Social Robot Interaction on Fear and Pain Levels in Children
2026年6月7日 更新者：Remziye Semerci、Trakya University
The Effect of Social Robot Interaction on Fear and Pain Levels in Children During Venous Blood Sampling: A Randomized Controlled Study
The goal of this clinical trial is to compare the effectiveness of social robot interaction and digital game-based distraction in reducing fear and pain during venous blood sampling in children aged 4-12 years with chronic diseases.
The main questions it aims to answer are:
- Does social robot interaction reduce procedural fear and pain more effectively than standard care during venous blood sampling?
- Does social robot interaction provide greater emotional recovery after the procedure compared with digital game-based distraction and standard care? Researchers will compare a social robot intervention group, a digital game-based distraction group, and a standard care group to determine their effects on children's fear and pain levels before, during, and after venous blood sampling.
Participants will:
- Be randomly assigned to one of three groups: social robot, digital game, or standard care.
- Complete fear and pain assessments 5 minutes before, during, and 5 minutes after the venous blood sampling procedure.
- Interact with a social robot or play a digital game before and during the procedure if assigned to one of the intervention groups.
- Receive routine clinical care if assigned to the standard care group. The study aims to provide evidence on the effectiveness of technology-based distraction methods for reducing procedural distress and improving the procedural experience of children undergoing venous blood sampling.
研究概览
研究类型
介入性
注册 (实际的)
90
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Istanbul
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Istanbul、Istanbul、土耳其（türkiye）、34010
- Koc University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
是的
描述
Inclusion Criteria:
- Children aged 4-12 years
- Clinical indication for venous blood sampling
- Ability to communicate in Turkish
- No cognitive disabilities
- No sensory disabilities
- Parent or legal guardian provides informed consent
- Child provides verbal assent
Exclusion Criteria:
- Requirement for emergency medical intervention
- Use of analgesic medication within 6 hours prior to the procedure
- Diagnosis of developmental delay
- Previous participation in a social robot-based intervention or study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：控制组
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实验性的：social robot
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Children interacted with an interactive social robot for approximately 5 minutes before venous blood sampling and throughout the procedure.
The robot provided age-appropriate storytelling, songs, verbal communication, movement-based interaction, and visual stimulation to distract children and reduce procedural fear and pain.
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实验性的：digital game
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Children received a digital game-based distraction intervention using the Bubble Rainbow application.
Participants were allowed to familiarize themselves with the game for approximately 5 minutes before venous blood sampling.
During the procedure, children continued playing the game on a tablet device while receiving support from their parents.
The game included interactive activities such as bubble popping, color matching, and visual attention tasks designed to engage the child's attention and reduce procedural fear and pain.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Wong-Baker Faces Pain Rating Scale
大体时间：Pain was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
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Procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale.
The scale consists of six facial expressions scored from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain intensity
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Pain was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
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Children Fear Scale
大体时间：Fear was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
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Procedural fear was assessed using the Scary Scale, a self-report instrument designed for children aged 4-12 years.
The scale consists of six facial expressions scored from 0 (no fear) to 10 (highest fear), with higher scores indicating greater fear levels.
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Fear was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Lakatos G, Gacsi M, Konok V, Bruder I, Bereczky B, Korondi P, Miklosi A. Emotion attribution to a non-humanoid robot in different social situations. PLoS One. 2014 Dec 31;9(12):e114207. doi: 10.1371/journal.pone.0114207. eCollection 2014.
- Fox J, Gambino A. Relationship Development with Humanoid Social Robots: Applying Interpersonal Theories to Human-Robot Interaction. Cyberpsychol Behav Soc Netw. 2021 May;24(5):294-299. doi: 10.1089/cyber.2020.0181. Epub 2021 Jan 11.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年12月21日
初级完成 (实际的)
2025年12月21日
研究完成 (实际的)
2026年4月30日
研究注册日期
首次提交
2026年6月2日
首先提交符合 QC 标准的
2026年6月2日
首次发布 (实际的)
2026年6月8日
研究记录更新
最后更新发布 (实际的)
2026年6月10日
上次提交的符合 QC 标准的更新
2026年6月7日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.