Clinical trial NCT05545488: Examining the Effect of Virtual Reality on Pain and Anxiety Management During Pelvic Examination
Official title: Examining the Effect of Virtual Reality on Pain and Anxiety Management During Pelvic Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Examination,Virtual Reality
Keywords: Pelvic Exam
Pain
Anxiety
Virtual Reality
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Pain level
timeFrame: 15 minutes
measure: Anxiety level
timeFrame: 15 minutes
measure: Pelvic examination using virtual reality glasses
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa
Study officials:
References:
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