The Effect of Virtual Reality Glasses Applied During Emergency Surgical Intervention

NCT ID: NCT05253274

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-20
• Study Completion Date: 2022-03-24

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.

Detailed Description

The sample of this study consisted of 138 patients in the experimental (n=69) and control groups (n=69). Virtual Reality (VR) application will be applied to the experimental group during the emergency surgical intervention under local anesthesia. Anxiety level will be assessed with the Spielberger State Anxiety Scale and measured by physiological responses of anxiety such as systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR) and peripheral oxygen saturation (SpO2) before and after VR application. In the control group, no application will be made except for standard care only.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Reality application group

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

Group Type: EXPERIMENTAL

Virtual Reality Glasses

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality Glasses

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Merve TOPAL

Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülay Altun Ugras, Doctorate

Role: STUDY_DIRECTOR

Mersin University

Locations

Turkey, Mersin University,

Mersin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 32663929 (View on PubMed)

Other Identifiers

MersinUn

Identifier Type: -

Identifier Source: org_study_id