Gynecological ExaminationNCT07599358
The Impact of AI-Powered Training on Gynecological Examination Anxiety and Satisfaction
A study testing AI-assisted education in people with Gynecological Examination and Artificial Intelligence (AI), run by Fenerbahce University.
Trial summary
Gynecological cancers, particularly cervical, ovarian, and endometrial cancers, pose a global problem. Cervical cancers are quite common worldwide, and this rate is even higher in developing countries. Cervical cancers are easily treatable when detected early, and screening is quite easy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecological Examination, Artificial Intelligence (AI), Patient Satisfaction
- What is being tested?
- AI-assisted education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2026to 29 Sep 2026
- Phase
- Interventional
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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Applying to the outpatient clinic for a gynecological examination
- Being between 18-65 years of age
- Agreeing to participate in the study
Who cannot join
- Communication barrier
- Having a psychological diagnosis,
- Being pregnant
About this study
Official title: Digital Transformation in Women's Health: The Impact of AI-Powered Training on Gynecological Examination Anxiety and Satisfaction
Gynecological cancers, particularly cervical, ovarian, and endometrial cancers, pose a global problem. Cervical cancers are quite common worldwide, and this rate is even higher in developing countries. Cervical cancers are easily treatable when detected early, and screening is quite easy. Diagnosis is routinely made through human papillomavirus (HPV) testing and cytological screening. Eliminating anxiety, fear, and uncertainty about gynecological examinations makes the examination process easier, thus enabling early diagnosis and treatment of diseases. Keeping up with developing and changing technology and using it to improve women's health is an undeniable change in recent times. This study aims to determine the effect of an AI-assisted informational training program on women's anxiety and satisfaction levels regarding gynecological examinations.
- Being tested
- AI-assisted education
- Keywords
- gynecological examination, artificial intelligence, patient satisfaction, anxiety
- Medical subject headings
- Patient Satisfaction, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-assisted educationBehavioural
As an initiative, ChatGPT, one of the most commonly used artificial intelligence tools, was asked to prepare a text to provide women with detailed information before gynecological examinations. This text was evaluated by three gynecologists specializing in the field, and necessary adjustments were made. Based on this text, ChatGPT was asked to generate visuals for the relevant text. Using these visuals, a 4.13-minute video was created via Canva to inform patients before their gynecological examinations. Subtitles were added to the video, considering the potential noise level. Women randomly assigned to the intervention group will be shown the video before their examinations.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | Groups that will receive AI-assisted training before gynecological examinations. Receives: Behavioral: AI-assisted education |
| control group | No intervention | group that will not be intervened with |
What is being measured
The primary outcome is the main question the study is designed to answer.
Women's anxiety levels
This study aims to investigate the effect of an AI-assisted training intervention on women's anxiety levels during gynecological examinations. The Gynecological Examination Anxiety Scale will be administered before and after the gynecological examination. The scale consists of 20 items and is divided into 5 sub-dimensions: healthcare personnel approach, healthcare personnel experience, negative experiences, hygienic reasons, and individual attitudes. The Cronbach's Alpha coefficient of the scale was determined to be 0.867 (Demirtop, 2014).While there are no items that are reverse-scored on the scale, a high score indicates high anxiety.
Measured: through study completion, an average of 1 hour.
Women's satisfaction level
The Outpatient Patient Satisfaction Scale, developed by Kevenk, Kantas-Yilmaz, and Ozturk, consists of 26 items and 4 dimensions: examination, diagnosis and treatment process, physical environment, appointment process, and communication. The Cronbach's Alpha coefficient of the scale was determined to be 0.947 (Kevenk, Kantas-Yilmaz, and Ozturk, 2021). An increase in the score obtained from the scale indicates increased satisfaction.
Measured: through study completion, an average of 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start2 May 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion29 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological ExaminationStudies 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
- Participant
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Gül Bursa, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599358
- Sponsor's protocol ID
- Fenerbahce Uni
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No