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

Not Applicable

Completed

• Conditions: Gynecological Disease
• Interventions: Other: Hypnosis; Other: pre-surgery consultation

• Registration Number: NCT05276882
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-11
• Study Start: 2022-12-08
• Primary Completion: 2024-07-19
• Study Completion: 2024-07-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hypnosis	Hypnosis	-
pre-surgery consultation	pre-surgery consultation	-

Primary Outcome Measures

Name	Time	Method
Patient anxiety	Up to 2 months	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

Secondary Outcome Measures

Name	Time	Method
length of stay in hospital	the day of discharge from hospital, average of 7 days	length of stay in hospital defined as the number of days between the day of surgery and discharge
speed of cicatrization	Day 7 of the discharge from hospital	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.
Patient satisfaction	day of discharge from hospital, average of 7 days	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
use of injectable analgesic	Day 7 of the surgery	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.

Trial Locations

Locations (1)

Nice University Hospital; 🇫🇷 Nice, France