Bookbased Emotion and Anxiety Reduction: A Children's Storybook Intervention to Reduce Preoperative Fear, a Single-center Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- modified Yale Preoperative Anxiety Scale
研究概览
简要总结
Many children are afraid of surgery and anesthesia. Studies show that up to 60% of children experience significant anxiety before a scheduled procedure. This fear is caused, for example, by the unfamiliar hospital environment, separation from parents, worry about pain, or because they do not know exactly what will happen. Severe anxiety before surgery can complicate the procedure and is linked to higher stress, increased post-operative pain perception, and behavioral changes. This study investigates whether a specially developed, age-appropriate children's book can help reduce anxiety before surgery. The book explains the anesthesia and surgical procedure in a child-friendly way using pictures and simple text. Children aged 4 to 10 who are undergoing surgery at the Inselspital Bern for an inguinal, umbilical, or ventral hernia can participate. A total of 50 children are to be included. The children will be randomly divided into two groups: One group receives the children's book to prepare at home. The other group receives the usual preparation without the book. The children's anxiety is measured using an established observation scale - once during the preliminary examination and again on the day of surgery before anesthesia. In addition, several contributing factors are recorded, such as how well the child cooperates during the induction of anesthesia or how much anesthetic medication is required. Parents will complete a short questionnaire regarding their own anxiety. Participation involves minimal risk. Only a children's book is provided, and the children's behavior is observed. No additional medical interventions are planned. The aim of the study is to test whether a simple, cost-effective, and easily implementable tool - a children's book - can effectively reduce anxiety before surgery. If the book proves to be helpful, it could be routinely used to prepare children for surgery in the future.
详细描述
Background and Rationale:
Many children experience significant anxiety before scheduled surgical procedures. Literature indicates that up to 60% of pediatric patients exhibit substantial preoperative anxiety. This fear is primarily driven by an unfamiliar hospital environment, separation from parents, anticipation of pain, and a lack of understanding regarding the upcoming procedures. High levels of preoperative anxiety can complicate the clinical workflow, increase patient stress, elevate post-operative pain perception, and lead to negative postoperative behavioral changes. This study investigates whether a specially designed, age-appropriate children's book can effectively reduce preoperative anxiety. The educational book utilizes pictures and simplified language to explain the processes of anesthesia and surgery in a child-friendly manner.
Study Design and Objectives: This is a randomized controlled trial aiming to evaluate the efficacy of an educational children's book as a low-threshold intervention to mitigate preoperative anxiety in pediatric patients. The primary objective is to assess whether introducing this book during home preparation significantly decreases anxiety scores compared to standard care.
Participant Enrollment and Randomization: The study aims to enroll a total of 50 pediatric patients. Eligible participants are children aged 4 to 10 years scheduled for elective surgery (inguinal, umbilical, or ventral hernia repair) at the Inselspital Bern. Upon enrollment, participants will be randomly allocated into one of two parallel groups:
Intervention Group: Participants receive the specialized children's book for preoperative preparation at home.
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
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4 to 10 years at the time of surgery
- •Scheduled for elective surgical intervention (inguinal hernia, umbilical hernia, epigastric or supraumbilical hernia)
- •Understanding of the German language
- •Written informed consent obtained from at least one parent or legal guardian
排除标准
- •Emergency surgical procedures
- •History of previous surgery
- •Less than 7 days between randomization and surgical procedure
- •Known developmental delay, cognitive impairment, or psychiatric disorder that may interfere with anxiety assessment
研究组 & 干预措施
Reading the book
Children receive a book preoperatively that they read together with their parents
干预措施: Reading a childrens book to prepare for the surgery (Other)
Standard care
Children do not receive the book preoperatively
干预措施: Standard Care (in control arm) (Other)
结局指标
主要结局
modified Yale Preoperative Anxiety Scale
时间窗: perioperative
Preoperative anxiety level on the day of surgery, measured using the modified Yale Preoperative Anxiety Scale (mYPAS), assessed prior to induction of anesthesia before administration of any sedative premedication. The mYPAS Scale ranges from 23,33 (minimum) to 100 (maximum), with higher scores indicating greater preoperative anxiety. The scale comprises 22 items across 5 behavioral categories (activity, vocalization, emotional expressivity, state of apparent arousal, use of parents).
次要结局
- Baseline modified Yale Preoperative Anxiety Scale(Baseline)
- Anesthetic medication(perioperative)
- Demographics(Baseline)
- Postoperative delirium(perioperative)
- Parental anxiety(Baseline)
- Child compliance during induction (Induction Compliance Checklist)(perioperative)
- Parental educational level and age(Baseline)
- Acceptability of the book intervention using a questionnaire(postoperative)