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临床试验/NCT05161416
NCT05161416已完成不适用

Comparison of the Effects of Cartoon Watching and Bubble Blowing as Distraction Methods During Venipuncture on Pain, Fear, and Anxiety in Children Aged 6-8 Years: A Randomized Experimental Study

Mersin University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2019年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Anxiety assesed by Children's State Anxiety Scale

研究概览

简要总结

Active and passive distraction methods are frequently used in the nursing management of procedural pain in children. There are no studies comparing the effects of cartoon watching (passive) and bubble blowing (active) as distraction methods on pain, anxiety, and fear associated with venipuncture in children.

This study aimed to compare the effects of bubble blowing (active distraction) and cartoon watching (passive distraction) techniques on pain, anxiety, and fear during venipuncture in children aged 6-8 years.

详细描述

Research Hypotheses H1a= There is a difference in the mean WB-FACES score during the procedure between the bubble group (BG) and the cartoon group (CG).

H1b= There is a difference in the mean WB-FACES score after the procedure between the BG and CG groups.

H2a= There is a difference in the mean CSA score during the procedure between the BG and CG groups.

H2b= There is a difference in the mean CSA score after the procedure between the BG and CG groups.

H3a= There is a difference in the mean CFS score during the procedure between the BG and CG groups.

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
Double (Participant, Outcomes Assessor)

盲法说明

The children and their parents were blinded to the groups. The principal researchers (R2, R3) were blinded to the research hypotheses. Data entry researchers (R4, R5, R6) were blinded (masked) to both research hypotheses and intervention groups. Data entries (R4, R5) were performed using the codes A and B, and shared with the researchers (R1, R7, R8) after statistical analyses were conducted and the research report was written.

入排标准

年龄范围
6 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child aged 6-8 years
  • Child with need or plan for venipuncture (antecubital fossa)

排除标准

  • Child with a neurodegenerative disease, mental retardation, vision and hearing problems, chronic, life-threatening (sepsis, shock, respiratory / cardiac arrest) or genetic disease
  • Child with use of opioids, narcotics, analgesics or sedatives in the last 24 hours before the procedure

结局指标

主要结局

Anxiety assesed by Children's State Anxiety Scale

时间窗: Procedure (during the venipuncture)

The Children's State Anxiety Scale assesses children's anxiety. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety.

Fear by Children's Fear Scale

时间窗: Procedure (during the venipuncture)

The Child Fear Scale was used.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to 4 (extreme fear). Higher scores mean a worse outcome.

Pain assesed by Wong-Baker FACES

时间窗: Procedure (during the venipuncture)

The Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).

次要结局

  • Fear by Children's Fear Scale(After procedure (at 3rd minutes after the venipuncture))
  • Anxiety assesed by Children's State Anxiety Scale(After procedure (at 3rd minutes after the venipuncture))
  • Pain assesed by Wong-Baker FACES(After procedure (at 3rd minutes after the venipuncture))

研究者

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

Guzide UGUCU

Res. Asst., RN, MScN, PhD Candidate

Mersin University

研究点 (2)

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