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

NCT ID: NCT06241885

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2025-06-15

Brief Summary

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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

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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.

Conditions

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Anxiety Pain Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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 to be developed 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.

Group Type EXPERIMENTAL

Intervention group I

Intervention Type 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.

Control

The women in the control group will not be subjected to any additional hospital procedure during vaginal examination. Privacy curtains are routinely used in the hospital.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 length for women.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role lead

Responsible Party

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Deniz Akyıldız

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kahramanmaras Sutcu Imam University

Kahramanmaraş, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Facility Contacts

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Deniz Akyıldız

Role: primary

Other Identifiers

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First Vaginal Examination

Identifier Type: -

Identifier Source: org_study_id

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