Effect of Digital Storytelling-Based Animation on Preoperative Anxiety and Physiological Parameters in Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Preoperative Anxiety Measured by the Modified Child Dental Anxiety Scale-Faces (MCDAS-F)
研究概览
简要总结
This randomized controlled trial evaluates the effect of a digital storytelling-based animation on preoperative anxiety and physiological parameters in children aged 5-12 years undergoing dental treatment under general anesthesia. Participants are randomly assigned to either an intervention group, which watches a digital storytelling-based animation before the procedure, or a control group receiving standard preoperative care. Anxiety is assessed using the Modified Child Dental Anxiety Scale-Faces (MCDAS-F) and Facial Image Scale (FIS). Physiological parameters, including heart rate, blood pressure, respiratory rate, and oxygen saturation, are also evaluated. The study aims to determine whether the animation-based intervention reduces preoperative anxiety and physiological stress responses in children.
详细描述
This study is a randomized controlled trial conducted with children aged 5-12 years scheduled to undergo dental treatment under general anesthesia. The study investigates whether a digital storytelling-based animation presented during the preoperative period can reduce children's anxiety and physiological stress responses.
Participants are randomly allocated to an intervention group or a control group. Children in the intervention group watch a digital storytelling-based animation before the procedure, whereas children in the control group receive standard preoperative care without the animation intervention.
Children's anxiety is evaluated using the Modified Child Dental Anxiety Scale-Faces (MCDAS-F) and the Facial Image Scale (FIS) before and after the intervention. Physiological parameters, including heart rate, systolic and diastolic blood pressure, respiratory rate, and oxygen saturation, are assessed at predefined time points during the perioperative period.
The primary objective is to evaluate the effect of the digital storytelling-based animation on preoperative anxiety. The secondary objective is to evaluate its effect on physiological parameters associated with the stress response.
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
- Single (Outcomes Assessor)
盲法说明
The outcome assessor was blinded to group allocation and was not informed whether the participants were assigned to the intervention or control group.
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 5-12 years. Children scheduled to undergo dental treatment under general anesthesia. Children whose parent or legal guardian provided written informed consent.
排除标准
- •Children with a previous experience of general anesthesia. Children with chronic diseases. Children with cognitive, developmental, or communication impairments that could prevent understanding the digital animation or completing the anxiety assessments.
- •Children whose parent or legal guardian did not provide informed consent.
研究组 & 干预措施
Digital Storytelling-Based Animation Group
Children assigned to this group received a digital storytelling-based animation intervention during the preoperative period before general anesthesia. The animation was administered before intravenous access and was designed to familiarize children with the perioperative process and reduce preoperative anxiety. In addition to the animation intervention, children received standard preoperative care.
干预措施: Digital Storytelling-Based Animation (Behavioral)
Control Group
Children assigned to the control group received standard preoperative care without the digital storytelling-based animation intervention.
结局指标
主要结局
Change in Preoperative Anxiety Measured by the Modified Child Dental Anxiety Scale-Faces (MCDAS-F)
时间窗: Immediately before and immediately after the intervention on the day of surgery
Children's preoperative anxiety was assessed using the Modified Child Dental Anxiety Scale-Faces (MCDAS-F). The scale consists of 8 items, each scored from 1 to 5, resulting in a total score ranging from 8 to 40. Higher scores indicate greater dental anxiety. MCDAS-F scores were assessed before and after the digital storytelling-based animation intervention in the experimental group and at corresponding time points in the control group.
次要结局
- Change in Preoperative Anxiety Measured by the Facial Image Scale (FIS)(Immediately before and immediately after the intervention on the day of surgery)
- Change in Heart Rate(Before the intervention, immediately after the intervention, before general anesthesia induction, and 2 hours postoperatively)
- Change in Peripheral Oxygen Saturation (SpO₂)(Before the intervention, immediately after the intervention, before general anesthesia induction, and 2 hours postoperatively)
- Change in Respiratory Rate(Before the intervention, immediately after the intervention, before general anesthesia induction, and 2 hours postoperatively)
- Change in Blood Pressure(Before the intervention, immediately after the intervention, before general anesthesia induction, and 2 hours postoperatively)
研究者
Serpil Boran
Education Nurse
Recep Tayyip Erdogan University