The Effect of Virtual Reality Glasses Applied Before Coronary Angiography on Patients' Stress Levels, Muscle Tension, and Certain Physiological Parameters
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Physiological Parameters Monitoring Form
研究概览
简要总结
Today, cardiovascular diseases are the leading cause of morbidity and mortality worldwide. Coronary angiography (CAG), a commonly used invasive procedure for diagnosing coronary artery disease, may trigger fear, stress, and anxiety in patients due to its invasive nature, lack of information, uncertainty, and the possibility of receiving a life-threatening diagnosis.These emotional responses activate stress mechanisms, leading to catecholamine release, increased heart rate, blood pressure, respiration, sweating, and muscle tension. Elevated stress can also cause lactic acid accumulation, increased oxygen demand, and muscular contraction, potentially resulting in coronary artery spasms or arrhythmias, and increasing procedural risks. Therefore, reducing stress before CAG is crucial to improving procedural outcomes and patient recovery.
To address preoperative anxiety and stress, both pharmacologic and non-pharmacologic interventions are used. Among the non-pharmacologic options, virtual reality (VR) has emerged as an effective method to distract and calm patients, reducing anxiety, stress, and pain. Studies in various patient populations suggest VR glasses can be beneficial in managing psychological distress. However, no study has been found in the literature evaluating the effect of VR on stress-induced muscle tension in patients undergoing CAG. This gap highlights the potential contribution of this study to current knowledge.
This study aims to investigate the effect of using VR glasses before coronary angiography on patients' stress levels, muscle tension, and selected physiological parameters.
详细描述
Study Hypotheses:
H0: There is no difference in preoperative stress, muscle tension, or physiological parameters.
H1: There is a difference in preoperative stress levels. H2: There is a difference in preoperative muscle tension. H3: There is a difference in certain physiological parameters preoperatively. H4: There is a relationship between stress, muscle tension, and physiological parameters preoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age,
- •Scheduled to undergo CAG,
- •American Society of Anesthesiologists (ASA) score I or II,
- •Turkish-speaking patients will be included.
排除标准
- •Patients with nausea,
- •with dizziness,
- •with headache,
- •with any known psychiatric disease and mental perception problem,
- •pregnant,
- •with a history of epilepsy,
- •with vision, hearing and perception problems,
- •with closed space phobia,
- •with a history of dizziness, nausea, etc. due to previous virtual reality use will not be included in the study.
研究组 & 干预措施
Control Group
No intervention will be made to the patients outside of the hospital routine, and approximately 10 minutes before the procedure, the Physiological Parameters Monitoring Form, Distress Thermometer and VAS will be applied again and the data collection process will be completed.
干预措施: Standard application (Behavioral)
Experimental Group
In the preoperative period, approximately 1 hour before the procedure, a video will be watched for 15 minutes with virtual reality glasses. Approximately 10 minutes before the procedure, the patients will be administered the Physiological Parameters Monitoring Form, Distress Thermometer and VAS, and the data collection process will be completed.
干预措施: Intervention application with virtual reality glasses (Behavioral)
结局指标
主要结局
Physiological Parameters Monitoring Form
时间窗: Preoperative period
This form includes questions about patients' systolic and diastolic blood pressure
Distress Thermometer
时间窗: Preoperative period
It is a Likert-type scale with scores from 0 (no stress) to 10 (extreme stress) developed by Roth et al. (1998) to determine psychological distress in cancer patients. In the short and easy-to-understand scale, patients can easily mark their own stress levels within the specified ranges on the thermometer. The Turkish validity-reliability study of the Distress Thermometer was conducted by Özalp et al. (2007) . In their study, Özmen and Gürsoy (2021) concluded that the distress thermometer can be used as a valid and reliable measurement tool to measure the stress experienced by patients who will undergo surgery. With this scale, the stress levels of the patients in the last week and at the time of evaluation will be evaluated.
Assessment of Muscle Tension
时间窗: Preoperative period
Measuring patients' symptomatic experiences through questionnaires or self-reports is the gold standard method for assessing the presence and severity of a mental disorder. In a study conducted by Sainsbury and Gibson (1954) on symptoms reported by anxious, stressed patients, "feeling of tension" was mostly defined as "feeling of tension in the muscles," "muscle stiffness," "cramping," and "body discomfort" line with this information, the 10-point Visual Analogy Scale (VAS) will be used to assess muscle tension resulting from stress in patients before the CAG procedure, and patients will be asked to rate their feelings of tension in the muscles, stiffness in the muscles, cramping in any muscle, and inability to relax their body using this scale. This scale is 10 centimeters (cm) long and includes numbers from 0 to 10. The values marked by the patient between 0-10 cm on the scale will be ta
次要结局
- Physiological Parameters Monitoring Form(About 10 minutes before entering the process)
- Distress Thermometer(Approximately 10 minutes before the procedure, patients)
- Assessment of Muscle Tension(About 10 minutes before entering the process)
研究者
Aylin GÜÇLÜ DEMİREL
Assistant Professor (PhD)
Yuksek Ihtisas University