The Effects of Virtual Reality and Kaleidoscope on Pain and Fear During Blood Draw in Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Pain assesed by child, parent, nurse with Wong-Baker FACES
研究概览
简要总结
In literature review, many studies have been found to support the positive effects of various nonpharmacological methods in the alleviation of pain and fear created by invasive procedures.This study was carried out to determine the effects of kaleidoscope and cartoon watching using the virtual reality glasses on the pain and fear states of children during blood draw procedure.
详细描述
This study was carried out to determine the effects of kaleidoscope and cartoon watching using the virtual reality glasses on the pain and fear states of children during blood draw procedure.
H0: There are no significant differences in the mean pain and fear scores of the children who used kaleidoscope and cartoon watching using virtual reality glasses methods.
H1: Mean pain and fear score of the children who used kaleidoscope during blood draw procedure is lower than the ones who did not.
H2: Mean pain and fear score of the children who used virtual reality glasses during blood draw procedure is lower than the ones who did not.
This study was carried out with 7-12 year old children who were admitted to blood draw unit of a hospital in Turkey between January 21-April 21, 2020. Sample size was calculated as 156 including 52 individuals per each group in the study (52 in the kaleidoscope group, 52 in the virtual reality group and 52 in the control group). However, 2 children were lost in all groups due to the inability to draw blood with one entry and data were completed with a total of 150 children. Groups were generated by using randomization method. Participant Information Form: This form included sociodemographic characteristics (age, sex, presence of chronic disease) of the children.
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
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •being literate for the child and parent
- •being 7-12 years old
- •having no vision or hearing problems
- •having no chronic or mental health problem.
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.
- •having vision or hearing problems
- •having chronic or mental health problem.
结局指标
主要结局
Pain assesed by child, parent, nurse with Wong-Baker FACES
时间窗: during 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). 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).
Pain assesed by Visual Analohg Scale (VAS)
时间窗: during procedure
Visual Analog Scale (VAS): Visual Analog Scale, which is used to measure severity of pain consists of a horizontal or vertical ruler at a length of 10 cm or 100 mm which has "no pain" on one side and "the most severe pain possible" on the other side. While there is "no pain" expression on the left side of the ruler, there is "unberable pain" expression on the right side. VAS is described as understandable and easy-to-use for the children over 7 years old. Its validity and reliability have been shown in the previous studies
Fear assesed by The Children's Fear Scale (CFS)
时间窗: during procedure
This is a one-item self-report scale which is used to measure pain-associated fear. This one-item scale is composed of five neutral faces in terms of sex. There is a face showing no fear on the left and a face showing extreme fear on the right. The response of the evaluator shows the level of fear. It can be used by the parents and researchers before and during the procedure for the children aged 5-10 years old
次要结局
未报告次要终点
研究者
Esra TURAL BUYUK
Principal Investigator
Ondokuz Mayıs University