Evaluation of the Effectiveness of Hypnosis Support on Patient Perception of Outpatient Surgery Under Local Anaesthesia in the Maxillo-Facial Surgery Department of the CHU Amiens-Picardie.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- variation in Spielberger's anxiety self-assessment questionnaire score between the patient's arrival in the operating room and his departure
研究概览
简要总结
Many clinical trials assessing the effectiveness of hypnosis have been conducted in recent years, some of which show that hypnosis reduces pain perception better than drug treatments administered to control groups, and that it is at least as effective as other complementary therapies (such as massage, acupuncture, yoga). However, their conclusions are limited by a significant risk of bias, and further studies with rigorous methodology remain necessary. The hypothesis of this study is that hypnosis support methods can reduce anxiety in patients requiring facial surgery under local anaesthesia, and thus improve their medical management.
The purpose of this study is to evaluate the effectiveness of hypnosis support on the patient's state of anxiety before and after outpatient surgery under local anaesthesia in the Maxillofacial Surgery Department.
详细描述
Interventions performed under local anaesthesia may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. In order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines. Hypnosis in particular has long been used in the non-pharmacological management of pain and anxiety.
Many clinical trials assessing the effectiveness of hypnosis have been conducted in recent years, some of which show that hypnosis reduces pain perception better than drug treatments administered to control groups, and that it is at least as effective as other complementary therapies (such as massage, acupuncture, yoga). However, their conclusions are limited by a significant risk of bias, and further studies with rigorous methodology remain necessary. The hypothesis of this study is that hypnosis support methods can reduce anxiety in patients requiring facial surgery under local anaesthesia, and thus improve their medical management.
Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will be informed of the study in consultation by the maxillofacial surgeon. If they give their informed consent, a State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire") will be given to them and collected on the same day. Each patient's anxiety score will be calculated so as to select only patients who are at least lightly anxious about their management (score ≥ 36). The latter will be randomized into 2 groups, one benefiting from experimental management based on hypnosis techniques and the other benefiting from conventional management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient treated under local anaesthesia in the Maxillo Facial Surgery department with ultra-short circuit
- •Patient undergoing face surgery
- •Patient who has received appropriate information and has provided informed consent
- •Adult patient ≥ 18 years old
- •Patient with a score of ≥ 36 on the initial anxiety self-assessment questionnaire
排除标准
- •Patient under general anaesthesia
- •Patients treated in conventional inpatient care or in the traditional ambulatory circuit
- •Patient under guardianship or trusteeship
- •Minor patient < 18 years of age
- •Patient who has not provided informed consent or who cannot submit to the study protocol
- •Patient suffering from cognitive disorders (ex: Alzheimer's disease)
- •Patients who are deaf or hearing-impaired
研究组 & 干预措施
Hypnosis
Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on hypnosis techniques.
干预措施: State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire") (Other)
Hypnosis
Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on hypnosis techniques.
干预措施: hypnosis techniques (Procedure)
conventional management
Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from conventional management (local anaesthesia).
干预措施: State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire") (Other)
conventional management
Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from conventional management (local anaesthesia).
干预措施: local anaesthesia (Procedure)
结局指标
主要结局
variation in Spielberger's anxiety self-assessment questionnaire score between the patient's arrival in the operating room and his departure
时间窗: on the day of surgery under local anaesthesia.
The State-Trait Anxiety Inventory (STAI) (or Spielbergers's anxiety self-assessment questionnaire) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety.
次要结局
- measure of operating time(on the day of surgery under local anaesthesia.)
- Variation of amount of local anaesthetic(on the day of surgery under local anaesthesia.)
- Value reported by the patient on the Visual Analogue Pain Scale after surgery(on the day of surgery under local anaesthesia.)