Skip to content

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06241885
Enrollment
120
Registered
2024-02-05
Start date
2024-11-15
Completion date
2025-06-15
Last updated
2024-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pain, Satisfaction

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.

Interventions

BEHAVIORALIntervention 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.

Sponsors

Kahramanmaras Sutcu Imam University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Anxiety10 minutes before and 10 minutes after vaginal examinationAnxiety levels of women related to vaginal examination will be measured using The Trait Anxiety Inventory Form in intervention I, II, and control group.
Pain level10 minutes before and 10 minutes after vaginal examinationPain levels of women related to vaginal examination will be measured using VAS Pain Scale in intervention I, II, and control group.
Satisfaction level10 minutes after vaginal examinationIt 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026