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

NCT05276882 | Completed

• 1 other identifier: 21-AOI-08
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecological Disease

Keywords

laparoscopic gynecological surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient satisfaction

  day of discharge from hospital, average of 7 days

• length of stay in hospital

  the day of discharge from hospital, average of 7 days

• use of injectable analgesic

  Day 7 of the surgery

• speed of cicatrization

  Day 7 of the discharge from hospital

Study Arms (2)

hypnosis

EXPERIMENTAL

Other: Hypnosis

pre-surgery consultation

ACTIVE COMPARATOR

Other: pre-surgery consultation

Interventions

Hypnosis 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.

hypnosis

pre-surgery consultation 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)

pre-surgery consultation

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice University Hospital

Nice, France

Location

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Claire KOCIALKOWSKI

  Nice University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 11, 2022
• Study Start: December 8, 2022
• Primary Completion: July 19, 2024
• Study Completion: July 19, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)