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

I

Istanbul University - Cerrahpasa (IUC)

Status

Completed

Conditions

Pelvic Examination,Virtual Reality

Treatments

Device: Virtual reality

Study type

Interventional

Funder types

Other

Identifiers

NCT05545488
2021/20

Details and patient eligibility

About

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.

Enrollment

128 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

128 participants in 2 patient groups

Experimental group
Experimental group
Description:
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.
Treatment:
Device: Virtual reality
Control group
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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