Improved Rehabilitation After Surgery and Hypnosis: Benefits Potentiated by a Preoperative Consultation

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Improved Rehabilitation After Surgery and Hypnosis: Benefits Potentiated by a Preoperative Consultation

Conditions
-----------------
Gynecological Disease

Intervention / Treatment
-----------------
* Other: Hypnosis
* Other: pre-surgery consultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypnosis<br> | Other: Hypnosis<br>* 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.<br>|
| Active Comparator: pre-surgery consultation<br> | Other: pre-surgery consultation<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 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. | Day 7 of the discharge from hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic gynecological surgery