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

Not Applicable

Completed

• Conditions: VIRTUAL REALITY
• Interventions: Device: Virtual Reality; Drug: Midazolam

• Registration Number: NCT03475810
• Lead Sponsor: Derince Training and Research Hospital

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-11-07
• Study First Submitted: 2018-03-17
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-23
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age >18
• Patients who undergo surgery under spinal anesthesia
• American Society of Anesthesiologists (ASA) physical status classification I-III

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Exclusion Criteria

• patients undergo urgent operations
• patients have psychiatric disorders

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR GROUP	Virtual Reality	Patients watches 3D documentary videos on virtual reality glasses
VR GROUP	Midazolam	Patients watches 3D documentary videos on virtual reality glasses
midazolam	Midazolam	Patients do not watch virtual reality videos but will be administered iv sedative drugs before spinal attempt.

Primary Outcome Measures

Name	Time	Method
State Anxiety Test	postoperative 20th min.	State Anxiety test will be perform at postop care unit

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Derince Research and Training Hospital; 🇹🇷 Kocaeli, Turkey