The Effect of Virtual Reality Intervention on Pain Level, State Anxiety, and Vital Signs During Foot Care in Individuals With Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in Pain Level
研究概览
简要总结
This study aims to determine the effects of a virtual reality (VR) intervention on pain level, state anxiety, and vital signs during foot care in individuals with diabetic foot ulcers. The study was designed as a randomized controlled trial and includes 64 individuals with diabetes (intervention=32, control=32). The intervention group will receive VR during diabetic foot care, while the control group will receive standard care. Data will be collected at pre-test and post-test using the Demographic Information Form, Vital Signs Form, State-Trait Anxiety Inventory (STAI), and Visual Analog Scale (VAS) for pain. Data analysis will be performed using SPSS 22.0.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older Diagnosis of Type 2 Diabetes Mellitus Diabetic foot ulcer classified as Wagner stage 3 or 4 No mental or physical condition that would interfere with communication or participation No visual or hearing impairment Ability to understand and speak Turkish Willingness to participate in the study
排除标准
- •Presence of chronic wounds other than diabetic foot ulcer (e.g., arterial or venous ulcers) Age under 18 years
研究组 & 干预措施
Intervention Group (VR Group)
Participants received virtual reality (VR) intervention during diabetic foot care procedures in addition to standard care. VR was used as a non-pharmacological distraction method during the procedure.
干预措施: VR (Other)
Intervention Group (VR Group)
Participants received virtual reality (VR) intervention during diabetic foot care procedures in addition to standard care. VR was used as a non-pharmacological distraction method during the procedure.
干预措施: Standard Diabetic Foot Care (Other)
Control Group
Participants received standard diabetic foot care without virtual reality intervention.
干预措施: Standard Diabetic Foot Care (Other)
结局指标
主要结局
Change in Pain Level
时间窗: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
Pain intensity measured using the Visual Analog Scale (VAS), a 10 cm horizontal line anchored at 0 (no pain) and 10 (worst imaginable pain). Higher scores indicate greater pain. Change is calculated as post-test score minus pre-test score.
次要结局
- Change in State Anxiety(Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care)
研究者
Yasemin Özkul
Master's Student
Malatya Turgut Ozal University