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

Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06241885
• Other study ID #: First Vaginal Examination
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: December 15, 2024

Study information

• Verified date: January 2024
• Source: Kahramanmaras Sutcu Imam University
• Contact: Deniz Akyildiz
• Phone: 905069851358
• Email: denizbatman[@]ksu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain
• Satisfaction

Intervention

Procedure:
• Intervention group I
The women in this group will be covered with a gynaecological drape on the gynaecological table by the same researcher before vaginal examination. This cover will be prepared as disposable, terikoton fabric and 80x200 cm in size.
• Intervention group II
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety	Anxiety levels of women related to vaginal examination will be measured using The Trait Anxiety Inventory Form in intervention I, II, and control group.	10 minutes before and 10 minutes after vaginal examination
Primary	Pain level	Pain levels of women related to vaginal examination will be measured using VAS Pain Scale in intervention I, II, and control group.	10 minutes before and 10 minutes after vaginal examination
Primary	Satisfaction level	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.	10 minutes after vaginal examination