The Influence of Stress-inducing and Relaxing VR Content on Haematologic and Endocrinologic Blood Parameters in Healthy Participants - the 8baan Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The effect of relaxing VR content on von Willebrand ristocetin co-factor activity
研究概览
简要总结
The goal of this study is to learn what the impact of exposure to virtual reality content is on the levels of stress-related blood values in healthy volunteers. The main question it aims to answer is:
- To compare the levels of stress-related biomarkers before and after relaxing VR-content (Relax Visit);
- To compare the levels of stress-related biomarkers before and after stress-inducing VR-content (Rollercoaster Visit).
Researchers will compare the Relax and Rollercoaster Visit to see if there is a relationship between the relaxing and stress-inducing VR content on stress-related blood values.
Participants will be asked to watch relaxing or stress-inducing VR content for approximately five minutes. Blood will be withdrawn before and after intervention. After 3-5 weeks the study visit will be repeated using the other VR content.
详细描述
Rationale: In recent years virtual reality (VR) has become increasingly popular in clinical setting, especially during blood sampling to enhance patient comfort and reduce anxiety. The immersion in a 360° fantasy world contributes to an effective way of distraction. During a medical procedure the patient is allowed to choose a VR interface that corresponds his liking. This can consist in relaxing content, like meditation video's or swimming with dolphins, or stress-inducing content, like a rollercoaster ride. The latter might be problematic due to its potential influence on stress levels. Many laboratory tests, like haematologic and endocrinologic markers can be influenced during an acute stress response. Normally, this physiological process ensures an effective energy metabolism when most needed. However, during a blood withdrawal using stress-inducing VR this is inconvenient as it could theoretically result in elevated or inaccurate laboratory tests. This might lead to additional blood draws, misdiagnoses and potential over- or undertreatment of patients. To the best of our knowledge, no previous research has assessed the accuracy of laboratory tests conducted on blood samples drawn during a VR rollercoaster experience.
Objective: To assess the impact of exposure to relaxing and stress-inducing virtual reality content on the levels of stress-related biomarkers in healthy individuals.
Study design: This is a monocentre pilot cross-over clinical trial. Study participants will be randomly assigned to one of the two arms. These arms determine the order of VR content exposure. The first arm will be exposed to relaxing VR content during the first study visit, during which blood will be drawn before and after the VR experience. Then, after an interval of 3-5 weeks, they will be exposed to stress-inducing VR content and blood will be drawn before and after. The second arm will do the study visits in the opposite order.
Study population: Healthy volunteers between the ages of 18 and 45 years with no medical history on haematologic, endocrinologic or cardiac disorders.
Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 45 years old;
- •Willing and able to provide written informed consent.
排除标准
- •A history of motion- or cybersickness;
- •Fear of needles;
- •Any of the following haematological disorders:
- •Congenital or acquired haemophilia A;
- •Von Willebrand Disease.
- •Any of the following endocrinological disorders:
- •Thyroid disorders (e.g. hypo/hyperthyroidism);
- •Cushing syndrome;
- •Adrenal insufficiency;
- •Diabetes mellitus type 1 or 2;
- •Central or nephrogenic AVP deficiency.
- •A confirmed cardiac disorder;
- •All types of epilepsy;
- •Every form of medication, except for intermittent use of pain killers but not in the last week (e.g. paracetamol) and an intra-uterine device with or without contraceptive;
- •Pregnancy.
研究组 & 干预措施
Arm A
Arm A receives the Relax visit first and 3-5 weeks later the Rollercoaster Visit.
干预措施: Rollercoaster video (Other)
Arm B
Arm B receives the Rollercoaster Visit first and 3-5 weeks later the Relax Visit.
干预措施: Meditation video at the beach (Other)
Arm B
Arm B receives the Rollercoaster Visit first and 3-5 weeks later the Relax Visit.
干预措施: Rollercoaster video (Other)
Arm A
Arm A receives the Relax visit first and 3-5 weeks later the Rollercoaster Visit.
干预措施: Meditation video at the beach (Other)
结局指标
主要结局
The effect of relaxing VR content on von Willebrand ristocetin co-factor activity
时间窗: From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later)
The difference between von Willebrand ristocetin co-factor activity before and after relaxing VR content (beach meditation video) is measured.
The effect of stress-inducing VR content on von Willebrand ristocetin co-factor activity
时间窗: From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later)
The difference between von Willebrand ristocetin co-factor activity before and after stress-inducing VR content (rollercoaster ride) is measured.
The correlation between relaxing and stress-inducing VR content on von Willebrand ristocetin co-factor activity
时间窗: From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later)
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for von Willebrand ristocetin co-factor activity is assessed.
The effect of relaxing VR content on FVIII activity
时间窗: From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later)
The difference between FVIII activity before and after relaxing VR content (beach meditation video) is measured.
The effect of stress-inducing VR content on FVIII activity
时间窗: From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later)
The difference between FVIII activity before and after stress-inducing VR content (rollercoaster ride) is measured.
The correlation between relaxing and stress-inducing VR content on FVIII activity
时间窗: From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later)
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for FVIII activity is assessed.
The effect of relaxing VR content on copeptin
时间窗: From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later)
The difference between copeptin before and after relaxing VR content (beach meditation video) is measured.
The effect of stress-inducing VR content on copeptin
时间窗: From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later)
The difference between copeptin before and after stress-inducing VR content (rollercoaster ride) is measured.
The correlation between relaxing and stress-inducing VR content on copeptin
时间窗: From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later)
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for copeptin is assessed.
The effect of relaxing VR content on prolactin
时间窗: From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later)
The difference between prolactin before and after relaxing VR content (beach meditation video) is measured.
The effect of stress-inducing VR content on prolactin
时间窗: From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later)
The difference between prolactin before and after stress-inducing VR content (rollercoaster ride) is measured.
The correlation between relaxing and stress-inducing VR content on prolactin
时间窗: From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later)
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for prolactin is assessed.
The effect of relaxing VR content on thyroid stimulating hormone (TSH)
时间窗: From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later)
The difference between TSH before and after relaxing VR content (beach meditation video) is measured.
The effect of stress-inducing VR content on TSH
时间窗: From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later)
The difference between TSH before and after stress-inducing VR content (rollercoaster ride) is measured.
The correlation between relaxing and stress-inducing VR content on TSH
时间窗: From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later)
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for TSH is assessed.
The effect of relaxing VR content on cortisol
时间窗: From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later)
The difference between cortisol before and after relaxing VR content (beach meditation video) is measured.
The effect of stress-inducing VR content on cortisol
时间窗: From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later)
The difference between cortisol before and after stress-inducing VR content (rollercoaster ride) is measured.
The correlation between relaxing and stress-inducing VR content on cortisol
时间窗: From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later)
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for cortisol is assessed.
The effect of relaxing VR content on glucose
时间窗: From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later)
The difference between glucose before and after relaxing VR content (beach meditation video) is measured.
The effect of stress-inducing VR content on glucose
时间窗: From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later)
The difference between glucose before and after stress-inducing VR content (rollercoaster ride) is measured.
The correlation between relaxing and stress-inducing VR content on glucose
时间窗: From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later)
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for glucose is assessed.
次要结局
- The effect of relaxing VR-content on blood pressure(From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later))
- The effect of stress-inducing VR-content on blood pressure(From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later))
- The correlation between relaxing and stress-inducing VR content on blood pressure(From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later))
- The effect of relaxing VR-content on temperature(From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later))
- The effect of stress-inducing VR-content on temperature(From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later))
- The correlation between relaxing and stress-inducing VR content on temperature(From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later))
- The effect of relaxing VR-content on heart rate(From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later))
- The effect of stress-inducing VR-content on heart rate(From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later))
- The correlation between relaxing and stress-inducing VR content on heart rate(From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later))
- The effect of relaxing VR-content on respiratory rate(From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later))
- The effect of stress-inducing VR-content on respiratory rate(From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later))
- The correlation between relaxing and stress-inducing VR content on respiratory rate(From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later))
- The effect of relaxing VR content on subjective stress reported by participant(From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later))
- The effect of stress-inducing VR content on subjective stress reported by participant(From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later))
研究者
Van Creveldkliniek
Center for Benign Hematology, Thrombosis and Haemostasis
UMC Utrecht