The Effect of a Vaginal Examination Drape Designed to Support Women's Privacy on Pain, Satisfaction and Perceived Privacy: A Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain during vaginal examination (Visual Analogue Scale, VAS)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Because the examination drape is visible to participants and providers, participant and provider blinding is not possible. To minimise bias, the outcome assessor / data-entry researcher and the statistician analysing the coded data are blinded to group allocation until analysis is complete (single-blind).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Undergoing vaginal examination
排除标准
- •Clinical condition requiring emergency obstetric or gynaecological intervention
- •A health problem preventing cognition or communication
- •Diagnosed psychological disorder (depression, post-traumatic stress disorder, bipolar disorder)
研究组 & 干预措施
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.
干预措施: Privacy-supporting vaginal examination drape (Device)
Control group (routine practice)
Women undergoing vaginal examination with the clinic's routine examination practice, without the privacy-supporting drape.
结局指标
主要结局
Pain during vaginal examination (Visual Analogue Scale, VAS)
时间窗: Immediately after the vaginal examination (Day 1)
Pain intensity measured on a 10 cm Visual Analogue Scale from 0 (no pain) to 10 (worst pain), completed immediately after the examination. Higher scores indicate greater pain.
Perceived body privacy (Body Privacy in Gynaecology and Obstetrics Scale)
时间窗: Immediately after the vaginal examination (Day 1)
Perceived privacy measured with the Body Privacy in Gynaecology and Obstetrics Scale (Degirmen and Sayligil, 2020), a 37-item, 5-point Likert scale with general privacy, rights and privacy, ethics and privacy, and clinical privacy subscales. Higher mean scores indicate greater sensitivity to and protection of privacy.
Gynaecological examination satisfaction (Gynecologic Examination Satisfaction Scale, GESS)
时间窗: Immediately after the vaginal examination (Day 1)
Satisfaction measured with the Gynecologic Examination Satisfaction Scale (Muslu, 2026), a 36-item, six-factor scale covering health personnel, examination environment, emotional reactions, menstruation-related concerns, hygiene and privacy. Higher scores indicate greater satisfaction with the gynaecological examination.
次要结局
未报告次要终点
研究者
Aslıhan Turan
Research Assistant, Midwifery
Osmaniye Korkut Ata University