- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07598929
AI-Based Education and Menstrual Health Behaviors in Adolescents
14. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
120
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Sivas
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Merkez, Sivas, Tyrkia (Türkiye), 58010
- Hacı Mehmet Sabancı Anatolian High School
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Ja
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: AI-Supported Mobile Education Group
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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.
|
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Eksperimentell: 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.
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Aktiv komparator: Brochure-Based Control Group
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Dysmenorrhea Self-Care Behavior Scale Total Score
Tidsramme: At baseline, 4 weeks after baseline, and 8 weeks after baseline
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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.
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At baseline, 4 weeks after baseline, and 8 weeks after baseline
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Genital Hygiene Behavior Scale Total Score
Tidsramme: At baseline, 4 weeks after baseline, and 8 weeks after baseline
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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.
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At baseline, 4 weeks after baseline, and 8 weeks after baseline
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. april 2026
Primær fullføring (Antatt)
20. mai 2026
Studiet fullført (Antatt)
19. juni 2026
Datoer for studieregistrering
Først innsendt
5. mai 2026
Først innsendt som oppfylte QC-kriteriene
14. mai 2026
Først lagt ut (Faktiske)
20. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Smerte
- Nevrologiske manifestasjoner
- Patologiske prosesser
- Bekkensmerter
- Menstruasjonsforstyrrelser
- Patologiske tilstander, tegn og symptomer
- Oppførsel
- Tegn og symptomer
- Behandlingsoverholdelse og etterlevelse
- Helseatferd
- Pasientens etterlevelse
- Pasientens aksept av helsehjelp
- Adherence -intervensjoner
- Medisinoverholdelse
- Dysmenoré
- Helse utdanning
Andre studie-ID-numre
- 2025-09/43
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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