Improving the Quality of Anesthesia Induction by Reducing Preoperative Anxiety in the Operating Room
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Children's perioperative anxiety levels at the time of anesthetic induction as assessed by the mYPAS
研究概览
简要总结
Preoperative anxiety refers to a range of physical and/or psychological manifestations, which can have a significant impact on medical outcomes and the experience of the child and their parents. This study aims to evaluate the impact of preoperative preparation combined with a hypnosis session conducted by nurse anesthetists (IADE) trained in working with children and their families. The goal is to improve the child's experience and reduce perioperative anxiety and stress.
It is divided into two phases:
- First phase, called "Before": Standard preoperative care is provided according to the existing protocol in the department. Anxiety levels will be measured at the time of induction in the operating room.
- Second phase, called "After": In the two weeks prior to surgery, in addition to the standard preoperative care currently in place, the patient will receive a 30-minute visit from a nurse anesthetist trained in hypnosis. This is an added procedure complementing the anesthesia consultation. The visit is divided into two parts: 10 minutes to review and clarify the explanations given by the anesthesiologist and surgeon, and 20 minutes of a formal hypnosis session. A personalized liaison form will be completed to facilitate communication between the consultation and the operating room. Anxiety levels will again be measured at the time of induction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 5 and 12 years, i.e., able to engage in verbal communication;
- •Scheduled for surgery requiring hospitalization at least one day prior to the procedure, including but not limited to gastrointestinal or urological surgery, ENT procedures, plastic interventions, and orthopedic surgery (e.g., scoliosis correction);
- •Provision of written informed consent by the parents or legal guardians (or by the sole parent/legal guardian, where applicable);
- •Parental agreement to participate in the study by completing the required questionnaires;Affiliation with or entitlement to a national social security scheme
排除标准
- •Patients with cognitive developmental disorders;
- •Patients requiring regular general anesthesia as part of ongoing medical management;
- •Patients undergoing emergency surgery;
- •Patients with a known psychiatric disorder;
- •Patients diagnosed with an autism spectrum disorder (ASD).
研究组 & 干预措施
Part 2: Standard preoperative care before anesthesia induction
Part 2: Children aged between 5 and 12 years scheduled for surgery requiring hospitalization, recieving standard preoperative care prior to anesthesia induction. Anxiety levels will be measured at the time of induction in the operating room.
Parti 1: Preoperative care combined with a hypnosis session
Part 1: Children aged between 5 and 12 scheduled for surgery requiring hospitalization, recieving a 20 min hypnosis session within two weeks prior to anesthesia induction in addition to standard preoperative care. Anxiety levels will be measured at the time of induction in the operating room.
干预措施: Hypnosis session (Behavioral)
结局指标
主要结局
Children's perioperative anxiety levels at the time of anesthetic induction as assessed by the mYPAS
时间窗: Day 1 ( Anesthesia induction and surgery)
Mesure of the Modified Yale Preoperative Anxiety Scale by anesthetics or surgical nurse. The total score ranges from 23 to 100: children are considered moderately anxious for a score above 24, and highly anxious for a score above 30.
次要结局
- Children's compliance during induction as assessed by the Induction Compliance Checklist(Day 1 (Anesthesia induction))
- Time spent in the PACU(Day 1 ( From arrival in the PACU until return to the hospital room))
- Postoperative delirium as assessed by the PAED Scale(Day 1 (After surgery))
- Postoperative pain as assessed by the PPMP scale(Day 2 and 5 after sugery)
- Postoperative pain as assessed by the VAS scale(Day 1 (After surgery))
- Postoperative pain as assessed by the FLACC scale.(Day 1 (After surgery))
- Behavioral assessment(Day 1, 2 and 5 after sugery)
- Parental satisfaction(At the day of patiet sicharge or Day 14 postoperatevly)