The Effect of Virtual Reality Glasses on Anxiety During Surgery Under Spinal Anesthesia

Study Overview
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Brief Summary
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The aim of the study is to evaluate the efficacy of virtual reality glasses on anxiety of the patients who underwent operations under spinal anesthesia during peroperative period. Both control group and VR group will be carry out STAI- Traıt anxiety test before operation and trait test after operation. Patients will be perform spinal anesthesia after standard sedation administration. After block reach adequate level for operation patients in VR group will wear the glasses and started to watch a documentary about birds and a sedative music by the headset. Patients in Control group will take standard anesthesia care. Hemodynamic changes (systemic blood pressure, heart rate, respiration rate and pSPO2) will be record in both groups.

Detailed Description
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The ASA score I-III Patients undergoing operation in OR under spinal anesthesia will be included in the study. Patients randomly assigned to VR group or Control Group. Patients will be carry out STAI-Trait Anxiety test preoperatively and second STAI test postoperatively. Spinal anesthesia will be performed after standard iv midazolam administration in both groups. After block reach adequate level for operation patient will wear the glasses and started to watch a documentary about birds and a sedative music by the headset in VR group and patient will take standard anesthesia care in Control group. The hemodynamic variables will be recorded during operation.

Official Title
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The Effect of Virtual Reality Glasses on Anxiety During Surgery Under Spinal Anesthesia: A Randomize Controlled Study

Conditions
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VIRTUAL REALITY

Intervention / Treatment
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* Device: Virtual Reality
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 Patients who undergo surgery under spinal anesthesia American Society of Anesthesiologists (ASA) physical status classification I-III Exclusion Criteria: patients undergo urgent operations patients have psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR GROUP<br>Patients watches 3D documentary videos on virtual reality glasses | Device: Virtual Reality<br>* Patients will wear virtual reality glasses and start watching 3 D video after confirmation of adequate motor and sensorial block.<br>* Other names: VR;Drug: Midazolam<br>* 1-2 mg midazolam will be administered before spinal punction performed.<br>* Other names: Demizolam;|
| Active Comparator: midazolam<br>Patients do not watch virtual reality videos but will be administered iv sedative drugs before spinal attempt. | Drug: Midazolam<br>* 1-2 mg midazolam will be administered before spinal punction performed.<br>* Other names: Demizolam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State Anxiety Test | State Anxiety test will be perform at postop care unit | postoperative 20th min. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total tolerance time of Virtual Reality glasses | Total tolerance to VR glasses will be recorded | intraoperative | 
| incidence of vomiting | incidence of vomiting due to VR glasses | intraoperative | 
| incidence of nausea | incidence of nausea due to VR glasses | intraoperative | 
| incidence of dizziness | incidence of dizziness due to VR glasses | intraoperative | 
| incidence of headache | incidence of headache due to VR glasses | intraoperative | 
| Postoperative Visual Analog Scale Score | Patient will be asked his anxiety level by Visual analog scale (VAS) from 0 to 10. 0(= no anxiety), 10(= highest level of anxiety) | postoperative 20 th min. | 
| change in mean arterial pressure | blood pressure of the patient will be measured noninvasively from proper extremity in the operating room | 5th min. intraoperative | 
| change in mean arterial pressure | blood pressure of the patient will be measured noninvasively from proper extremity in the operating room | 10th min. intraoperative | 
| change in mean arterial pressure | blood pressure of the patient will be measured noninvasively from proper extremity in the operating room | 15th min. intraoperative | 
| change in mean arterial pressure | blood pressure of the patient will be measured noninvasively from proper extremity in the operating room | 20th min. intraoperative | 
| change in heart rate | heart rate of the patient will be monitored and recorded | 5th min. intraoperative | 
| change in heart rate | heart rate of the patient will be monitored and recorded | 10th min. intraoperative | 
| change in heart rate | heart rate of the patient will be monitored and recorded | 15th min. intraoperative | 
| change in heart rate | heart rate of the patient will be monitored and recorded | 20th min. intraoperative | 
| change in respiratory rate | respiratory rate of the patient will be monitored and recorded | 5th min. intraoperative | 
| change in respiratory rate | respiratory rate of the patient will be monitored and recorded | 10th min. intraoperative | 
| change in respiratory rate | respiratory rate of the patient will be monitored and recorded | 15th min. intraoperative | 
| change in respiratory rate | respiratory rate of the patient will be monitored and recorded | 20th min. intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VIRTUAL REALITY, ANXIETY, SPINAL ANESTHESIA