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临床试验/NCT05319210
NCT05319210Unknown不适用

Investigation of the Effect of Virtual Reality Glasses and Buzzy Application on Pain Management During Venous Catheter Insertion in Children

Suleyman Demirel University2 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
2
主要终点
Pain management

研究概览

简要总结

The purpose of this research; This is a randomized controlled experimental study planned to examine the effect of virtual reality glasses and buzzy application on pain management during venous catheter insertion in children.

详细描述

The purpose of this research; This is a randomized controlled experimental study planned to examine the effect of virtual reality glasses and buzzy application on pain management during venous catheter insertion in children.

The universe of the research is all children between the ages of 7 and 12 who applied to Hospital Emergency Service will be formed. G power analysis program was used to calculate the sample size of the study. The number of samples was calculated according to 95% power, 0.05 margin of error and 0.80 effect size. It is envisaged that 36 children will be included in the sample for each group. However, considering that sample losses may be experienced during the process of the research, it is planned to include 40 participants (120 participants in total) for each group.

"Child and Parent Diagnosis Form", "Child Fear Scale (CDS)", "Child Anxiety Scale-State (CAS-D)" and Wong-Baker Faces Pain Scale will be used to collect research data.

In the collection of research data, first of all, patients will be divided into intervention and control groups in accordance with the randomization scheme. Our research will consist of two interventions (Buzzy device, virtual reality glasses) and a control group (routine outpatient procedures).

Before the procedure; Written and verbal "Informed Consent" will be obtained from all participants in the intervention and control groups. "Child and Parent Diagnosis Form", "Child Fear Scale (CDS)", "Child Anxiety Scale-State (CAS-D)" and Wong-Baker Faces Pain Scale will be applied to the participants who agree to participate in the study.

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
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Those who volunteered to participate in the research
  • 7-12 age group
  • The child does not have vision, hearing, mental or neurological sequelae.

排除标准

  • Children with a history of using sedative, analgesic or narcotic substances with analgesic effect before admission to the outpatient clinic will not be included in the study.

结局指标

主要结局

Pain management

时间窗: 4 month

Management of pain during venous catheter insertion in children. The parameter for pain management will be determined by the Wong Baker Faces Pain Rating Scale.

次要结局

  • Management of fear in children(4 month)
  • Management of anxiety in children(4 month)

研究者

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

Serife Tutar

Principal investigator

Suleyman Demirel University

研究点 (2)

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