The Effect of Virtual Reality Glasses on Perceived Pain and State Anxiety Levels During Intrauterine Device Insertion: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pain insensity during IUD insertion
研究概览
简要总结
This study aims to evaluate the effect of virtual reality glasses on pain perception and anxiety levels during intrauterine device insertion in women. Participants undergoing intrauterine device insertion will be randomly assigned to either a virtual reality invervention group or a standard care control group. Pain intensity and anxiety levels will be assessed during and after the procedure using validated measurement tools. The findings of this study may contribute to improving patient comfort during intrauterine device insertion.
详细描述
This randomized controlled study will be conducted among women scheduled for intrauterine device insertion. Eligible participants will be randomly allocated into two groups: a virtual reality intervention group and a control group receiving standard care. Participants in the intervention group will be use virtual reality glasses during the intrauterine device insertion procedure, while the control group will undergo the procedure without virtual reality. Pain intensity will be measured using a validated pain scale during and after the procedure. Anxiety levels will be assessed using a validated state anxiety measurement tool. Sociodemographic and clinical characteristics of participants will also be recorded. The study will be conducted in accordance with ethical principles, and informed consent will be obtained from all participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Those aged 18-49
- •Those who understand and speak Turkish
- •Those without visual or hearing impairments
- •Women who agree to participate in the study
- •Those with adequate mental and emotional health
- •Those who will undergo a copper intrauterine device (IUD)
排除标准
- •Those outside the 18-49 age range
- •Those who do not speak Turkish
- •Those with visual, hearing, or speech impairments
- •Those with diagnosed psychiatric illnesses
- •Those taking psychiatric medications
研究组 & 干预措施
Virtual Reality Group
Participants will wear a VR headset during IUD insertion for pain and anxiety distraction
干预措施: Virtual Reality Headset (Device)
Control Group
Participants will receive standard care during IUD insertion without VR intervention
结局指标
主要结局
Pain insensity during IUD insertion
时间窗: İmmediately after the procedure
Pain severity will be measured immediately after the IUD insertion procedure using the Visual Analog Scale
Pain catastrophizing(Pain Catastrophizing Scale, PCS)
时间窗: İmmediately after the procedure
Pain catastrophizing will be assessed immediatel the IUD insertion procedure using the Pain Catastrophizing Scale(PCS;13 items). Higher scores indicate greater catastrophizing.
State Anxiety level(STAI-S)
时间窗: İmmediately after the procedure
State anxiety will be measured immediately after the procedure using the State-Trait Anxiety Inventory- State Subscale(STAI-S). Higher scores indicate greater anxiety.
次要结局
未报告次要终点
研究者
Serap Ozturk Altinayak
Associate Professor
Ondokuz Mayıs University