Examining the Effect of Virtual Reality on Pain and Anxiety Management During Pelvic Examination

Study Overview
=================
Brief Summary
-----------------
Objective: The study was conducted as a randomized controlled experimental study to examine the effect of the video watched with virtual reality glasses during the pelvic examination on the level of pain and anxiety perceived by women. Materials-Methods: The sample of the study consisted of 128 women (64 experimental, 64 control group) who applied to the Obstetrics and Gynecology Polyclinics with non-pregnancy complaints between November 2021 and February 2022, volunteered to participate in the study and were approved by the doctor for pelvic examination. Institutional and ethical committee permissions were obtained before starting the study. Descriptive Information Form, State Anxiety Scale, Visual Comparison Scale (GDS), Pelvic Examination Experience Evaluation Questionnaire, and Questionnaire Evaluating Non-Verbal Responses to Emotional Stressful Situations, prepared by the researcher, were used to collect data. In the pre-test to the women in the experimental group of the study: Descriptive Information Form, State Anxiety Scale, Visual Comparison Scale (for anxiety), then Pelvic examination + Virtual reality application (using virtual reality glasses for a minimum of 5 maximum 15 minutes), Emotional Stress to be applied by the researcher The Form Evaluating Non-Verbal Responses to the Creating Situations, and in the post-test: State Anxiety Scale, Visual Comparison Scale (anxiety + pain), Pelvic Examination Experience Evaluation Questionnaire were applied. In the pre-test to the women in the control group of the study: Introductory Information Form, State Anxiety Scale, Visual Comparison Scale (for anxiety), then Pelvic examination (routine service), Form Evaluating Non-Verbal Responses to Emotional Stressing Situations to be administered by the Researcher, In the post-test: State Anxiety Scale, Visual Comparison Scale (anxiety + pain), Pelvic Examination Experience Evaluation Questionnaire were applied. Data were evaluated in computer environment and using SPSS 23.0 statistical package program. A p value of <.05 for the data was considered statistically significant.

Official Title
-----------------
Examining the Effect of Virtual Reality on Pain and Anxiety Management During Pelvic Examination

Conditions
-----------------
Pelvic Examination,Virtual Reality

Intervention / Treatment
-----------------
* Device: Virtual reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being between the ages of 18-40 Being able to read and write To be competent to express oneself Having applied to the outpatient clinic for any gynecological complaint (bleeding, menstrual cycle irregularity, discharge, itching...) or for routine gynecological control. Exclusion Criteria: Having a current pregnancy Complaining of acute pelvic pain Having any damage or lesion in the perineum that may cause pain during the examination Having used a pharmacological agent or method with analgesic or anxiolytic effect 24 hours before the examination Having a vaginismus problem Having any physical or mental problems that may prevent communication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Before preparing for pelvic training, information was given about virtual training applications, 1-2 minutes of practical information about both virtual glasses and pelvic training. Afterwards, the woman was taken to the gynecological examination table and, as the doctor began the examination, virtual glasses were put on the woman and a virtual reality application containing both sound and image was performed for 5-15 minutes. In the meantime, the pelvic examination was performed by the physician, the researcher accompanied the woman at all stages of the pelvic examination process and provided care based on ethical principles, which cared for the woman, respected, protected privacy. | Device: Virtual reality<br>* I had the women wear virtual reality glasses and watch the video they wanted for at least 5, maximum 15 minutes during the examination.<br>|
| No Intervention: Control group<br>The control group was accompanied by the woman at all stages of the pelvic examination process, and the care service that cared for the woman, was respectful, privacy was protected and based on ethical principles was given in the same way, but the virtual glasses initiative was not applied. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level | The visual comparison scale,(VAS).The visual analog scale has a score from 1 to 10. The higher the score, the higher the pain intensity. | 15 minutes | 
| Anxiety level | The visual comparison scale and the state anxiety scale were evaluated.(VAS).The visual analog scale has a score from 1 to 10. The higher the score, the higher the pain intensity. State Anxiety Scale(STAI FORM TX - I) It is an inventory in which state anxiety is evaluated. The scores vary between 20 and 80 points. With the increase in the score, the level of anxiety also increases. | 15 minutes | 
| Pelvic examination using virtual reality glasses | Before the video, anxiety is evaluated with a visual comparison scale, then videos with nature, rain, water, flower scenes are watched for 5 to 15 minutes by wearing virtual reality glasses. Afterwards, anxiety and pain are evaluated with state anxiety scale and visual comparison scale. All results SPSS 23.0 It is analyzed by the program. | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic Exam, Pain, Anxiety, Virtual Reality