Clinical trial NCT05253274: The Effect of Virtual Reality Glasses Applied During Emergency Surgical Intervention
Official title: The Effect of Virtual Reality Glasses Applied During Emergency Surgical Intervention With Local Anesthesia on Patients Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Virtual reality glasses
Emergency Surgery
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, parallel, two arm, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Anxiety evaluated using the State Anxiety Scale
timeFrame: Change from baseline and ten minutes
Secondary outcomes:
measure: Change systolic blood pressure
timeFrame: During emergency surgery with Local Anesthesia
measure: Change diastolic blood pressure
timeFrame: During emergency surgery with Local Anesthesia
measure: Change heart rate
timeFrame: During emergency surgery with Local Anesthesia
measure: Change respiratory rate
timeFrame: During emergency surgery with Local Anesthesia
measure: Change peripheral oxygen saturation
timeFrame: During emergency surgery with Local Anesthesia
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Turkey, Mersin University,
Study officials:
affiliation: Mersin University
name: Gülay Altun Ugras, Doctorate
role: STUDY_DIRECTOR
References:
citation: 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.