跳至主要内容
临床试验/NCT07249723
NCT07249723已完成不适用

Comparison of the Effectiveness of Two Active Distraction Methods in Reducing Pain, Fear, and Anxiety in Children Undergoing Venous Blood Sampling

Kocaeli University1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2025年4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
入组人数
207
试验地点
1
主要终点
Wong-Baker FACES Pain Rating Scale (WB-FACES)

研究概览

简要总结

This study was conducted to compare the effects of two active distraction methods-bubble blowing and a material-free cognitive distraction/positive reinforcement technique-applied during venous blood sampling on pain, fear, and anxiety levels in children aged 7-12 years.

详细描述

Distraction is an effective non-pharmacological nursing intervention used to reduce pain, fear, and anxiety in children during invasive procedures. This approach aims to decrease the child's emotional distress by diverting attention away from the perceived threat.

In particular, among children aged 7-12 years, procedure-related fear and avoidance behaviors may increase due to the impact of previous medical experiences; therefore, there is a need for comparative evaluation of effective distraction strategies tailored to this age group. While sensory-kinesthetic methods such as bubble blowing promote active participation, material-free cognitive techniques can be implemented in any setting and offer easily accessible options. However, studies directly comparing these methods remain limited.

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
Single (Outcomes Assessor)

盲法说明

Single (third party blinding- Outcomes Assessor)

入排标准

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

入选标准

  • •Aged between 7 and 12 years,
  • •Literate (able to read and write),
  • •Having no diagnosed visual, hearing, intellectual, or neurological disorder,
  • •With no history of analgesic, sedative, or narcotic use within 24 hours prior to admission,
  • •Children who, together with their parent, volunteered to participate.

排除标准

  • •Children who do not meet the inclusion criteria,
  • •Children or parents who wish to withdraw from the study at any stage,
  • •Children from whom a blood sample could not be obtained with a single venipuncture attempt.

研究组 & 干预措施

Bubble Blowing Group

Experimental

Before the procedure, each child was given a bubble toy and instructed to blow bubbles throughout the procedure. The procedure duration was recorded with a stopwatch. Post-procedural pain and anxiety were assessed using standardized scales. A single-use bubble toy was used for each child.

干预措施: Bubble Blowing Group (Other)

Positive Reinforcement Group

Experimental

Before the procedure, the researcher established communication with the child, and a short cognitive activity chosen by the child (e.g., counting numbers, word game) was implemented throughout the procedure. The parent provided physical and verbal support to the child. After the procedure, the child received verbal positive reinforcement.

干预措施: Positive Reinforcement Group (Other)

Standard Procedure Blood Sampling Group

No Intervention

Children in the control group underwent the standard blood sampling procedure in accordance with routine clinical practice. Outcome measurements were conducted after the procedure. Once data collection was completed, children in this group also received verbal feedback. All measurements were performed immediately before and after venipuncture. A single-needle insertion technique was used, and all blood draws were performed by the same pediatric nurse, who was permanently assigned to the unit, to ensure procedural standardization.

结局指标

主要结局

Wong-Baker FACES Pain Rating Scale (WB-FACES)

时间窗: A total of 2 evaluations will be made: before the procedure starts, the post-test immediately after the end of the procedure.

Developed by Wong and Baker (1988), this scale assesses pain intensity in children aged 3-18 years based on facial expressions, using a 0-5 scoring system. Pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale (0-10; higher scores indicate worse pain).

Children's Fear and Anxiety Scale (CFS)

时间窗: A total of 2 evaluations will be made: before the procedure starts, the post-test immediately after the end of the procedure.

Developed by McMurtry et al. (2011) and adapted into Turkish by Gerçeker et al. (2018), this scale evaluates fear and anxiety during the procedure on a 0-4 rating scale. 0-10; higher scores indicate greater fear and anxiety.

次要结局

  • Visual Analog Scale (VAS)(A total of 2 evaluations will be made: before the procedure starts, the post-test immediately after the end of the procedure.)

研究者

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

Sinem Yalnızoglu Caka

Assoc. Prof.

Kocaeli University

研究点 (1)

Loading locations...

相似试验