Improved Rehabilitation After Surgery and Hypnosis: Benefits Potentiated by a Preoperative Consultation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Patient anxiety
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Patient anxiety
时间窗: 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
次要结局
- length of stay in hospital(the day of discharge from hospital, average of 7 days)
- speed of cicatrization(Day 7 of the discharge from hospital)
- Patient satisfaction(day of discharge from hospital, average of 7 days)
- use of injectable analgesic(Day 7 of the surgery)