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NCT Number: NCT05253274

The Effect of Virtual Reality Glasses Applied During Emergency Surgical Intervention

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turkey, Mersin University,

Mersin, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Anxiety evaluated using the State Anxiety Scale

    Time frame: Change from baseline and ten minutes

    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 outcomes

  1. Change systolic blood pressure

    Time frame: During emergency surgery with Local Anesthesia

    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).

  2. Change diastolic blood pressure

    Time frame: During emergency surgery with Local Anesthesia

    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).

  3. Change heart rate

    Time frame: During emergency surgery with Local Anesthesia

    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).

  4. Change respiratory rate

    Time frame: During emergency surgery with Local Anesthesia

    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).

  5. Change peripheral oxygen saturation

    Time frame: During emergency surgery with Local Anesthesia

    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).

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

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

Acronym: Virtual

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2022
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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