Clinical trial NCT07016932: Menstrual Management Using a Mobile Application in Adolescent Girls With Mild Intellectual Disabilities
Official title: Independent Life Support Program; Determination of the Effectiveness of Menstruation Management Training Given With Mobile Application (Independent I Can) in Female Adolescents With Mild Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Mother
Menstrual Hygiene Management
Hand Hygiene
Intellectual Disability, Mild
Keywords: mild intellectual disability
adolescent
mother
menstruation management
hand hygiene
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 82
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Introductory Form for Mothers and Female Adolescents with Intellectual Disabilities
timeFrame: 1st Time: Day 1
Secondary outcomes:
measure: Hand Hygiene Skill Performance Recording Chart
timeFrame: 1st Time: Day 1, 2nd Time: Day 30, 3rd Time: Day 90, 4th Time: Day 240
Other outcomes:
measure: Menstrual Care (Using Pads) Skill Performance Record Chart
timeFrame: 1st Time: Day 1, 2nd Time: Day 30, 3rd Time: Day 90, 4th Time: Day 240
measure: Mobile Application Usability Scale
timeFrame: 1st Time: Day 240
measure: Mobile Application Willingness to Use Scale
timeFrame: 1st Time: Day 240
measure: Mobile Application Usage Loyalty Scale
timeFrame: 1st Time: Day 240
measure: Visual Analog Scale (VAS)-Satisfaction
timeFrame: 1st Time: Day 240
Locations:
city: Konya
country: Turkey
facility: Selçuklu Özel Eğitim Meslek Okulu
state: Selçuklu
Study officials:
affiliation: Selcuk University
name: Alan Dikmen, Assoc. Prof.
role: STUDY_DIRECTOR
References:
citation: Güler, Ç. 2019. "A structural equation model to examine mobile application usability and use." Bilişim Teknolojileri Dergisi, 12(3), 169-181.
citation: 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.
citation: 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 .
citation: 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.