The Effect of Virtual Reality Headset Use on Pain, Comfort, and Psychosocial Symptoms in Children Undergoing Hypospadias Surgery: 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
- 62
- 试验地点
- 1
- 主要终点
- wong-baker faces scale
研究概览
简要总结
The aim of this study is to examine the effect of virtual reality glasses use on pain, comfort, and psychosocial symptoms in children after hypospadias surgery.
详细描述
This research was conducted as a randomized controlled trial, with a sample consisting of 62 pediatric patients (intervention group = 31, control group = 31) undergoing hypospadias surgery. Virtual reality headsets were administered to the intervention group postoperatively, while the control group received routine care. Data were collected using a Descriptive Information Form, the Wong-Baker FACES Scale, the Pediatric Comfort Assessment Scale, and the Psychosocial Symptom Identification Scale for Hospitalized Children. Data were analyzed using the IBM SPSS Statistics 22.0 software package. Descriptive statistics, independent samples t-test, chi-square test, and mixed-design repeated measures analysis were employed for data analysis. Statistical significance was set at p<0.05.
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 (Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants must provide written and verbal informed consent from their parents for participation in the study, and be male children aged 6-12 who have undergone hypospadias surgery.
排除标准
- •Having an auditory, mental, neurological, or visual impairment/problem severe enough to prevent VR glasses use, using an additional analgesic outside of the standard protocol within the first hour after surgery, or experiencing nausea, dizziness, or excessive panic reactions related to the virtual reality glasses during the procedure.
研究组 & 干预措施
control group
routine clinical practice
干预措施: routine clinical practice (Other)
intervention group
playing a 15-minute game through virtual reality glasses
干预措施: Virtual reality headset (Device)
结局指标
主要结局
wong-baker faces scale
时间窗: 1 hour after surgery/before and after application/2 times a day/10-15 minutes
The assessment was conducted using the Wong-Baker Faces Scale. On the scale, the lowest score is "0" and the highest is "10." Pain intensity increases as the score rises. When administering the scale, an explanation is provided to the child using facial expressions, and the child is asked to select the expression that best reflects their condition. The scale scores are interpreted as follows: 0 = no pain; 2 = mild pain; 4 = some pain; 6 = distinct pain; 8 = severe pain; and 10 = unbearable pain.
pediatric comfort assessment scale
时间窗: 1 hour after surgery/before and after application/2 times a day/10-15 minutes
The assessment was conducted using the pediatric comfort assessment scale. It evaluates 5 parameters: sounds, motor movements, performance, facial expressions and other. Each item is evaluated on a 5-point Likert scale from 0 to 4 (0/Not Available, 1/No, 2/Somewhat, 3/Moderate, 4/Strong) from bad to good. Higher scores indicate a higher level of comfort.
次要结局
- Psychosocial symptom assessment scale for hospitalized children(1 hour after surgery/before and after application/2 times a day/10-15 minutes)
研究者
aysel kokcudogan
Ph.D., Asst. Prof.
Istanbul Medipol University Hospital