The Effect of Explaining the Perioperative Process with Our Drawings on Anxiety in Pediatric Patients; Prosperative Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Modified Yale Preoperative Anxiety Scale
研究概览
简要总结
Preoperative anxiety is characterized by subjective emotions such as irritability, irritability, sadness, and unhappiness. Studies have shown that preoperative anxiety negatively affects children both psychologically and physiologically. Preoperative anxiety occurs in 60-80% of children undergoing anesthesia and surgery and is associated with undesirable consequences such as nightmares, separation anxiety, eating disorders, negative behavioral changes such as increased fear of doctors, increased need for analgesics. The aim of this study is to evaluate the preoperative and pre-sedation anxiety levels in pediatric patients by explaining the peroperative process to the patients with drawings.
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
- Triple (Participant, Care Provider, Investigator)
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
- •ASA I patients without any comorbidities who were operated on by the ENT,
- •Patients between the ages of 5-12,
- •And patients who could be contacted and did not have any anxiety problems were included.
排除标准
- •Patients with liver and/or kidney failure, trauma patients, ASAII-III-IV patients, patients with bleeding disorders,
- •those using medications that would affect the coagulation system, patients with local anesthetic allergy, patients with immobility and malnutrition, .And patients who did not want to participate in the study were excluded from the study.
结局指标
主要结局
Modified Yale Preoperative Anxiety Scale
时间窗: surgical ward (T0), in the preoperative waiting area (T1), at the time of separation from the parent to the operating room (T2), upon entry to the operating room (T3), and at the time of starting intravenous induction (T4).
Activity Interested in his/her surroundings, curious, playing with toys, reading (or other age-appropriate activities); may wander around the waiting room or operating room or go to the parent to retrieve a toy; Can gravitate towards operating room equipment 1 He is indifferent to his surroundings, does not play, looks at the ground, plays with his hands and fingers, sucks his thumb; may sit very close to the parent while waiting. 2 Aimless movements directed from the toy towards the parent in an unfocused manner; crazy/exaggerated movements or tricks; writhing, moving on the couch; may push the mask or hug the parent during induction. 3 The person who actively tries to move away, pushing with his feet and arms, can use his whole body to move away; may not be able to separate from the parent who is running around in the waiting room without focusing, not paying attention to toys, or clinging desperately.4 Speech Reading (may not speak in relation to the activity), asking
次要结局
- heart rate(when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation)
- Riker agitation scala(after extubation)
- Visual analog scala(surgical ward (T0), in the preoperative waiting area (T1), at the time of separation from their child)
- mean arterial pressure(when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after)
研究者
Hülya Tosun Söner
Anesthesiology and Reanimation Spesialist
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital