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 Blood will be withdrawn before and after intervention.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.
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: Participants will be exposed to stress-inducing and relaxing VR content during two separate study visits, the Relax Visit and the Rollercoaster Visit. Blood samples will be collected immediately before and after each VR session to measure changes in stress-related biomarkers. Additionally, objective stress levels measured by vital functions (e.g. heart rate, blood pressure) and subjective stress levels measured using a visual analogue scale (VAS) will be collected immediately pre- and post- VR exposure. Main study parameters/endpoints: The correlation between stress-related biomarkers (factor VIII activity, vWF ristocetin co-factor activity, copeptin (AVP), prolactin, thyroid stimulating hormone (TSH), cortisol and glucose) before and after relaxing and stress-inducing VR-content. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation includes two site visits, with an interval of 3 to 5 weeks. In both visits blood samples will be collected immediately before and after each VR session to measure changes in biomarkers. Additionally, objective stress levels measured by vital functions and subjective stress levels measured using a visual analogue scale will be collected immediately pre- and post- VR exposure. There are no benefits for participants. However, the results of this study may possibly benefit patients with haematological and endocrinological disorders regarding their comfort and anxiety during blood sampling and by reducing unnecessary extra sampling. Furthermore, it may benefit their treatment by optimizing the diagnostic process. Potential risks are the experience of motion-sickness during the VR experience and a blood withdrawal might be experienced as minimally painful for a very short amount of time. However, to minimalize this pain participants will apply a numbing cream one hour before the start of a study visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
A virtual reality video consisting of a 5 minute meditation video at te beach.
A virtual reality video consisting of a five minute rollercoaster ride.
University Medical Centre Utrecht
Utrecht, Netherlands
The effect of relaxing VR content on von Willebrand ristocetin co-factor activity
The difference between von Willebrand ristocetin co-factor activity before and after relaxing VR content (beach meditation video) is measured.
Time frame: 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 von Willebrand ristocetin co-factor activity
The difference between von Willebrand ristocetin co-factor activity before and after stress-inducing VR content (rollercoaster ride) is measured.
Time frame: 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 von Willebrand ristocetin co-factor activity
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for von Willebrand ristocetin co-factor activity is assessed.
Time frame: 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 FVIII activity
The difference between FVIII activity before and after relaxing VR content (beach meditation video) is measured.
Time frame: 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 FVIII activity
The difference between FVIII activity before and after stress-inducing VR content (rollercoaster ride) is measured.
Time frame: 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 FVIII activity
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for FVIII activity is assessed.
Time frame: 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 copeptin
The difference between copeptin before and after relaxing VR content (beach meditation video) is measured.
Time frame: 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 copeptin
The difference between copeptin before and after stress-inducing VR content (rollercoaster ride) is measured.
Time frame: 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 copeptin
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for copeptin is assessed.
Time frame: 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 prolactin
The difference between prolactin before and after relaxing VR content (beach meditation video) is measured.
Time frame: 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 prolactin
The difference between prolactin before and after stress-inducing VR content (rollercoaster ride) is measured.
Time frame: 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 prolactin
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for prolactin is assessed.
Time frame: 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 thyroid stimulating hormone (TSH)
The difference between TSH before and after relaxing VR content (beach meditation video) is measured.
Time frame: 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 TSH
The difference between TSH before and after stress-inducing VR content (rollercoaster ride) is measured.
Time frame: 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 TSH
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for TSH is assessed.
Time frame: 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 cortisol
The difference between cortisol before and after relaxing VR content (beach meditation video) is measured.
Time frame: 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 cortisol
The difference between cortisol before and after stress-inducing VR content (rollercoaster ride) is measured.
Time frame: 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 cortisol
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for cortisol is assessed.
Time frame: 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 glucose
The difference between glucose before and after relaxing VR content (beach meditation video) is measured.
Time frame: 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 glucose
The difference between glucose before and after stress-inducing VR content (rollercoaster ride) is measured.
Time frame: 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 glucose
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for glucose is assessed.
Time frame: 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 blood pressure
The difference before and after relaxing VR-content (beach meditation video) on blood pressure
Time frame: 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
The difference before and after stress-inducing VR-content (rollercoaster ride video) on blood pressure
Time frame: 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
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for blood pressure is assessed.
Time frame: 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
The difference before and after relaxing VR-content (beach meditation video) on temperature
Time frame: 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
The difference before and after stress-inducing VR-content (rollercoaster ride video) on temperature
Time frame: 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
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for temperature is assessed.
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Time frame: 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
The difference before and after relaxing VR-content (beach meditation video) on heart rate
Time frame: 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
The difference before and after stress-inducing VR-content (rollercoaster ride video) on heart rate
Time frame: 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
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for heart rate is assessed.
Time frame: 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
The difference before and after relaxing VR-content (beach meditation video) on respiratory rate
Time frame: 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
The difference before and after stress-inducing VR-content (rollercoaster ride video) on respiratory rate
Time frame: 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
The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for respiratory rate is assessed.
Time frame: 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
Subjective stress, measured by a visual analogue scale (VAS) (scale 0-10 made visual using different faces; 0 being no stress, 10 being the worst stress a person can imagine), during relaxing VR content (beach meditation video).
Time frame: 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
Subjective stress, measured by a visual analogue scale (VAS) (scale 0-10 made visual using different faces; 0 being no stress, 10 being the worst stress a person can imagine), during relaxing VR content (rollercoaster ride video).
Time frame: 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)