Skip to main content
OpenTrials
Completed

NCT Number: NCT05545488

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Virtual reality

Device

I had the women wear virtual reality glasses and watch the video they wanted for at least 5, maximum 15 minutes during the examination.

Primary outcomes

  1. Pain level

    Time frame: 15 minutes

    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.

  2. Anxiety level

    Time frame: 15 minutes

    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.

  3. Pelvic examination using virtual reality glasses

    Time frame: 15 minutes

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2022
Registry last updated
Sep 19, 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.

Published trials that share one or more normalized conditions with this study.