- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07599358
The Impact of AI-Powered Training on Gynecological Examination Anxiety and Satisfaction
May 14, 2026 updated by: Ayşe Gül Bursa, Fenerbahce University
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
114
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Applying to the outpatient clinic for a gynecological examination
- Being between 18-65 years of age
- Agreeing to participate in the study
Exclusion Criteria:
- Communication barrier
- Having a psychological diagnosis,
- Being pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: intervention group
Groups that will receive AI-assisted training before gynecological examinations.
|
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.
|
|
No Intervention: control group
group that will not be intervened with
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Women's anxiety levels
Time Frame: through study completion, an average of 1 hour.
|
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.
|
through study completion, an average of 1 hour.
|
|
Women's satisfaction level
Time Frame: through study completion, an average of 1 hour.
|
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.
|
through study completion, an average of 1 hour.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 2, 2026
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
September 29, 2026
Study Registration Dates
First Submitted
April 29, 2026
First Submitted That Met QC Criteria
May 14, 2026
First Posted (Actual)
May 20, 2026
Study Record Updates
Last Update Posted (Actual)
May 20, 2026
Last Update Submitted That Met QC Criteria
May 14, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fenerbahce Uni
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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