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临床试验/NCT07549191
NCT07549191已完成不适用

The Effect of a Child's Interaction With a Social Robot During Dressing on Fear and Pain

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Children's Fear during wound care

研究概览

简要总结

The aim of this randomized controlled trial, consisting of 30 experimental and 30 control groups, was to examine the effect of a child's interaction with a social robot during wound dressing on their fear and pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Triple (Participant, Care Provider, Investigator)

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

  • The children should be between 5 and 10 years old.
  • The child must have come to the emergency room for initial wound dressing.
  • The child and parent must be able to speak and understand Turkish.
  • The children must not have received any analgesics in the last four hours.

排除标准

  • The child does not apply for their first dressing change,
  • The child is not between 5-10 years old,
  • The child has a mental, visual, or hearing impairment,
  • The child has received any analgesic within the last four hours,
  • An analgesic-containing ointment has been applied before the dressing change.

研究组 & 干预措施

Not robot

No Intervention

The control group consists of 30 child patients aged 5-10 years.

Robot

Experimental

The intervention group consists of 30 child patients aged 5-10 years.

干预措施: Social Robot (Device)

结局指标

主要结局

Children's Fear during wound care

时间窗: 3 months

In the intervention group, the child interacts with the social robot during wound dressing, and fear scales are completed by the child, parent, and researcher before and after the procedure. ''The Child Fear Scale'' is designed for children aged 5-10 years. This scale uses a 0-4 rating system, representing five different facial expressions ranging from a blank expression (0=no anxiety) to a frightened face (4=severe anxiety). 0 indicates no anxiety, 1 mild anxiety, 2 moderate anxiety, 3 anxiety, and 4 severe anxiety.

Children's Pain during wound care

时间窗: 3 months

In the intervention group, the child interacts with a social robot during wound dressing, and pain scales are completed by the child, parent, and researcher before and after the procedure. ''The WongBaker Facial Pain Scale'' is used for children aged 3 to 18 years. It consists of six different facial expressions, starting with a smiling face and ending with a crying face. The pain level corresponding to the faces on the scale is explained to the child: "Face 0" indicates no pain and is very happy. "Face 2" has some pain. "Face 4" has some more pain. "Face 6" has more pain. "Face 8" has very much pain. "Face 10" has unbearable pain.

次要结局

未报告次要终点

研究者

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

Cihan KAZEL

Master Degree Student

Ondokuz Mayıs University

研究点 (1)

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