for the 20 items corresponding to the state-anxiety (items 1 to 20) are added together. If two or more items are not answered, the questionnaire cannot be used. The mean score for women in non-anxiety situations was 47.13 with a standard deviation of 10. A score higher than this indicates an anxious state. Very high score > 65 High score = 56 to 65 Average score= 46 to 55 Low score=36 to 45 Very low score < or = 35
4 secondary outcomes
Patient satisfaction
Time frame: day of discharge from hospital, average of 7 days
length of stay in hospital
Time frame: the day of discharge from hospital, average of 7 days
use of injectable analgesic
Time frame: Day 7 of the surgery
speed of cicatrization
Time frame: Day 7 of the discharge from hospital
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 15 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Gynecological Disease
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
Methylation Analyses for Gynaecological Research Through Home-based Self-sampling
Healthy Adult Participants, Gynecological Disease
RecruitingObservational study
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
GYN Disorders
Active, not recruitingPhase 2
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Ovarian Neoplasms, Endometrial Neoplasms
Active, not recruitingObservational study
Diet, Hepcidin, and Chemotherapy RDI
Breast Cancer Female, Ovarian Cancer
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.
Claire KOCIALKOWSKI principal investigator
Nice University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis and pre-surgery consultation in people with Gynecological Disease, run by Centre Hospitalier Universitaire de Nice 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 6 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 15 Oct 2024. 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?
Patient anxiety (time frame: Up to 2 months). 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 15 Oct 2024.