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临床试验/NCT07299058
NCT07299058尚未招募不适用

The Effect of a Guessing Game on Fear, Pain, and Emotional State During Blood Collection in Children Aged 6-12

Dokuz Eylul University0 个研究点目标入组 70 人开始时间: 2025年12月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
Pain assessment will be measured using a pain scale. The scale is scored from 0 to 10. The higher the score, the greater the pain.

研究概览

简要总结

The aim of this study is to evaluate the effects of a guessing game on fear, pain and emotional state during blood collection in children aged 6-12 years.

详细描述

Invasive medical procedures, particularly blood draws, are among the most common healthcare procedures in which children experience intense fear, pain, and emotional stress. The literature contains numerous studies on distraction interventions designed to improve children's psychological well-being and reduce the traumatic effects of these procedures. However, the majority of these studies have focused on passive distraction techniques (e.g., watching videos or listening to music), with less emphasis on play-based interventions that involve active child participation (Uman et al., 2013; Koller & Goldman, 2012). A meta-analysis by Birnie et al. (2018) demonstrated that distraction and techniques such as hypnosis are effective in reducing pain and anxiety associated with needle injections in children. Distraction-based approaches, in particular, have been reported to divert children's cognitive capacity from directing the procedure, leading to more positive emotional responses. A review of studies conducted in this area in Turkey reveals that methods such as distraction with music (Özdemir & Karakoç, 2017), blowing bubbles (Karaman & Selimen, 2015), and playing with toys have generally been evaluated. However, studies systematically examining play-based distraction practices that utilize children's cognitive functions such as decision-making, choice, and direction in the field of nursing are rare. A randomized controlled trial conducted by Hacettepe University found that a combination of information provision and an active distraction method (a tablet puzzle game) reduced both pain and fear levels in children (p=0.001-0.005) (Isıyel et al., 2023). Randomized controlled trials in the international literature demonstrate that playing video games, virtual reality, or using interactive technology (e.g., tablet games, VR modules) significantly reduces pain and anxiety during blood collection (Inan & Inal, 2019). | However, these studies often utilize passive or semi-passive distraction applications tailored to age, while predictive game designs that focus entirely on one-on-one interaction with the child are rarely featured in the literature. To this end, this study will evaluate the "Effect of a Guessing Game on Fear, Pain, and Emotional State During Blood Collection in Children Aged 6-12."

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 (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Being between 6 and 12 years of age
  • Not having a previous diagnosis of a serious hematological/psychiatric disease
  • The child and parent must be willing to participate in the study
  • Being able to speak and understand Turkish

排除标准

  • Having received sedation, analgesics, or anxiolytic medication during the procedure
  • Having a visual/hearing impairment
  • Having previously undergone an invasive procedure on the same day

结局指标

主要结局

Pain assessment will be measured using a pain scale. The scale is scored from 0 to 10. The higher the score, the greater the pain.

时间窗: Months 1-2 of the study

Fear assessment will be measured using a fear scale. The scale is scored from 0 to 4. Higher scores indicate higher fear.

时间窗: Months 1-2 of the study

Emotional outlook assessment will be measured using the Emotional State Scale. The scale is scored from 5 to 25. Higher scores indicate higher negative emotional states.

时间窗: Months 1-2 of the study

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

İlknur Bektaş

Academic staff

Dokuz Eylul University

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