The Effect of Virtual Reality Glasses Applied During Emergency Surgical Intervention - Clinical Trial for Anxiety | NCT05253274

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Virtual Reality Glasses

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Anxiety, Virtual reality glasses, Emergency Surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Turkey, Mersin University,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality application group

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change systolic blood pressure

Determine patients physiological responses to anxiety (systolic blood pressure) before and after virtual reality application The researchers will measure the systolic blood pressure of the patients in the control group before and after emergency surgery with local anesthesia, and before and after the application to the experimental group after the virtual reality application. At the same time, systolic blood pressure values will be monitored on a portable monitor (8000c, Shenzhen Comen Medical Instruments Co., Ltd., China).

Change diastolic blood pressure

Determine patients' physiological responses to anxiety (diastolic blood pressure) before and after virtual reality application The researchers will measure the diastolic blood pressure of the patients in the control group before and after emergency surgery with local anesthesia, and before and after the application to the experimental group after the virtual reality application. At the same time, diastolic blood pressure values will be monitored on a portable monitor (8000c, Shenzhen Comen Medical Instruments Co., Ltd., China).

Change heart rate

Determine patients' physiological responses to anxiety (heart rate) before and after virtual reality application The researchers will measure heart rate of the patients in the control group before and after emergency surgery with local anesthesia, and before and after the application to the experimental group after the virtual reality application. At the same time, heart rate values will be monitored on a portable monitor (8000c, Shenzhen Comen Medical Instruments Co., Ltd., China).

Change respiratory rate

Determine patients' physiological responses to anxiety (respiratory rate) before and after virtual reality application The researchers will measure respiratory rate of the patients in the control group before and after emergency surgery with local anesthesia, and before and after the application to the experimental group after the virtual reality application. At the same time, respiratory rate values will be monitored on a portable monitor (8000c, Shenzhen Comen Medical Instruments Co., Ltd., China).

Change peripheral oxygen saturation

Determine patients' physiological responses to anxiety (peripheral oxygen saturation) before and after virtual reality application The researchers will measure peripheral oxygen saturation of the patients in the control group before and after emergency surgery with local anesthesia, and before and after the application to the experimental group after the virtual reality application. At the same time, peripheral oxygen saturation values will be monitored on a portable monitor (8000c, Shenzhen Comen Medical Instruments Co., Ltd., China).

Full Information

NCT ID

NCT05253274

First Posted

February 6, 2022

Last Updated

April 6, 2022

Sponsor

Mersin University

1. Study Identification

Unique Protocol Identification Number

NCT05253274

Brief Title

The Effect of Virtual Reality Glasses Applied During Emergency Surgical Intervention

Acronym

Virtual

Official Title

The Effect of Virtual Reality Glasses Applied During Emergency Surgical Intervention With Local Anesthesia on Patients Anxiety

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

February 20, 2022 (Actual)

Primary Completion Date

February 20, 2022 (Actual)

Study Completion Date

March 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mersin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety

Keywords

Anxiety, Virtual reality glasses, Emergency Surgery

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

prospective, parallel, two arm, randomized controlled clinical trial

Masking

None (Open Label)

Masking Description

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.

Allocation

Randomized

Enrollment

138 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Virtual Reality application group

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Virtual Reality Glasses

Intervention Description

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.

Primary Outcome Measure Information:

Title

Anxiety evaluated using the State Anxiety Scale

Description

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.

Time Frame

Change from baseline and ten minutes

Secondary Outcome Measure Information:

Title

Change systolic blood pressure

Description

Determine patients physiological responses to anxiety (systolic blood pressure) before and after virtual reality application The researchers will measure the systolic blood pressure of the patients in the control group before and after emergency surgery with local anesthesia, and before and after the application to the experimental group after the virtual reality application. At the same time, systolic blood pressure values will be monitored on a portable monitor (8000c, Shenzhen Comen Medical Instruments Co., Ltd., China).

Time Frame