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Artificial IntelligenceNCT07598929

AI-Based Education and Menstrual Health Behaviors in Adolescents

A study testing AI-Supported Mobile Education, Face-to-Face Education and Brochure-Based Education in people with Artificial Intelligence and Self-care, run by Cumhuriyet University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is designed as a randomized controlled trial aiming to compare the effectiveness of different educational approaches in improving dysmenorrhea self-care and genital hygiene behaviors among adolescent girls. Read more about this study

Who is it for?
Ages 14 to 17 years, women onlyHealthy volunteers can take part
Conditions the study is for
Artificial Intelligence, Self-care, Dysmenorrhea
What is being tested?
AI-Supported Mobile Education, Face-to-Face Education and Brochure-Based Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Apr 2026to 19 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 14 to 17 years
  • Women only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Being aged 14-17 years
  • Having experienced menarche (having an active menstrual cycle)
  • Having experienced dysmenorrhea at least once within the past six months
  • Being a high school student and having the cognitive ability to understand the educational materials
  • Having access to a smartphone and the internet (mandatory for the AI group; preferred for comparability across groups)
  • Willingness to participate in the study voluntarily
  • Provision of parental/legal guardian consent due to being under 18 years of age

Who cannot join

  • Having a diagnosed chronic gynecological condition (e.g., endometriosis)
  • Regular use of medications that may affect the menstrual cycle
  • Having previously received structured menstrual health education (to minimize confounding effects)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hacı Mehmet Sabancı Anatolian High School

    Merkez, Sivas, 58010

Other trials in Turkey (Türkiye)

About this study

Official title: Effectiveness of Artificial Intelligence Supported Mobile Education Compared With Face-to-Face and Brochure-Based Education on Dysmenorrhea Self-Care and Genital Hygiene Behaviors in Adolescent Girls: A Randomized Controlled Trial

This study is designed as a randomized controlled trial aiming to compare the effectiveness of different educational approaches in improving dysmenorrhea self-care and genital hygiene behaviors among adolescent girls. Participants will be allocated into three groups: an artificial intelligence-supported mobile education group, a face-to-face education group, and a brochure-based control group. The intervention process will be conducted using a pretest-posttest design, with assessments performed at baseline, 4 weeks after baseline, and 8 weeks after baseline. In the artificial intelligence-supported mobile education group, participants will receive individualized and interactive content, while the same content will be delivered directly by the researcher in the face-to-face education group, and written informational materials will be provided to the control group. Valid and reliable instruments assessing dysmenorrhea self-care behaviors and genital hygiene practices will be used for data collection. The findings are expected to provide evidence on the effectiveness of digital health interventions in adolescent health and contribute to the development of nursing practices and health education programs.

Being tested
AI-Supported Mobile Education, Face-to-Face Education, Brochure-Based Education
Keywords
Adolescent girls, Artificial intelligence, Dysmenorrhea, Genital hygiene, Self-care behaviors, Health education, Nursing
Medical subject headings
Dysmenorrhea, Health Education

What participants receive

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

  • AI-Supported Mobile EducationBehavioural

    Participants will receive artificial intelligence-supported personalized mobile education aimed at improving dysmenorrhea self-care and genital hygiene behaviors. Before the education, participants will complete a pretest including the Sociodemographic Characteristics and Menstruation Information Form, the Genital Hygiene Behaviors Scale, and the Adolescent Dysmenorrhea Self-Care Scale. Educational content will be delivered in a personalized manner through a ChatGPT-based system. The initial education session will be administered at baseline, followed by a reinforcement session 2 weeks after baseline. The educational content will include menstruation knowledge, methods for coping with menstrual pain, healthy genital hygiene behaviors, help-seeking behaviors, and safe self-care practices. Participants will be re-evaluated using the Genital Hygiene Behaviors Scale and the Adolescent Dysmenorrhea Self-Care Scale at 4 weeks and 8 weeks after baseline.

  • Face-to-Face EducationBehavioural

    Participants will receive face-to-face education delivered by an expert educator aimed at improving dysmenorrhea self-care and genital hygiene behaviors. Before the education, participants will complete a pretest including the Sociodemographic Characteristics and Menstruation Information Form, the Genital Hygiene Behaviors Scale, and the Adolescent Dysmenorrhea Self-Care Scale. The educational content will be delivered face-to-face by the researcher using standardized educational materials. The initial education session will be administered at baseline, followed by a reinforcement session 2 weeks after baseline. The educational content will include menstruation knowledge, methods for coping with menstrual pain, healthy genital hygiene behaviors, help-seeking behaviors, and safe self-care practices. Participants will be re-evaluated using the Genital Hygiene Behaviors Scale and the Adolescent Dysmenorrhea Self-Care Scale at 4 weeks and 8 weeks after baseline.

  • Brochure-Based EducationBehavioural

    Participants will receive an informational brochure aimed at improving dysmenorrhea self-care and genital hygiene behaviors. During the first meeting, participants will complete a pretest including the Sociodemographic Characteristics and Menstruation Information Form, the Genital Hygiene Behaviors Scale, and the Adolescent Dysmenorrhea Self-Care Scale. Afterwards, the same standardized informational brochure will be provided to all participants. The brochure content will include menstruation knowledge, methods for coping with menstrual pain, healthy genital hygiene behaviors, help-seeking behaviors, and safe self-care practices. Participants will be re-evaluated using the Genital Hygiene Behaviors Scale and the Adolescent Dysmenorrhea Self-Care Scale at 4 weeks and 8 weeks after baseline.

Study groups in NCT07598929
Study groupRoleWhat they receive
AI-Supported Mobile Education GroupExperimentalNot described
Receives: Behavioral: AI-Supported Mobile Education
Face-to-Face Education GroupExperimentalNot described
Receives: Behavioral: Face-to-Face Education
Brochure-Based Control GroupActive comparatorNot described
Receives: Behavioral: Brochure-Based Education

What is being measured

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

  1. Dysmenorrhea Self-Care Behavior Scale Total Score

    Dysmenorrhea self-care behaviors assessed using the Dysmenorrhea Self-Care Behavior Scale. The Dysmenorrhea Self-Care Scale was developed by Hsieh et al. (2004), and its Turkish adaptation was conducted by Sürücü and Ergün (2023). The scale is used to evaluate adolescent girls' self-care experiences related to dysmenorrhea. It consists of 40 items rated on a 6-point Likert-type scale (0 = strongly disagree, 1 = 20% agree, 2 = 40% agree, 3 = 60% agree, 4 = 80% agree, 5 = 100% agree). The scale includes six subdimensions: information seeking (items 1-4), expression of emotions (items 5-10), seeking help (items 11-14), control of external factors (items 15-21), coping practices (items 22-35), and self-control (items 36-40). The total score ranges from 0 to 200. Higher scores indicate better dysmenorrhea self-care behaviors. The Cronbach's alpha reliability coefficients for the overall scale and subdimensions ranged between 0.62 and 0.89.

    Measured: At baseline, 4 weeks after baseline, and 8 weeks after baseline

  2. Genital Hygiene Behavior Scale Total Score

    Genital hygiene behaviors assessed using the Genital Hygiene Behavior Scale. The Genital Hygiene Behaviors Scale was developed by Karahan (2017), and the Cronbach's Alpha internal consistency coefficient was reported as 0.80. The scale is a five-point Likert-type instrument (1 = Strongly disagree, 5 = Strongly agree) used to evaluate individuals' genital hygiene behaviors. The scale consists of 23 items and includes three subdimensions: "General Hygiene Habits" (items 1-12), "Menstrual Hygiene" (items 13-20), and "Awareness of Abnormal Findings" (items 21-23). Items 7, 14, 19, 20, and 23 are reverse scored. The total score ranges from 23 to 115. Higher scores indicate more positive and adequate genital hygiene behaviors.

    Measured: At baseline, 4 weeks after baseline, and 8 weeks after baseline

Timeline

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

  1. First posted20 May 2026
  2. Study start20 Apr 2026
  3. Primary completion20 May 2026 (estimated)
  4. Study completion19 Jun 2026 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
AI-Supported Mobile Education Group Face-to-Face Education Group Brochure-Based Control Group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07598929
Sponsor's protocol ID
2025-09/43
Status last verified
May 2026
First submitted
5 May 2026
Last updated
20 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vural, P. I., & Çiftçi, F. (2021). Menstrual Practice Needs Scale (MPNS): Reliability and validity of the Turkish version. Cyprus Journal of Medical Sciences, 6(4), 295-303. https://doi.org/10.5152/cjms.2021-166-232

  • Trepanier LCM, Lamoureux E, Bjornson SE, Mackie C, Alberts NM, Gagnon MM. Smartphone apps for menstrual pain and symptom management: A scoping review. Internet Interv. 2023 Jan 30;31:100605. doi: 10.1016/j.invent.2023.100605. eCollection 2023 Mar.

    PubMed 36761398
  • Sürücü, E., & Ergün, A. (2023). The Turkish Validity and Reliability of The Adolescent Dysmenorrhea Self-Care Scale. Clinical and Experimental Health Sciences, 13(2), 299-307. https://doi.org/10.33808/clinexphealthsci.983007

  • Rahman MJ, Rahman MM, Sarker MHR, Ahmed A, Ali M, Islam MZ, Bubly JA, Hawlader DH, Shimpuku Y. The Impact of mHealth Education on Changing Menstrual Hygiene Management Knowledge and Practices Among School-Going Adolescent Girls in Rural Bangladesh: A Quasi-experimental Study Protocol. Cureus. 2024 Jan 12;16(1):e52157. doi: 10.7759/cureus.52157. eCollection 2024 Jan.

    PubMed 38344509
  • Karahan, N. (2017). Genital Hijyen Davranışları Ölçeğinin geliştirilmesi: Geçerlik güvenirlik çalışması. Istanbul Medical Journal, 18(3),157-162.

  • Cunningham AC, Prentice C, Peven K, Wickham A, Bamford R, Radovic T, Klepchukova A, Fomina M, Cunningham K, Hill S, Hantsoo L, Payne J, Zhaunova L, Ponzo S. Efficacy of the Flo App in Improving Health Literacy, Menstrual and General Health, and Well-Being in Women: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 May 2;12:e54124. doi: 10.2196/54124.

    PubMed 38696773
  • Balamurugan SS, Bendigeri N. Community-based study of reproductive tract infections among women of the reproductive age group in the urban health training centre area in hubli, karnataka. Indian J Community Med. 2012 Jan;37(1):34-8. doi: 10.4103/0970-0218.94020.

    PubMed 22529538
  • Armour M, Parry K, Al-Dabbas MA, Curry C, Holmes K, MacMillan F, Ferfolja T, Smith CA. Self-care strategies and sources of knowledge on menstruation in 12,526 young women with dysmenorrhea: A systematic review and meta-analysis. PLoS One. 2019 Jul 24;14(7):e0220103. doi: 10.1371/journal.pone.0220103. eCollection 2019.

    PubMed 31339951

Questions about this trial

What is this clinical trial studying?

A study testing AI-Supported Mobile Education, Face-to-Face Education and Brochure-Based Education in people with Artificial Intelligence and Self-care, run by Cumhuriyet 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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. 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?

This study is still under way. Results are not available in the source record yet.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dysmenorrhea Self-Care Behavior Scale Total Score (time frame: At baseline, 4 weeks after baseline, and 8 weeks after baseline). The study lists 2 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 NCT07598929, which also lists 8 linked publications.

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 20 May 2026.

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