Clinical trial NCT05276882: Improved Rehabilitation After Surgery and Hypnosis: Benefits Potentiated by a Preoperative Consultation
Official title: Improved Rehabilitation After Surgery and Hypnosis: Benefits Potentiated by a Preoperative Consultation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecological Disease
Keywords: laparoscopic gynecological surgery
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Patient anxiety
timeFrame: Up to 2 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: day of discharge from hospital, average of 7 days
measure: length of stay in hospital
timeFrame: the day of discharge from hospital, average of 7 days
measure: use of injectable analgesic
timeFrame: Day 7 of the surgery
measure: speed of cicatrization
timeFrame: Day 7 of the discharge from hospital
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
affiliation: Nice University Hospital
name: Claire KOCIALKOWSKI
role: PRINCIPAL_INVESTIGATOR
References: