The Effect of Virtual Reality Glasses Applied During Emergency Surgical Intervention

NCT05253274 | Completed DMC

• 1 other identifier: MersinUn
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Anxiety; Virtual reality glasses; Emergency Surgery

Outcome Measures

Primary Outcomes (1)

• Anxiety evaluated using the State Anxiety Scale

  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.

  Change from baseline and ten minutes

Secondary Outcomes (5)

• Change systolic blood pressure

  During emergency surgery with Local Anesthesia

• Change diastolic blood pressure

  During emergency surgery with Local Anesthesia

• Change heart rate

  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

Study Arms (2)

Virtual Reality application group

EXPERIMENTAL

VR application will be applied to the experimental group during the emergency surgical intervention under local anesthesia.

Device: Virtual Reality Glasses

Control

NO INTERVENTION

The patients in the control group routinely receives standard care in the emergency service. No application will be made to the control group.

Interventions

Virtual Reality Glasses DEVICE

In addition to the routine practice of the emergency service, the virtual reality (VR) group will watch a video with VR glasses during the emergency surgical intervention under local anesthesia. Before the emergency surgery, the patients will be asked to wear a VR glasses compatible with mobile phones with android operating system and a headset that minimizes sound loss. Patients will be shown their preferred 3D licensed video software with relaxing music in the background. VR glasses will be put on the patients before starting the emergency surgical procedure under local anesthesia and applied until the procedure was completed. Patients will be asked to refill the The State Anxiety Inventory at the end of the emergency surgical intervention. At the same time, blood pressure, heart rate, respiratory rate, SpO2 values will be monitored on a portable monitor.

Virtual Reality application group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Turkey, Mersin University,

Mersin, Turkey (Türkiye)

Location

Related Publications (1)

• Gong M, Dong H, Tang Y, Huang W, Lu F. Effects of aromatherapy on anxiety: A meta-analysis of randomized controlled trials. J Affect Disord. 2020 Sep 1;274:1028-1040. doi: 10.1016/j.jad.2020.05.118. Epub 2020 May 26.

  PMID: 32663929 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Gülay Altun Ugras, Doctorate

  Mersin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Model Details: prospective, parallel, two arm, randomized controlled clinical trial

Study Record Dates

• First Submitted: February 6, 2022
• First Posted: February 23, 2022
• Study Start: February 20, 2022
• Primary Completion: February 20, 2022
• Study Completion: March 24, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)