Effects of Virtual Reality on Pain, Fear and Anxiety During Blood Draw in Children Aged 5-12 Years Old: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Pain assesed by Wong-Baker FACES
研究概览
简要总结
Virtual Reality (VR) has firmly stood amongst other technological devices and can easily be adapted to clinical procedures due to its low cost. It can be easily used particularly in pediatric care units because it appeals to various age groups and can be adapted to mobile phones. Virtual Reality (VR) can be used during painful procedures in children. The aim of this study was to evaluate the effects of two different VR methods on procedure-related pain, fear and anxiety of children aged 5-12 years old during blood draw. This randomized controlled study used parallel trial design.
详细描述
Aim and Hypothesis
The aim of this study was to evaluate the effects of two different VR methods on procedure-related pain, fear and anxiety levels of children aged 5-12 years old during blood draw. The hypotheses of this study were to:
H1: Children in the two different VR groups will have significantly less procedure-related pain than those in the control group.
H2: Fear and anxiety scores of the children in the two different VR groups will be reduced than those in the control group.
Study sample This prospective, randomized controlled study was conducted at a university hospital special blood draw unit in Izmir, Turkey between September 2017 and November 2017. A parallel trial design was used describing two different VR groups (VR-Rollercoaster group and VR-Ocean Rift group) and a control group (no VR device used) as the third arm. Children aged 5-12-year-old who underwent blood draw were eligible to participate (n=136). This age group was selected because they were open to co-operation and more curious about technology.
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 (Participant)
盲法说明
Children Aged 5-12 Years Old
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 5-12-year-old who underwent blood draw procedure were eligible to participate in this study.
排除标准
- •Participants were excluded from the study if they were
- •refused to participate
- •had chronic or genetic diseases
- •had visual problem.
研究组 & 干预措施
VR-Rollercoaster
The children in the VR groups were told to watch the video by wearing virtual glasses during the blood draw. By wearing the VR headsets in the VR-Rollercoaster Group, individuals feel as if they are getting on and riding a rollercoaster. The rollercoaster speeds up and slows down.
干预措施: Children watch applications by wearing the virtual headset during the blood draw. (Behavioral)
VR-Ocean Rift
The children in the VR groups were told to watch the video by wearing virtual glasses during the blood draw. By wearing the VR headsets in the VR-Ocean Rift Group, individuals can take an underwater tour with 12 different marine animals with slow music.
干预措施: Children watch applications by wearing the virtual headset during the blood draw. (Behavioral)
Control
They would be monitored during the procedure if their informed consent was received. Control group children did not receive any distraction techniques.
结局指标
主要结局
Pain assesed by Wong-Baker FACES
时间窗: an average of 3 months
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). This scale was assessed using self-report and reports from the parents, the researcher and the nurse who attempted the blood draw after the blood draw procedure in this study.
次要结局
- Procedure Related Fear(an average of 3 months)
- Procedure Related Anxiety(an average of 3 months)
研究者
Gülçin Özalp Gerçeker
Asistant Professor
Dokuz Eylul University