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NCT Number: NCT06241885

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

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

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Personal Satisfaction Satisfaction Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

Location contact

Deniz Akyıldız

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention group I

Behavioral

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 length for women.

Primary outcomes

  1. Anxiety

    Time frame: 10 minutes before and 10 minutes after vaginal examination

    Anxiety levels of women related to vaginal examination will be measured using The Trait Anxiety Inventory Form in intervention I, II, and control group.

  2. Pain level

    Time frame: 10 minutes before and 10 minutes after vaginal examination

    Pain levels of women related to vaginal examination will be measured using VAS Pain Scale in intervention I, II, and control group.

  3. Satisfaction level

    Time frame: 10 minutes after vaginal examination

    It will be used to assess women's satisfaction with vaginal examination. In this scale, women will be asked to indicate the level of satisfaction from 1 to 5.

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 5, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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