Virtual Reality for Mindfulness and Anxiety Reduction in Fertility Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change in anxiety level before and after the intervention
研究概览
简要总结
This study aims to evaluate the effectiveness of a Virtual Reality (VR)-based mindfulness and meditation intervention in reducing anxiety among patients undergoing fertility-related surgical procedures. Anxiety is a common challenge in fertility treatments, often leading to emotional distress and increased pain perception. By incorporating a non-invasive VR intervention, the investigators seek to improve patient experience, minimize preoperative anxiety, and potentially reduce postoperative discomfort and recovery times. This randomized controlled trial (RCT) will compare standard care with a VR intervention in a clinical setting, measuring key outcomes such as anxiety levels, pain perception, recovery duration, and overall patient satisfaction. The findings may contribute to more patient centered fertility care, offering an innovative, scalable, and cost-effective approach to anxiety management in reproductive medicine.
详细描述
This study examines the effectiveness of a Virtual Reality (VR) mindfulness intervention in reducing anxiety for patients undergoing fertility surgeries. The trial will compare VR with standard care, measuring outcomes like anxiety, pain, recovery time, and patient satisfaction. The results could provide a cost-effective, patient-centered approach to managing anxiety in fertility treatments.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18-
- •Scheduled for fertility-related surgical procedures.
- •Able to provide informed consent.
排除标准
- •History of motion sickness or VR-related discomfort.
- •Cognitive or psychological conditions affecting participation.
- •Procedures requiring emergency intervention.
研究组 & 干预措施
Control Group (No VR intervention)
Patients will receive standard care without the VR intervention. Anxiety levels will be measured using the State-Trait Anxiety Inventory (STAI) before the procedure (baseline) and after the procedure.
Intervention Group (Virtual Reality Intervention)
Patients will experience the VR mindfulness intervention using the Tripp App or comparable applications.
Anxiety levels will be measured using the STAI before the VR experience, immediately after the VR experience, and after the procedure.
干预措施: Intervention Group (Virtual Reality intervention) (Device)
结局指标
主要结局
Change in anxiety level before and after the intervention
时间窗: 10 minutes before the procedure and 10 minutes after procedure (intervention group and control group)
Measured using the State-Trait Anxiety Inventory (STAI), which provides a score from 20 to 80. Higher scores indicate more anxiety. Change from baseline to post-procedure will be compared between VR and control groups. Score on STAI (range 20-80)
次要结局
- Recovery Time(30 minutes after the end of procedure (before discharge).)
- Visual Facial Anxiety Scale Score(10 minutes before the procedure and 10 minutes after procedure (intervention group and control group))
- Pain Score(Immediately post-procedure)
- Amount of Pain Medication Used(During and immediately after procedure)
- Composite Patient Satisfaction Score(30 minutes after the end of procedure (before discharge).)
- Gender-specific Effectiveness(Through study completion, an average of 1 year)
- Procedure-specific Effectiveness(Through study completion, an average of 1 year)
研究者
Laura Melado
Medical Director - Abu Dhabi
ART Fertility Clinics LLC