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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07016932
Acronym
Independent
Enrollment
82
Registered
2025-06-12
Start date
2025-04-09
Completion date
2026-01-30
Last updated
2025-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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).

Interventions

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)

Sponsors

Selcuk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

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

Eligibility

Sex/Gender
FEMALE
Age
10 Years to 19 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Introductory Form for Mothers and Female Adolescents with Intellectual Disabilities1st Time: Day 1This 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.

Secondary

MeasureTime frameDescription
Hand Hygiene Skill Performance Recording Chart1st Time: Day 1, 2nd Time: Day 30, 3rd Time: Day 90, 4th Time: Day 240This form was created according to the hand washing guide of the Ministry of Health to be used in the implementation phase of the study according to the ADDIE learning design model and in the experimental and control groups in the final phase of the study. The form includes 10 statements created in accordance with the hand hygiene steps in order to measure the hand hygiene skills of female adolescents.

Other

MeasureTime frameDescription
Mobile Application Willingness to Use Scale1st Time: Day 240To measure the willingness to use a mobile application by users. The scale, which consists of a single factor and 6 items, ranges from 1 to 7 (1: Strongly Disagree, 2: Disagree, 3: Somewhat Disagree, 4: Undecided, 5: Somewhat Agree, 6: Agree, 7: Strongly Agree) Likert-type scale. There are no items that need to be reverse coded in the scale.
Mobile Application Usage Loyalty Scale1st Time: Day 240To determine users' usage loyalty for a mobile application. The scale, which consists of a single factor and 5 items, ranges from 1 to 7 (1: Strongly Disagree, 2: Disagree, 3: Somewhat Disagree, 4: Undecided, 5: Somewhat Agree, 6: Agree, 7: Strongly Agree). There are no items that need to be reverse coded.
Visual Analog Scale (VAS)-Satisfaction1st Time: Day 240VAS- satisfaction is a 10 cm long instrument. On the left end of the scale, 0=not satisfied at all and 10=very satisfied on the right end. A high score on the scale indicates a high level of satisfaction with menstruation management education, while a score of 0 indicates no satisfaction with menstruation management education.
Mobile Application Usability Scale1st Time: Day 240The Mobile Application Usability Scale was developed to evaluate the usability of a mobile application. It is a scale consisting of 10 factors with 4 items in each factor and 40 items in total. The scale ranges from 1 to 7 (1: Strongly Disagree, 2: Disagree, 3: Somewhat Disagree, 4: Undecided, 5: Somewhat Agree, 6: Agree, 7: Strongly Agree). There are no items that need to be reverse coded.
Menstrual Care (Using Pads) Skill Performance Record Chart1st Time: Day 1, 2nd Time: Day 30, 3rd Time: Day 90, 4th Time: Day 240This form was created through a literature review to be used in the implementation phase of the study according to the ADDIE learning design model and in the experimental and control groups in the final phase of the study. The form includes 17 statements created in accordance with the steps of changing pads in order to measure the menstrual care (pad change) skills of female adolescents. This form will be filled out by the mothers of female adolescents with intellectual disabilities four times in total: before the application, at the end of the first, third and eighth month after the girl started using the mobile application.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026