Efficacy of Immersive Entertainement Glasses in Magnetic Resonance Imaging to Reduce Claustrofobia: Clinical Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Anxiety reduction
研究概览
简要总结
Background: Claustrophobia is the most common type of specific phobia, and in the context of performing an MRI, it leads to premature completion of the test or a sedation. According to some authors, 1,6% of the patients terminated the test prematurely due to claustrophobia, and, in addition, 3.8% underwent conscious sedation. These procedures increase the risk of complications, and the cost of care. The use of anxiolytics is an option to reduce anxiety, but these drugs carry the possibility of suffering adverse effects, and the fact that patients cannot drive home when the MRI is finished. For these reasons, it is especially relevant to determine which non-pharmacological interventions are most effective, and among them, the use of Immersive Entertainment Glasses is a low-interventionist option that can help to overcome fear of the test.
Objective: To determine the effectiveness of Immersive Entertainment Glasses in the success of the performance of an MRI and in the reduction of anxiety levels, in patients who express having claustrophobia.
Methodology:
Design: Clinical trial with intervention and control group. Participants: patients who define themselves as claustrophobic and should have an MRI. The sample will be made up of 206 individuals, divided between an intervention group and a control group. expecting a 20% difference between the success of the test of the control and intervention group subjects.
People who meet the inclusion criteria will be distributed into the control or intervention group. The intervention group will use the Immersive Entertainment Glasses to perform the MRI and the control group will have the support of the nurse through educational techniques.
Expected results: the success rate in performing MRIs is expected to increase by 20%, thanks to the use of Immersive Entertainment Glasses.
Expected duration: 12 months, or until obtaining the expected sample.
详细描述
INTRODUCTION According to the Diagnostic and Statistical Manual of Mental Disorders (DSM V), there are many categories of anxiety disorders. The specific phobias are a type of disorder where there is an extreme fear of people, objects, or specific situations. Among the most common symptoms are physical and emotional ones. Physical symptoms may include, but are not limited to, shortness of breath, trembling, sweating, tachycardia, dry mouth, and chest pain. The most frequent emotional symptoms are feeling overwhelmed by anxiety or fear, presenting fear of losing control, needing to leave the place that causes anxiety and understanding that it is an irrational fear but not being able to avoid it. According to some authors, the specific disorders in the Korean population are between 5.2% and 4.2%.
Among the different phobias, claustrophobia is the most common. This is a situational phobia and consists of an irrational fear that occurs when the person is in closed spaces such as an elevator, a tunnel, or some radiological test equipment such as an MRI. The person has an intense and irrational fear of being confined in a small space and not being able to escape.
This situation has an implication from the point of view of public health because these people are sometimes unable to undergo an MRI since, in addition, they must be about 30 minutes still in a small space. Therefore, this type of disorder leads on numerous occasions to the cancellation of the test, or to a premature termination, causing damage to the patient's health since, either the MRI is not performed, or they must undergo sedation or anesthesia.
Magnetic resonance imaging is very useful in the detection and characterization of lesions. Some authors state that 37% of people who undergo an MRI have moderate to intense levels of anxiety. The prevalence of claustrophobia in the population is between 7.7% and 12.5%, although the frequency is higher among the female sex Approximately 1% of the population that requires an MRI rejects its performance or terminates it prematurely due to claustrophobia. Some researchers claim that 1.6% of patients finished the test prematurely due to claustrophobia, and, in addition, 3.8% underwent conscious sedation. These procedures increase the risk of complications, and in addition they increase the cost.
The most common therapy to treat claustrophobia is cognitive behavioral therapy, with gradual exposure to closed or narrow spaces being the most widespread treatment.
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 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with self-reported fear of enclosed spaces
- •Patients with fear of having an MRI
排除标准
- •Patients who must undergo a sustained breathing exploration during the test
- •Patients who have a contraindicated MRI
- •Pregnant women
结局指标
主要结局
Anxiety reduction
时间窗: One hour
Decrease of the levels of anxiety measured with the State Trait Anxiety Inventory (STAI)
Succes in the performance of an MRI
时间窗: One hour
Number of patients that will finish the MRI
次要结局
- Patient satisfaction(One hour)
- Image quality(Half an hour)
- Failed MRI(One hour)
