An interventional study of Virtual Reality Glasses in Anxiety, sponsored by Mersin University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Mersin University · Not applicable, Interventional, and Supportive care
This randomized controlled trial evaluates the effect of virtual reality glasses applied during emergency surgical intervention with local anesthesia on patients anxiety. This study hypothesizes that virtual reality glasses reduces anxiety.
The sample of this study consisted of 138 patients in the experimental (n=69) and control groups (n=69). Virtual Reality (VR) application will be applied to the experimental group during the emergency surgical intervention under local anesthesia. Anxiety level will be assessed with the Spielberger State Anxiety Scale and measured by physiological responses of anxiety such as systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR) and peripheral oxygen saturation (SpO2) before and after VR application. In the control group, no application will be made except for standard care only.
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Exclusion Criteria:
VR application will be applied to the experimental group during the emergency surgical intervention under local anesthesia.
Device: Virtual Reality Glasses
The patients in the control group routinely receives standard care in the emergency service. No application will be made to the control group.
In addition to the routine practice of the emergency service, the virtual reality (VR) group will watch a video with VR glasses during the emergency surgical intervention under local anesthesia. Before the emergency surgery, the patients will be asked to wear a VR glasses compatible with mobile phones with android operating system and a headset that minimizes sound loss. Patients will be shown their preferred 3D licensed video software with relaxing music in the background. VR glasses will be put on the patients before starting the emergency surgical procedure under local anesthesia and applied until the procedure was completed. Patients will be asked to refill the The State Anxiety Inventory at the end of the emergency surgical intervention. At the same time, blood pressure, heart rate, respiratory rate, SpO2 values will be monitored on a portable monitor.
Anxiety evaluated using the State Anxiety Scale
Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also high.
Time frame: Change from baseline and ten minutes
Change systolic blood pressure
Determine patients physiological responses to anxiety (systolic blood pressure) before and after virtual reality application The researchers will measure the systolic blood pressure of the patients in the control group before and after emergency surgery with local anesthesia, and before and after the application to the experimental group after the virtual reality application. At the same time, systolic blood pressure values will be monitored on a portable monitor (8000c, Shenzhen Comen Medical Instruments Co., Ltd., China).
Time frame: During emergency surgery with Local Anesthesia
Change diastolic blood pressure
Determine patients' physiological responses to anxiety (diastolic blood pressure) before and after virtual reality application The researchers will measure the diastolic blood pressure of the patients in the control group before and after emergency surgery with local anesthesia, and before and after the application to the experimental group after the virtual reality application. At the same time, diastolic blood pressure values will be monitored on a portable monitor (8000c, Shenzhen Comen Medical Instruments Co., Ltd., China).
Time frame: During emergency surgery with Local Anesthesia
Change heart rate
Determine patients' physiological responses to anxiety (heart rate) before and after virtual reality application The researchers will measure heart rate of the patients in the control group before and after emergency surgery with local anesthesia, and before and after the application to the experimental group after the virtual reality application. At the same time, heart rate values will be monitored on a portable monitor (8000c, Shenzhen Comen Medical Instruments Co., Ltd., China).
Time frame: During emergency surgery with Local Anesthesia
Change respiratory rate
Determine patients' physiological responses to anxiety (respiratory rate) before and after virtual reality application The researchers will measure respiratory rate of the patients in the control group before and after emergency surgery with local anesthesia, and before and after the application to the experimental group after the virtual reality application. At the same time, respiratory rate values will be monitored on a portable monitor (8000c, Shenzhen Comen Medical Instruments Co., Ltd., China).
Time frame: During emergency surgery with Local Anesthesia
Change peripheral oxygen saturation
Determine patients' physiological responses to anxiety (peripheral oxygen saturation) before and after virtual reality application The researchers will measure peripheral oxygen saturation of the patients in the control group before and after emergency surgery with local anesthesia, and before and after the application to the experimental group after the virtual reality application. At the same time, peripheral oxygen saturation values will be monitored on a portable monitor (8000c, Shenzhen Comen Medical Instruments Co., Ltd., China).
Time frame: During emergency surgery with Local Anesthesia
Plan to share: No
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Mersin University