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

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 Overview

• Status: Not yet recruiting
• Conditions: Gynecological Disease
• Intervention / Treatment: Other: Hypnosis; Other: pre-surgery consultation

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jerome DELOTTE; Phone Number: +33 04 92 03 61 08; Email: delotte.j@chu-nice.fr
• Study Contact Backup: Name: Claire KOCIALKOWSKI; Phone Number: +33 0492036090; Email: kocialkowski.c@chu-nice.fr

Study Locations

• France
  • Nice, France
    • Nice University Hospital
    • Contact: Claire KOCIALKOWSKI; Phone Number: +33 0492036090; Email: kocialkowski.c@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hypnosis	Other: Hypnosis; 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.
Active Comparator: pre-surgery consultation	Other: pre-surgery consultation; 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)

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Claire KOCIALKOWSKI, Nice University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2022
• Primary Completion (Anticipated): November 15, 2023
• Study Completion (Anticipated): November 22, 2023

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: laparoscopic gynecological surgery
• Other Study ID Numbers: 21-AOI-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No