跳至主要内容
临床试验/NCT07009028
NCT07009028招募中不适用

The Effect of Storigami Method on Pain, Fear and Anxiety Levels Associated With Peripheral Intravenous Catheterisation in Children

Ege University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Reducing the child's fear

研究概览

简要总结

The aim of this study was to determine the effect of storigami method on reducing pain, fear and anxiety of children in peripheral intravenous catheter applications in children aged 6-9 years who were hospitalized in the pediatric health and diseases clinic.

详细描述

He stated that children and their families who frequently visit hospitals for follow-up, treatment or various anomalies have negative hospital experiences due to fear, anxiety and painful procedures, and that these negative experiences may cause phobias and avoidance of medical procedures in children in the future. Therefore, this study was planned to determine the effect of storigami method on reducing pain, fear and anxiety of children in peripheral intravenous catheter applications in children aged 6-9 years who were hospitalized in the pediatric health and diseases clinic. Storigami is a method that involves the use of origami and stories at the same time and can be used to reduce pain in hospitals. The method, which is planned to be used to minimize negative hospital experiences, is thought to be a promising, cost-effective and safe non-pharmacological technique that can be used safely to reduce fear, anxiety and pain of hospitalized patients.

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
None

入排标准

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

入选标准

  • •Volunteering to participate in the study
  • •The child is between 6-9 years old
  • •First time peripheral intravenous catheter insertion since admission to the clinic
  • •The child has no vision, hearing and speech problems
  • •The child has no mental retardation
  • •Know/speak Turkish
  • •No complaints such as pain, nausea and vomiting that may affect fear and anxiety
  • •No sedative or analgesic was given to the child immediately before the peripheral intravenous catheterization procedure

排除标准

  • •The child has a chronic, congenital, metabolic or neurodegenerative disease
  • •Failed attempt at peripheral intravenous catheterization,
  • •Failure to complete or incomplete completion of questionnaires,
  • •A different invasive intervention was performed immediately before PIC application,
  • •The child does not comply during the procedure,
  • •The child wants to leave the study

研究组 & 干预措施

Arms

No Intervention

No Intervention: children will receive standard care during peripheral intravenous catheterization.

Arm

Experimental

Experimental:storigami method will be applied during peripheral intravenous catheterization of children

干预措施: Storigami figure (Combination Product)

结局指标

主要结局

Reducing the child's fear

时间窗: during peripheral intravenous procedure

The Children's Fear Scale (CFS) was graded on a scale of 0-4 and included five display images with facial expressions ranging from neutral (0 = no anxiety) to fearful (4 = severe anxiety). Children between the ages of 5 and 10 can use it before and after treatments. For child and proxy reports, it contain different instructions to reduce the child's fear during the peripheral intravenous catheterization procedure.

Reducing the child's anxiety

时间窗: during peripheral intravenous procedure

Child Anxiety Scale-State (CASsingle bondS). Its bottom resembles a lightbulb, and its horizontal lines with upward ranges like those of a thermometer. To measure state anxiety, the child is asked to say that he feels "now" It applied to kids ages 4 to 12 and had a range of 0 to 10. There is a direction in the scale "NOW color where you FEEL on the thermometer, too much tension or anxious, calm: not tension or anxious? Children were asked to "Pretend that all your worried or nervous feelings are in the very bottom down here (point to scale). If you are a little bit worried or nervous, the feelings might come up just a little bit (move your finger up). If you are very, very worried or nervous, the feelings might go all the way to the top (move your finger up to the top). Put a line showing how much worry or nervousness you feel." It ranges from 0 to 10 and can be applied to children aged 4-12. Reduce the child's anxiety during the peripheral intravenous catheterization procedure

Reducing the child's pain

时间窗: during peripheral intravenous procedure

This scale, which has six faceted expressions and assigns a pain score based on the numerical values of the faces, is used to diagnose pain in children. It is used to assess the pain in children three years and older. Faces can display a range of emotions, from crying (10 = most painful) to smiling (0 = no pain) reduce the child's pain during the peripheral intravenous catheterization procedure

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

Ayşe Kahraman

Assoc. Prof. Dr.

Ege University

研究点 (1)

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