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临床试验/NCT05752708
NCT05752708招募中不适用

Evaluation of Perioperative Anxiety Risk Factors in Parents of Children Undergoing Thoracic Surgery

National Institute for Tuberculosis and Lung Diseases, Poland1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2023年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
123
试验地点
1
主要终点
Parents' anxiety and information requirement in the preoperative phase

研究概览

简要总结

Risk factors associated with perioperative anxiety in parents of pediatric patients undergoing thoracic surgery are unknown. It is therefore necessary to identify them in order to better understand, above all, modifiable factors. This will allow the implementation of psychological interventions tailored to the individual needs of parents to strengthen their coping mechanisms before surgery, and thus facilitate the recovery process of their children after surgery.

The purpose of the study is:

  1. assessment of the level of anxiety experienced by parents before and after thoracic surgery,
  2. assessment of risk factors for parents' perioperative anxiety,
  3. assessment of the relationship between parents' perioperative anxiety and satisfaction with postoperative analgesia

详细描述

According to the literature, parents of children undergoing various types of surgical procedures are accompanied by high levels of anxiety. It was found that the level of anxiety is higher in female parents and is related to the child's age, fear of postoperative pain in children, the scope of information about the course of surgery and anesthesia, and potential complications that may occur during and after the child's operation. Parental anxiety correlates positively with child anxiety. High levels of anxiety in children can lead to many undesirable clinical, psychological and behavioral symptoms during hospitalization (delirium, increased postoperative pain, greater need for analgesia) and after discharge from the hospital (separation anxiety, sleep disorders, aggression, enuresis).

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • parent of child <18 years
  • parent of child undergoing thoracic surgery
  • parent of child with intravenous or epidural postoperative analgesia
  • parent of child with 1-3 score according to the American Society of Anesthesiologists

排除标准

  • a parent of a nationality other than Polish
  • difficult communication with parent
  • parent of a child undergoing oncological treatment
  • parent of a child without chest drainage
  • lack of parental consent.

结局指标

主要结局

Parents' anxiety and information requirement in the preoperative phase

时间窗: before surgery

The Amsterdam Preoperative Anxiety and Information Scale (APAIS) consists of six items. The items are rated on a five point Likert scale with the end poles "not at all" (1) and "extremely" (5). It represents the two scales anxiety (Item 1, 2, 4 and 5) and need-for-information (Items 3 and 6). A total value is calculated by adding up the two scales anxiety and need-for-information. A higher score means higher preoperative anxiety and a greater need for information.

Parents' anxiety state

时间窗: before surgery, before discharge from the hospital

Anxiety was determined with a Polish version of the State-Trait Anxiety Inventory (STAI; range: 20-80 pts). The instrument consisting of two separate 20-item scales measuring state and trait anxiety. The results will be expressed as sten scores, from 1-10 (1-4 = low level of anxiety, 5-6 = moderate level of anxiety, \>7 = high level of anxiety).

次要结局

  • Parents' satisfaction(up to discharge from the hospital)
  • Socio-demographic factors(perioperative period)

研究者

发起方
National Institute for Tuberculosis and Lung Diseases, Poland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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