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Not yet recruiting NCT06241885

Anxiety, Pain, and Satisfaction Related to First Vaginal Examination in Women

No phase Interventional Anxiety Pain Satisfaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention group I.
Who it may be relevant to
Registry conditions: Anxiety, Pain, Satisfaction. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effect of Gynaecological Drape and Specially Developed Gynaecological Shorts on Anxiety, Pain, and Satisfaction Related to First Vaginal Examination in Women: a Randomised Controlled Study

Overview

The Effect of Gynaecological Drape and Specially Developed Gynaecological Shorts on Anxiety, Pain and Satisfaction Related to First Vaginal Examination in Women: A Randomised Controlled Study

Detailed description

Many women feel anxiety and pain about gynecological examination. The aim of the study was to investigate the effect of gynaecological drape and specially developed gynaecological shorts used for the first time in vaginal examination on anxiety, pain and satisfaction related to examination.

Interventions

  • Behavioral Intervention group I
    Women in Intervention Group II will wear gynaecological shorts specially developed by the researchers before vaginal examination. These shorts will be made of disposable fabric and will be sewn by the researchers in four different sizes (S-M-L-XL) according to the weight of the women. The middle part of the shorts will be closed with a snap button, and the opening will be provided when the snap button is opened during vaginal examination. In addition, these shorts will be approximately knee-cap

Primary outcome measures

  • Anxiety [Time frame: 10 minutes before and 10 minutes after vaginal examination]
  • Pain level [Time frame: 10 minutes before and 10 minutes after vaginal examination]
  • Satisfaction level [Time frame: 10 minutes after vaginal examination]

Eligibility criteria

Inclusion criteria

  • Literate,
  • 18 years of age or older,
  • Can speak and understand Turkish,
  • You are a woman who is having a vaginal examination for the first time
  • Women who volunteered to participate in the study

Exclusion criteria

  • Physical or mental illness that prevents them from communicating,
  • Vaginal examination by a health professional other than the designated gynaecologist,
  • Those who answered the research questions incompletely and
  • Women who want to withdraw from the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Kahramanmaras Sutcu Imam University — Kahramanmaraş

Identifiers

NCT: NCT06241885 · First Vaginal Examination

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗