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

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

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.

Study Overview

• Status: Completed
• Conditions: VIRTUAL REALITY
• Intervention / Treatment: Device: Virtual Reality; Drug: Midazolam

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey, 41900
    • Derince Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Derince Training and Research Hospital
• Investigators: Principal Investigator: Ayse Zeynep Turan, MD, Derince Research and Training Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2017
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: March 17, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: VIRTUAL REALITY; ANXIETY; SPINAL ANESTHESIA
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: DerinceTRH-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No