The Effect of Two Different Distraction Methods Applied Before Day Case Surgery on Children's Fear and Emotional Indicators: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Child Fear Scale (CFS) Score
研究概览
简要总结
Summary The aim of this study is to see if storybooks or hand puppets help reduce fear in children before outpatient surgery. Researchers want to find out which of these two methods works better to help children feel calmer and less upset.
Why is this study being conducted? Going into surgery can be frightening for children. This research is looking for simple and fun ways to reduce a child's fear without using medication.
How will the research be conducted?
The study included 99 children (ages 4-7) undergoing outpatient surgery. The children were divided into three equal groups:
Group 1 (Control): Received standard hospital care.
Group 2 (Storybook): Read an educational book about a character going into surgery.
Group 3 (Puppet): Played with a hand puppet before the procedure.
Researchers measured the children's fear and emotional responses twice: approximately 1 hour before surgery and immediately before entering the operating room. By comparing these scores, the study shows whether it was the storybook or the puppet that helped the children feel better.
详细描述
The aim of this randomized controlled trial is to evaluate and compare the effectiveness of two different non-pharmacological distraction methods-educational storybooks and hand puppets-on preoperative fear and emotional manifestations in children undergoing day case surgery.
Methodology:
The study was conducted with 99 children, aged 4 to 7, who met the inclusion criteria. Participants were randomly assigned to one of three groups using a 1:1:1 allocation ratio:
Control Group (n=33): Received standard preoperative nursing care, including routine information provided by the hospital staff.
Storybook Group (n=33): In addition to standard care, children were read an educational storybook titled "Elif Ameliyat Oluyor" (Elif is Having Surgery). The book describes the surgical process through a child's perspective to familiarize them with the environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
Surgical procedures were scheduled for wednesdays and fridays. Therefore, the research was conducted on wednesdays and fridays. Wednesday was puppet day and Thursday was storybook day. Consequently, "Due to the nature of the interventions (storybooks=33 and hand puppets=33), participants were completely blinded to the assigned group. However, the research practitioner was dominant in the process, and the nurse was blinded to the study's baseline hypotheses. Furthermore, during the statistical evaluation phase, the other researcher was blinded to group assignments to prevent bias and was not involved in the data collection process." After the experimental groups reached the desired number, control groups =33 were collected.
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged between 4 and 7 years.
- •Children hospitalized in the pediatric surgery ward.
- •Scheduled for elective (planned) surgery.
- •Ability to understand and speak Turkish.
- •Willingness of both the child and a parent/legal guardian to participate in the study.
排除标准
- •Children with long-term hospitalization history.
- •Participants who received analgesic or sedative medication within the last 24 hours.
- •Presence of major trauma, chronic disease, or chronic pain conditions requiring rapid assessment.
- •Any physical or cognitive impairment that hinders effective communication (e.g., significant visual, hearing, or speech impairments).
- •Presence of diagnosed mental or developmental disabilities.
- •History of psychiatric disorders such as Attention Deficit Hyperactivity Disorder (ADHD).
- •Participants or parents who wish to withdraw from the study at any stage.
研究组 & 干预措施
Storybook Group
Prior to the intervention, participants were read an educational storybook titled "Elif is Having Surgery" by a researcher. The intervention focused on introducing the child to the surgical process through storytelling.
干预措施: Storybook Group (Behavioral)
Hand Puppet Group
Participants engaged in pre-intervention interactive play with a hand puppet under the guidance of a researcher. The puppet recorded the treatment process to simulate the treatment and provide emotional support through play.
干预措施: Hand Puppet Group (Behavioral)
Control Group
Participants in this group received only the standard preoperative nursing care provided by the hospital, with no additional distraction methods.
干预措施: Control Group (Other)
结局指标
主要结局
Child Fear Scale (CFS) Score
时间窗: "Baseline (immediately upon hospital admission, approximately 1 hour before surgery) and pre-operative phase (approximately 60 minutes after the first measurement, just before transfer to the operating room)."
The CFS is a self-report scale consisting of five faces ranging from a neutral expression (0 - no fear) to a frightened expression (4 - extreme fear). It is used to measure the child's subjective level of fear.
Children's Emotional Manifestation Scale (CEMS) Score
时间窗: Baseline (immediately upon hospital admission, approximately 1 hour before surgery) and pre-operative phase (approximately 60 minutes after the first measurement, just before transfer to the operating room).
An observational scale consisting of 5 categories (facial expression, vocalization, activity, interaction, and cooperation). Each category is scored from 1 to 5, with total scores ranging from 5 to 25. Higher scores indicate higher emotional distress.
次要结局
未报告次要终点
研究者
Emine Beyaz
Principal Investigator
Muş Alparslan University