AnxietyNCT06241885

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

A study testing Intervention group I in people with Anxiety and Pain, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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 Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Anxiety, Pain, Satisfaction
What is being tested?: Intervention group I
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Nov 2024to 15 Jun 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Kahramanmaras Sutcu Imam University
Kahramanmaraş
Deniz Akyıldız, denizbtm@gmail.com

Other trials in Turkey (Türkiye)

About this study

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

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

Read the 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.

Conditions: Anxiety, Pain, Satisfaction
Being tested: Intervention group I
Medical subject headings: Anxiety Disorders, Pain, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intervention group IBehavioural
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.

Study groups in NCT06241885
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 10 minutes after vaginal examination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 202415 Jun 2025

First posted5 Feb 2024
Study start15 Nov 2024 (estimated)
Primary completion15 Dec 2024 (estimated)
Study completion15 Jun 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnxietyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06241885
Sponsor's protocol ID: First Vaginal Examination
Status last verified: Aug 2024
First submitted: 28 Jan 2024
Last updated: 25 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06241885
Acronym / sponsor ID: First Vaginal Examination
Conditions: Anxiety, Pain, Satisfaction
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 120 participants (estimated)
Lead sponsor: Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
Study start: 15 Nov 2024 (estimated)
Primary completion: 15 Dec 2024 (estimated)
Study completion: 15 Jun 2025 (estimated)
First posted: 5 Feb 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention group I	Experimental	Behavioral: Intervention group IWomen 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.
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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intervention group IWomen 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.	Behavioural	Intervention group I

Primary outcome

Anxiety
Time frame: 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.
Pain level
Time frame: 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.
Satisfaction level
Time frame: 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.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

denizbtm@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intervention group I in people with Anxiety and Pain, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety (time frame: 10 minutes before and 10 minutes after vaginal examination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06241885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.