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Clinical Trials/NCT03475810
NCT03475810
Completed
Not Applicable

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

Derince Training and Research Hospital1 site in 1 country100 target enrollmentNovember 7, 2017

Overview

Phase
Not Applicable
Intervention
Virtual Reality
Conditions
VIRTUAL REALITY
Sponsor
Derince Training and Research Hospital
Enrollment
100
Locations
1
Primary Endpoint
State Anxiety Test
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 7, 2017
End Date
July 1, 2018
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Derince Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ayse Zeynep Turan

Principle Investigator

Derince Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Arms & Interventions

VR GROUP

Patients watches 3D documentary videos on virtual reality glasses

Intervention: Virtual Reality

VR GROUP

Patients watches 3D documentary videos on virtual reality glasses

Intervention: Midazolam

midazolam

Patients do not watch virtual reality videos but will be administered iv sedative drugs before spinal attempt.

Intervention: Midazolam

Outcomes

Primary Outcomes

State Anxiety Test

Time Frame: postoperative 20th min.

State Anxiety test will be perform at postop care unit

Secondary Outcomes

  • Total tolerance time of Virtual Reality glasses(intraoperative)
  • incidence of vomiting(intraoperative)
  • incidence of nausea(intraoperative)
  • incidence of dizziness(intraoperative)
  • incidence of headache(intraoperative)
  • change in respiratory rate(20th min. intraoperative)
  • Postoperative Visual Analog Scale Score(postoperative 20 th min.)
  • change in mean arterial pressure(20th min. intraoperative)
  • change in heart rate(20th min. intraoperative)

Study Sites (1)

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