Information and Music Therapy As a Means of Reducing Preoperative Anxiety in Outpatient Surgery. Outpatient Surgery: a Before-and-after Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 198
- 试验地点
- 4
- 主要终点
- Compare the proportion of patients with high anxiety (Visual Analog Score (VAS) for pain greater than or equal to 40/100) in operating waiting room between the two groups (before and after implementation of the actions).
研究概览
简要总结
This is a monocentric, prospective, before-and-after, open-label controlled study, two groups of 99 patients each: "control" group - usual care - versus "intervention" group "Intervention" group - patient information via an explanatory video followed by a 15-minute music therapy session of the patient's choice in the operating waiting room.
详细描述
Although general anaesthesia is used for almost 10 million procedures a year, and the safety of this procedure has improved considerably over the last 25 years, notably with the "safety decree" of December 1994, general anaesthesia remains deeply associated with high levels of preoperative anxiety. Anxiety levels are correlated with two perioperative factors:
- the need for more anesthetic agents to achieve the same level of depth of anesthesia in anxious patients compared to non-anxious/low-anxiety patients
- Development of chronic postoperative pain.
The preoperative consultation and visit by an anaesthetist is an important meeting point to reduce these high levels of anxiety. On the other hand, systematic benzodiazepine-based premedication has been abandoned for some years now, and taking action to reduce the level of anxiety is one of today's challenges, using a variety of means: organizational, video, music, virtual reality, hypnosis...
Unfortunately, the level of publication on the subject remains low.
Currently, a local analysis of this pathway shows several waiting times for which patients are not necessarily informed, and which can generate anxiety during treatment. In addition, our preliminary survey on the subject showed a specific need for information on pain management and anaesthesia recovery. and anesthesia recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient over the age of 18 undergoing scheduled outpatient surgery in the central
- •under general anesthesia. The surgeries surgeries concerned are versatile: Digestive (inguinal hernias, proctology, cholecystectomy, etc.), thoracic endoscopy (biopsy examination under GA), gynecological (hysteroscopy, diagnostic laparoscopy diagnostic laparoscopy, cerclage...), ENT (endoscopies, septoplasty, meatotomy...), Urology (JJ catheter insertionTOT/TVT, botulinum toxin injection...), vascular (stripping)
- •Patient with oral non-opposition prior to any study procedure
- •Not to have objected to inclusion in the research
- •Patient affiliated to a health insurance scheme
排除标准
- •Patients undergoing emergency surgery, considered full stomach
- •Patient not respecting the central block route (interventional radiology in this case)
- •First patients in the program because they present the risk of less than than 15 minutes
- •Patients who do not understand French
- •Patient deprived of liberty or under guardianship
- •Pregnant or breast-feeding women
结局指标
主要结局
Compare the proportion of patients with high anxiety (Visual Analog Score (VAS) for pain greater than or equal to 40/100) in operating waiting room between the two groups (before and after implementation of the actions).
时间窗: up to 24 hours
The primary endpoint was the presence or absence of high anxiety in operating waiting room (T2), measured by an VAS score \> 40/100. A range of scores from 0-100. A higher score indicates greater pain intensity.
次要结局
- Compare anxiety levels in preoperative reception unit (T1) and in post anesthesia care unit room (T3) between the two groups: Amsterdam Preoperative Anxiety and Information Scale (APAIS) and VAS score(up to 24 hours)
- Compare the time to loss of consciousness measured in the operating room between both groups(up to 24 hours)
- Compare anxiety levels in operating waiting room (T2)(up to 24 hours)
- Compare the amount of propofol (mg/kg) at induction required to achieve loss of consciousness between the two groups.(up to 24 hours)
- Evaluate the level of satisfaction of each action implemented using a specific questionnaire at the end of the program.(up to 24 hours)
- Evaluate the proportion of dropouts for each action, i.e. the proportion of patients who did not viewed the video until the end, or did not complete the entire music therapy session.(up to 24 hours)