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临床试验/NCT07414628
NCT07414628尚未招募不适用

The Effect of a Drama-Based Coloring Storybook on Children's Fear, Anxiety, and Pain Management in the Perioperative Process: "Alican's Brave Journey"

Bingol University0 个研究点目标入组 72 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
72
主要终点
Preoperative Anxiety Level in Children

研究概览

简要总结

This randomized controlled study aims to evaluate the effect of a drama-based coloring storybook on children's fear, anxiety, and pain management during the perioperative process. The study will be conducted with children aged 6-9 years who are scheduled for elective surgery. Participants will be randomly assigned to either an intervention group receiving the drama-based coloring storybook or a control group receiving routine preoperative care. Levels of fear, anxiety, and pain will be assessed using validated measurement tools at predefined perioperative time points. The findings are expected to contribute to evidence-based, child-centered perioperative care practices.

详细描述

This study is a randomized controlled trial designed to examine the effectiveness of a drama-based coloring storybook intervention in reducing fear and anxiety and improving pain management in children during the perioperative process. The study population consists of children aged 6-9 years undergoing elective surgical procedures. Participants will be randomly allocated to either an intervention group or a control group.

Children in the intervention group will receive a drama-based coloring storybook titled "Alican's Brave Journey", which introduces the perioperative process through age-appropriate language, illustrations, and interactive coloring activities. The storybook will be administered in the preoperative period by the researcher. The control group will receive routine preoperative care provided by the hospital. Children's fear, anxiety, and pain levels will be measured using validated assessment tools at preoperative and postoperative stages. The study aims to provide evidence on the effectiveness of drama-based educational materials in pediatric perioperative care.

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
Single (Participant)

盲法说明

Participants were blinded to group allocation in order to reduce expectation bias. Due to the nature of the intervention, the care provider and the investigator were aware of the assigned groups. Outcome assessments were conducted using standardized self-report scales completed by the participants.

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Children aged 6-9 years.
  • Children scheduled for surgery due to circumcision.
  • Children who have not undergone previous surgery.
  • Children without vision, hearing, or speech problems.

排除标准

  • Children who have undergone previous surgery.
  • Children with vision, hearing, or speech problems.

研究组 & 干预措施

Drama-Based Coloring Storybook Group

Experimental

Participants in this group receive a drama-based coloring storybook before surgery. The storybook is designed to prepare children for the perioperative process and to reduce fear, anxiety, and perceived pain through age-appropriate narratives and coloring activities.

干预措施: Drama-Based Coloring Storybook Intervention (Behavioral)

Control Group (Routine Care)

No Intervention

Participants in this group receive routine preoperative care according to hospital protocols, without exposure to the drama-based coloring storybook.

结局指标

主要结局

Preoperative Anxiety Level in Children

时间窗: One hour before surgery and 10 minutes before surgery (prior to anesthesia induction)

Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale - Short Form (mYPAS-SF), a validated observational scale consisting of 22 items across five domains: activity, speech, emotional expressivity, state of arousal, and interaction with family members. Total scores range from 23.33 to 100, with higher scores indicating greater anxiety.

Fear Level in Children

时间窗: One hour before surgery, 10 minutes before surgery (prior to anesthesia induction), and one hour after surgery

Fear levels will be assessed using the Children's Fear Scale (CFS), a validated self-report scale for children. The scale consists of five facial expressions scored from 0 to 4, with higher scores indicating greater fear.

Postoperative Pain Level in Children

时间窗: One hour after surgery

Postoperative pain will be assessed using the Wong-Baker FACES Pain Rating Scale, a validated self-report pain scale for children. The scale ranges from 0 to 5, where 0 indicates no pain and 5 indicates the worst pain. Higher scores indicate greater pain intensity

次要结局

未报告次要终点

研究者

发起方
Bingol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yusuf Budak

Research Assistant, Department of Nursing

Bingol University

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