The Effect of Virtual Reality Glasses Applied During Emergency Surgical Intervention With Local Anesthesia on Patients Anxiety
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mersin University
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- Anxiety evaluated using the State Anxiety Scale
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
The researchers will involve in the data analysis and statistics stages will blind to the group assignment. Patients in study can not be blinded. Also, the person who performed the measurements cannot be blinded due to the nature of VR application. A statistician will analyze the data, and the findings will be reported.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Emergency surgical intervention with local anesthesia,
- •Between the ages of 18-65,
- •Conscious, oriented and cooperative,
- •Able to read and understand Turkish,
- •Agree to participate in the study
- •Does not have physical problems that will prevent the application of virtual reality glasses,
- •No previous experience with virtual reality glasses,
- •Not diagnosed with anxiety,
- •Does not use drugs for anxiety,
- •Does not use alcohol and/or drugs,
- •No mental illness
- •Patients who signed the Informed Consent Form/Written Consent Form
Exclusion Criteria
- •No emergency surgical intervention with local anesthesia,
- •Those under the age of 18, over the age of 65,
- •Unconscious, oriented and uncooperative,
- •Can't read and understand Turkish,
- •Those who do not agree to participate in the study,
- •Having a physical problem that will prevent the application of virtual reality glasses,
- •Diagnosed with anxiety,
- •Using drugs for anxiety (anxiolytic, antidepressant, antipsychotic, etc.),
- •Using alcohol and/or drugs,
- •Having a mental disorder,
- •Patients who did not sign the Informed Consent Form/Written Consent Form
Arms & Interventions
Virtual Reality application group
VR application will be applied to the experimental group during the emergency surgical intervention under local anesthesia.
Intervention: Virtual Reality Glasses (Device)
Control
The patients in the control group routinely receives standard care in the emergency service. No application will be made to the control group.
Outcomes
Primary Outcomes
Anxiety evaluated using the State Anxiety Scale
Time Frame: Change from baseline and ten minutes
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.
Secondary Outcomes
- Change diastolic blood pressure(During emergency surgery with Local Anesthesia)
- Change heart rate(During emergency surgery with Local Anesthesia)
- Change systolic blood pressure(During emergency surgery with Local Anesthesia)
- Change respiratory rate(During emergency surgery with Local Anesthesia)
- Change peripheral oxygen saturation(During emergency surgery with Local Anesthesia)
Investigators
Merve TOPAL
Nurse
Mersin University