The Effect of Virtual Reality and Cold Vibration Device on First Attempt Success, Procedure-Related Fear, Anxiety and Pain During Pediatric Intravenous Line Placement in Children Between 4-10 Years Old in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Fear assesed by Child Fear Scale
研究概览
简要总结
Studies evaluating VR are quite insufficient. In the study we determined in the emergency room between the ages of 4-10, cold vibration and virtual reality will be compared, and the success of the first attempt, pain, fear and anxiety will be evaluated.
详细描述
It was planned to evaluate the effect of virtual reality, cold vibration device application on the first attempt success, procedure-related pain, fear and anxiety during pediatric intravenous line placement in children aged 4-10 years in the pediatric emergency unit.
H1: Patients who watch videos with virtual reality glasses or who are applied cold vibration device during the vascular access procedure have a high first-attempt success.
H2: The pain, fear, and anxiety scores of the patients who watch videos with virtual reality glasses or who are applied cold vibration device during the venipuncture procedure are lower.
It is planned to include children between the ages of 4 and 10 who will be given vascular access in the Dokuz Eylül University Pediatric Emergency Unit. Between December 2020 and January 2021, it is planned to include patients selected by stratified randomization method in accordance with the sampling criteria. In the Gpower statistical program, based on the results of one-way variance analysis used in the comparison of pain and anxiety scores in the study of Canbulat et al. It was determined that a sample was required. In the study, it was planned to fulfill the parametric test assumptions and to have 50 children for each group and 150 children for the total sample, considering 10% loss.
Inclusion / exclusion criteria 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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of 4-10
- •The child agrees to voluntarily participate in the study.
- •Parents agree to voluntarily participate in the study
- •Obtaining consent form from the child and parent
排除标准
- •- The child with physical and psychological deficit to prevent him from wearing the glasses to be worn on his head so that he can watch virtual reality.
结局指标
主要结局
Fear assesed by Child Fear Scale
时间窗: during the procedure
The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater responds indicates the level of fear. It can be used during the procedure for children aged 5-10 years.
Pain assesed by Wong-Baker FACES
时间窗: during the procedure
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).
Anxiety assesed by Children Anxiety Meter-State
时间窗: during the procedure
The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. 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
次要结局
- Emotional Appearance Scale for Children(Baseline (before the procedure))
研究者
Gülçin Özalp Gerçeker
Assoc. Prof.
Dokuz Eylul University