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

Not Applicable

Not yet recruiting

• Conditions: Pain; Anxiety; Satisfaction
• Interventions: Behavioral: Intervention group I

• Registration Number: NCT06241885
• Lead Sponsor: Kahramanmaras Sutcu Imam University

Brief Summary

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-28
• Study First Submitted QC: 2024-01-28
• Last Update Submitted: 2024-01-28
• Study First Posted: 2024-02-05
• Last Update Posted: 2024-02-05
• Study Start: 2024-03-15
• Primary Completion: 2024-07-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group I	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.

Primary Outcome Measures

Name	Time	Method
Anxiety	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.
Satisfaction level	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.
Pain level	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.

Trial Locations

Locations (1)

Kahramanmaras Sutcu Imam University; 🇹🇷 Kahramanmaraş, Turkey