Evaluating the Efficacy of Virtual Reality in Patient Preparation for Cardiac Catheterization Procedures in Oman: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Change in pre-procedural anxiety (measured by DASS-21 Anxiety Subscale)
研究概览
简要总结
Background: Cardiovascular disease is considered one of the most prevalent diseases in recent times, and cardiac catheterization is widely used to diagnose and treat cardiovascular disease. However, patients often experience significant anxiety before the procedure due to fear of the unknown, potential complications, and concern about discomfort.Aim: To evaluate the efficacy of virtual reality technology to reduce anxiety and improve patient satisfaction, attitude, and usefulness in individuals undergoing first-time cardiac catheterization procedures in Oman.Method: A mixed-method randomized control trial will be used with approximately 120 patients from different tertiary hospitals in Oman. The experimental group will experience a virtual reality simulation of the catheterization process before providing informed consent, while the control group will receive the standard pre-procedure education. The Arabic version of the DASS-21 scale will be used to assess anxiety level pre- and post-intervention, while patient satisfaction will be measured through qualitative interviews with a subset of 10 participants.Result: ANOVA will be conducted to examine differences in anxiety and satisfaction scores between groups, and Pearson's correlation (r) will assess relationships between anxiety levels and satisfaction scores, while paired t-tests will be applied to compare anxiety levels before and after the intervention within groups. Additionally, multiple regression analysis will be employed to identify predictors of patient satisfaction and anxiety reduction, with a significance level set at p ≤ 0.05 for all statistical tests.Conclusion: The expected outcome of this study is that virtual reality-based education will significantly reduce pre-procedure anxiety and enhance patient satisfaction compared to standard education. Findings from this research may contribute to improving patient-centered care and developing innovative strategies to optimize emotional preparedness before cardiac catheterization procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and care providers will be aware of group allocation due to the nature of the intervention. However, the outcomes assessor analyzing the questionnaire data will be blinded to group assignment.
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Adult patients (aged 18 years and above)
- •Scheduled for first-time elective cardiac catheterization
- •Able to understand Arabic or English
- •Capable of providing informed consent
排除标准
- •• Individuals with cognitive impairment or psychiatric conditions that may interfere with their ability to engage in the VR intervention
- •Patients requiring emergency or urgent catheterization
结局指标
主要结局
Change in pre-procedural anxiety (measured by DASS-21 Anxiety Subscale)
时间窗: Baseline (before intervention) to immediately prior to cardiac catheterization (within 24 hours).
Anxiety will be assessed using the Depression, Anxiety and Stress Scale - 21 (DASS-21). The Anxiety subscale includes 7 items, each scored 0-3. Subscale scores are multiplied by 2, giving a final range of 0-42. Higher scores indicate greater anxiety.
次要结局
未报告次要终点
