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

NCT ID: NCT05276882

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-08

Study Completion Date

2024-07-19

Brief Summary

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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.

Detailed Description

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Conditions

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Gynecological Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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hypnosis

Group Type EXPERIMENTAL

Hypnosis

Intervention Type OTHER

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 consultation

Group Type ACTIVE_COMPARATOR

pre-surgery consultation

Intervention Type OTHER

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)

Interventions

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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.

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire KOCIALKOWSKI

Role: PRINCIPAL_INVESTIGATOR

Nice University Hospital

Locations

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Nice University Hospital

Nice, , France

Site Status

Countries

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France

Other Identifiers

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21-AOI-08

Identifier Type: -

Identifier Source: org_study_id

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