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

NCT07016932 | Enrolling By Invitation

• 2 other identifiers: 2024/288323S198
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Mother; Menstrual Hygiene Management; Hand Hygiene; Intellectual Disability, Mild

Keywords

mild intellectual disability; adolescent; mother; menstruation management; hand hygiene

Outcome Measures

Primary Outcomes (1)

• Introductory Form for Mothers and Female Adolescents with Intellectual Disabilities

  This form was developed through a literature review to be used in both "analysis" and "design" phases of the study. The form consists of two sections to determine the socio-demographic characteristics of mothers and daughters and the menstrual characteristics of the mentally disabled female adolescent. In the first part of the form in which socio-demographic characteristics were evaluated, there were 17 questions such as the age of the mother and daughter, education and employment status of the mother, while in the second part of the form in which menstrual characteristics of the mentally disabled female adolescent were evaluated, there were 11 questions about menstruation period and hygiene such as whether menarche started or not, whether menstrual cycle was regular or not, whether the mother gave education to her daughter about menstrual period and pad change or not.

  1st Time: Day 1

Secondary Outcomes (1)

• Hand Hygiene Skill Performance Recording Chart

  1st Time: Day 1, 2nd Time: Day 30, 3rd Time: Day 90, 4th Time: Day 240

Other Outcomes (5)

• Menstrual Care (Using Pads) Skill Performance Record Chart

  1st Time: Day 1, 2nd Time: Day 30, 3rd Time: Day 90, 4th Time: Day 240

• Mobile Application Usability Scale

  1st Time: Day 240

• Mobile Application Willingness to Use Scale

  1st Time: Day 240

Study Arms (2)

Mobile application group

EXPERIMENTAL

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

Behavioral: Education with mobile application

Control group

NO INTERVENTION

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.

Interventions

Education with mobile application 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)

Mobile application group

Eligibility Criteria

• Age: 10 Years - 19 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selçuklu Özel Eğitim Meslek Okulu

Konya, Selçuklu, 42250, Turkey (Türkiye)

Location

Related Publications (4)

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

  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.

  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 .

  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.

  RESULT

Related Links

• link to the mobile app

MeSH Terms

Conditions

Intellectual Disability; Lymphoma, Follicular

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Alan Dikmen, Assoc. Prof.

  Selcuk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assos. Prof.

Model Details: 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

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 12, 2025
• Study Start: April 9, 2025
• Primary Completion: December 9, 2025
• Study Completion: January 30, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)