Menstrual Management Using a Mobile Application in Adolescent Girls With Mild Intellectual Disabilities

NCT ID: NCT07016932

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-09

Study Completion Date

2026-01-30

Brief Summary

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In the study conducted to determine the effectiveness of menstruation management training given with a mobile application (Bağımsız Yapabilirim) in female adolescents with mild intellectual disabilities in the independent living support program, the effect of the developed mobile application on hand hygiene and pad change will be determined. The research is a randomized controlled study.

Detailed Description

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When the existing literature is examined, it is seen that there are limited number of studies on menstruation management education. In the studies, menstrual hygiene education was given to mentally disabled adolescent girls in small groups with model dolls or videos on social media that were not prepared by experts. Although these studies show that menstrual hygiene education given to mentally disabled students is successful, they are limited to small sample groups. For adolescent girls with intellectual disabilities, the onset of menstruation affects their independence and creates additional concerns for mothers at home, at school and in other settings. In studies conducted with mothers of adolescent girls with intellectual disabilities, mothers reported that they worried about their daughters' inability to understand menstruation, inability to change pads or dispose of them in the trash can appropriately, inability to pay attention to privacy during these special days, and that they did not send their daughters to school because they thought that they could not manage the menstruation process. Mothers' worries and fears during this process cause adolescent girls with intellectual disabilities to spend approximately one week at home every month, preventing them from socializing, negatively affecting their academic skills, further slowing their developmental processes and making it difficult for them to get used to independent life. In addition, studies show that the quality of life of both mothers and girls decreases significantly due to poor management of the menstruation process.

The main aim of this study was to determine the effectiveness of menstruation management training given to female adolescents with mild intellectual disabilities using a mobile application (Bağımsız Yapabilirim).

Conditions

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Mother Menstrual Hygiene Management Hand Hygiene Intellectual Disability, Mild

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

After randomization, female adolescents with mild intellectual disabilities will be trained with the mobile application (I Can Do It Independently) in addition to routine education. The mobile application will be introduced to the mothers of the female adolescents and installed on their phones. Then, the mothers will be asked to create a "user name and password" and will be registered to the mobile education application. In the meantime, the mothers will be told again how to use the mobile training application. I can do it independently was developed by the researchers. During the mobile application development process, suggestions were received from experts and the mobile application was finalized. Mild female adolescents in the experimental group were required to watch hand hygiene and menstruation management videos on the mobile application every day and play the games that followed. The researcher will call the mothers twice a week to inquire about their mobile application usage. T
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The mild female adolescents in the experimental group are required to log in to the mobile application every day, watch the hand hygiene and menstruation management videos, and play the games that follow. The mothers will be called twice a week by the researcher to ask about their mobile application usage. Therefore, researcher blinding will not be performed. The data for the study is collected by an interviewer.

In the study, a single blinding method in which the participants are blinded will be used. In order to prevent detection bias, data collection forms will be collected by the interviewer who has no knowledge about the research groups. In order to prevent reporting bias, the data obtained from the research will be coded as A and B by an independent researcher and transferred to the SPSS programme, and the analysis of the data coded in terms of groups will be carried out by an independent statistical expert.

Study Groups

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Mobile application group

After randomization, female adolescents with mild intellectual disabilities will be trained with the mobile application (I Can Do It Independently) in addition to routine education. The mobile application will be introduced to the mothers of the girl adolescents and installed on their phones. Then, the mothers will be asked to create a "user name and password" and will be registered to the mobile education application. In the meantime, the mothers will be told again how to use the mobile education application. I Can Do It Independently was developed by the researchers. During the mobile application development process, suggestions were received from experts and the mobile application was finalized. Mild level female adolescents in the experimental group were required to enter the mobile application every day, watch hand hygiene and menstruation management videos and play the games that followed. Mothers will be called twice a week by the researcher and their mobile application usage

Group Type EXPERIMENTAL

Education with mobile application

Intervention Type BEHAVIORAL

The "I Can Do It Independently" mobile application developed by the researchers includes two training videos on hand hygiene and menstruation management. Adolescents will be asked to play the games related to the training after watching the training videos. Thus, it is aimed for the participant to reinforce the training. The mobile application was developed by a multidisciplinary team of special education, nurse, midwife and software engineering academicians specifically for female adolescents with mild intellectual disabilities. Adolescents in the intervention group will be asked to use the mobile application for approximately 30 minutes every day. (https://play.google.com/store/apps/details?id=com.hookey.bagimsizyapabilirim\&pcampaignid=web\_share)

Control group

The routine education program will be applied to the mildly mentally retarded female adolescents assigned to the control group, and after the data are collected, the mothers and female adolescents in the control group will also be trained by the researchers with the mobile application.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education with mobile application

The "I Can Do It Independently" mobile application developed by the researchers includes two training videos on hand hygiene and menstruation management. Adolescents will be asked to play the games related to the training after watching the training videos. Thus, it is aimed for the participant to reinforce the training. The mobile application was developed by a multidisciplinary team of special education, nurse, midwife and software engineering academicians specifically for female adolescents with mild intellectual disabilities. Adolescents in the intervention group will be asked to use the mobile application for approximately 30 minutes every day. (https://play.google.com/store/apps/details?id=com.hookey.bagimsizyapabilirim\&pcampaignid=web\_share)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with mild intellectual disability
* Menstrual cycle has started and menstruation is regular
* Primary caregivers are mothers
* Toilet-trained
* Has the ability to stick an adhesive object to a surface and remove it from the surface
* Have the ability to dress and undress
* Have the ability to follow simple instructions
* Adolescent girls and their mothers who have the ability to recognize the materials to be used will be included in the study.

Exclusion Criteria

* Not willing to use the mobile application at any stage of the study
* Participated in a different training on menstruation management while the research was ongoing
* Not completing the education process
* Not completing the data collection forms
* Mentally disabled adolescent girls with moderate, severe and very severe intellectual disabilities and their mothers will be excluded from the study.
Minimum Eligible Age

10 Years

Maximum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Hacer ALAN DİKMEN

Assos. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alan Dikmen, Assoc. Prof.

Role: STUDY_DIRECTOR

Selcuk University

Locations

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Selçuklu Özel Eğitim Meslek Okulu

Konya, Selçuklu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Güler, Ç. 2019. "A structural equation model to examine mobile application usability and use." Bilişim Teknolojileri Dergisi, 12(3), 169-181.

Reference Type RESULT

Genç, Z., Masalimova, A., Platonova, R., Sizova, Z., Popova, O. 2019. "Analysis of documents published in scopus database on special education learning through mobile learning: A content analysis". International Journal of Emerging Technologies in Learning (IJET), 14(22), 192-203.

Reference Type RESULT

Bakır, D., Demirli, C. 2020. "Investigation of the impact of self-compassion and family support perception on parenting stress in parents who have children with learning disability, autism spectrum disorder and mental disability". Humanistic Perspective, 2 (3), 271-282 .

Reference Type RESULT

Açar, D., Dilbilir, Y., Demiralp, C. 2022. "Özel eğitim öğretmenlerinin zihinsel yetersizliği olan çocukların eğitimi sürecindeki görüşlerinin incelenmesi". Abant İzzet Baysal Üniversitesi Eğitim Fakültesi Dergisi, 22(3), 1295-1312.

Reference Type RESULT

Related Links

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Other Identifiers

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323S198

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024/288

Identifier Type: -

Identifier Source: org_study_id

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