- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07598929
AI-Based Education and Menstrual Health Behaviors in Adolescents
May 14, 2026 updated by: Nermin Altunbaş, Cumhuriyet University
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sivas
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Merkez, Sivas, Turkey (Türkiye), 58010
- Hacı Mehmet Sabancı Anatolian High School
-
-
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
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AI-Supported Mobile Education Group
|
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.
|
|
Experimental: Face-to-Face Education Group
|
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.
|
|
Active Comparator: Brochure-Based Control Group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dysmenorrhea Self-Care Behavior Scale Total Score
Time Frame: At baseline, 4 weeks after baseline, and 8 weeks after baseline
|
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.
|
At baseline, 4 weeks after baseline, and 8 weeks after baseline
|
|
Genital Hygiene Behavior Scale Total Score
Time Frame: At baseline, 4 weeks after baseline, and 8 weeks after baseline
|
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.
|
At baseline, 4 weeks after baseline, and 8 weeks after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
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 (Actual)
April 20, 2026
Primary Completion (Estimated)
May 20, 2026
Study Completion (Estimated)
June 19, 2026
Study Registration Dates
First Submitted
May 5, 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
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Pathologic Processes
- Pelvic Pain
- Menstruation Disturbances
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Treatment Adherence and Compliance
- Health Behavior
- Patient Compliance
- Patient Acceptance of Health Care
- Adherence Interventions
- Medication Adherence
- Dysmenorrhea
- Health Education
Other Study ID Numbers
- 2025-09/43
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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