NCT07599358

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started May 2026

Shorter than P25 for not_applicable

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

Study Progress14%
May 2026Sep 2026

First Submitted

Initial submission to the registry

April 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 2, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2026

Last Updated

May 20, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 29, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

gynecological examinationartificial intelligencepatient satisfactionanxiety

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    through study completion, an average of 1 hour.

Study Arms (2)

intervention group

ACTIVE COMPARATOR

Groups that will receive AI-assisted training before gynecological examinations.

Behavioral: AI-assisted education

control group

NO INTERVENTION

group that will not be intervened with

Interventions

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.

intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince this is a study on gynecological examinations for women, only women can participate in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Applying to the outpatient clinic for a gynecological examination
  • Being between 18-65 years of age
  • Agreeing to participate in the study

You may not qualify if:

  • Communication barrier
  • Having a psychological diagnosis,
  • Being pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patient SatisfactionAnxiety Disorders

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 20, 2026

Study Start

May 2, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

September 29, 2026

Last Updated

May 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share