Vaginal Examination Drape Supporting Women's Privacy

Sponsor
KTO Karatay University
Study ID
NCT07797309
Status
Enrolling By Invitation

Conditions

  • Gynecologic Examination
  • Pain
  • Patient Satisfaction
  • Privacy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Privacy-supporting vaginal examination drape — DEVICE
    A specially designed drape used during vaginal examination that covers the lower extremities, pelvic region and non-examined body parts, with a hook-and-loop opening that exposes only the anatomical area being examined, applied during the examination to minimise body exposure and support privacy.

Study Details

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.

Key Dates

First listed
Sep 1, 2026
Start date
Aug 26, 2026
Status verified
Aug 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Privacy-supporting drape group
    Women undergoing vaginal examination with the privacy-supporting vaginal examination drape, which covers the lower extremities, pelvis and non-examined body parts and exposes only the anatomical area being assessed via a hook-and-loop opening.
  • No Intervention: Control group (routine practice)
    Women undergoing vaginal examination with the clinic's routine examination practice, without the privacy-supporting drape.

Primary Outcome Measure

Pain during vaginal examination (Visual Analogue Scale, VAS) [ Time Frame: Immediately after the vaginal examination (Day 1) ]

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