NCT06241885

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

September 25, 2024

Status Verified

August 1, 2024

Enrollment Period

1 month

First QC Date

January 28, 2024

Last Update Submit

September 23, 2024

Conditions

AnxietyPainSatisfaction

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Intervention group I

EXPERIMENTAL

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.

Behavioral: Intervention group I

Control

NO INTERVENTION

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.

Interventions

Intervention group IBEHAVIORAL

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 group I

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Literate,
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPainPersonal Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

January 28, 2024

First Posted

February 5, 2024

Study Start

November 15, 2024

Primary Completion

December 15, 2024

Study Completion

June 15, 2025

Last Updated

September 25, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)