Vaginal Examination Drape Supporting Women's Privacy

Overview

This single-blind, parallel-group randomised controlled trial evaluates whether a vaginal examination drape designed to support women's privacy reduces pain and improves perceived privacy and examination satisfaction during gynaecological vaginal examination. Women aged 18 and over undergoing vaginal examination at a gynaecology and obstetrics outpatient clinic are randomly allocated 1:1 to an intervention group, in which the privacy-supporting drape is used, or a control group receiving the clinic's routine examination practice. Immediately after the examination, pain (Visual Analogue Scale), examination satisfaction (Gynecologic Examination Satisfaction Scale) and perceived body privacy (Body Privacy in Gynaecology and Obstetrics Scale) are assessed.

Background: Gynaecological and vaginal examinations are core services for protecting and promoting women's sexual and reproductive health and for the early detection of disease. Often described as the most intimate of examinations, the gynaecological assessment is usually performed in the lithotomy position and is frequently experienced as uncomfortable, embarrassing and highly stressful. Being fully exposed and inadequately covered is a major source of anxiety and can lead women to avoid or postpone gynaecological screening. Protecting body privacy is an indispensable part of respectful gynaecological care and is directly related to self-esteem, trust in the health professional and overall satisfaction. Unmet privacy expectations increase state anxiety, which raises muscle tension, reduces examination comfort and intensifies the perception of pain. Standard drapes and gowns leave the genital area exposed for examination while failing to fully protect the privacy of other areas. Intervention: A specially designed vaginal examination drape that covers the lower extremities, the pelvic region and the non-examined parts of the body, allowing only the anatomical area to be assessed to be exposed during the procedure by means of a hook-and-loop opening. The drape aims to minimise unnecessary body exposure, help the woman feel in control, encourage muscle relaxation and thereby reduce pain perception and increase examination satisfaction. Design: Parallel-group, single-blind, randomised controlled trial reported according to the CONSORT 2025 statement. Participants are allocated 1:1 to the intervention or control group using block randomisation (block size 4, 25 blocks) generated by an independent statistician and concealed in opaque, sealed, sequentially numbered envelopes. Because the drape is visible to participants and providers, participant and provider blinding is not possible; blinding is applied at the data-entry and analysis stages, so the trial is single blind (outcome assessor and data analyst blinded). Hypotheses: H1: Women examined with the privacy-supporting drape have lower pain than the control group. H2: Women examined with the drape have higher perceived privacy than the control group. H3: Women examined with the drape have higher examination satisfaction than the control group. Sample size: Calculated with G\*Power 3.1.9.4 using an independent-samples t test comparing two group means, with an effect size of 0.60, alpha of 0.05 and power of 0.80 at a 1:1 allocation, giving a minimum of 90 women (45 per group). Increasing by 10 percent for possible data loss, 100 women (50 per group) are planned. Statistical analysis: Analyses are performed with SPSS 25.0. Group sociodemographic comparability is checked with the chi-square test. Between-group differences in scale scores are assessed with one-way ANOVA or the Kruskal-Wallis H test according to distribution, and mixed-design ANOVA with Bonferroni correction is used for comparisons across measurement times. Significance is set at p less than 0.05 with 95 percent confidence intervals. Ethics: Ethics approval will be obtained from the Non-Drug and Non-Medical Device Research Ethics Board of KTO Karatay University Faculty of Medicine, and institutional permission from the participating hospital, before the study begins. The trial is conducted in accordance with the Declaration of Helsinki, and written informed consent is obtained from all participants.