Anxiety, Pain, and Satisfaction Related to First Vaginal Examination in Women
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKahramanmaras Sutcu Imam University
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention group I
BehavioralWomen 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Intervention group IExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
10 minutes before and 10 minutes after vaginal examination2
Pain level
Pain levels of women related to vaginal examination will be measured using VAS Pain Scale in intervention I, II, and control group.
Time frame
10 minutes before and 10 minutes after vaginal examination3
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.
Time frame
10 minutes after vaginal examinationSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: