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临床试验/NCT07769385
NCT07769385Enrolling By Invitation不适用

The Effects of Robotic Fish and Aquarium Fish Interventions on Fear, Pain, and Anxiety in Children During Painful Procedures

Inonu University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年6月14日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
120
试验地点
1
主要终点
Pain Level Assessed Using the Wong-Baker FACES Pain Rating Scale

研究概览

简要总结

This study aims to find out whether robotic fish and aquarium fish can help reduce pain, fear, and anxiety in children during painful medical procedures.

The main questions this study aims to answer are:

Does watching robotic fish during a painful procedure reduce children's pain, fear, and anxiety? Does watching aquarium fish during a painful procedure reduce children's pain, fear, and anxiety? Are there differences in pain, fear, and anxiety between children receiving these interventions? During the painful procedure, children in the intervention groups will watch either robotic fish or aquarium fish as a distraction. Children's pain, fear, and anxiety levels will be assessed using age-appropriate measurement tools. Researchers will compare the results between the study groups to determine whether robotic fish or aquarium fish can help children feel more comfortable during painful medical procedures.

The findings may provide information about simple, non-drug methods that nurses and other health care providers can use to help reduce children's negative experiences during painful procedures.

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 (Participant)

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Being between the ages of 5 and 10, and
  • Being subjected to painful procedures.

排除标准

  • The child has a physical disability, and
  • There are circumstances that prevent the child's facial expressions from being clearly visible.

结局指标

主要结局

Pain Level Assessed Using the Wong-Baker FACES Pain Rating Scale

时间窗: Immediately after completion of the painful procedure

Children's pain intensity during the painful procedure will be assessed using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 to 10, with higher scores indicating greater pain intensity.

Fear Level Assessed Using the Children's Fear Scale

时间窗: Immediately before the intervention and immediately after completion of the painful procedure

Children's procedure-related fear will be assessed using the Children's Fear Scale (CFS). The scale consists of five facial expressions representing increasing levels of fear and is scored from 0 to 4. A score of 0 indicates no fear and a score of 4 indicates extreme fear. Higher scores indicate greater fear.

Anxiety Level Assessed Using the Children's Anxiety Meter-State

时间窗: Immediately before the intervention and immediately after completion of the painful procedure

Children's state anxiety related to the painful procedure will be assessed using the Children's Anxiety Meter-State (CAM-S). The scale is scored from 0 to 10, with higher scores indicating greater state anxiety.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdullah Sarman

Associate Professor

Inonu University

研究点 (1)

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