MotherIndependentNCT07016932
Menstrual Management Using a Mobile Application in Adolescent Girls With Mild Intellectual Disabilities
A study testing Education with mobile application in people with Mother and Menstrual Hygiene Management, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mother, Menstrual Hygiene Management, Hand Hygiene
- What is being tested?
- Education with mobile application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Apr 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Selçuklu Özel Eğitim Meslek Okulu
Konya, Selçuklu, 42250
About this study
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
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.
Read the 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).
- Being tested
- Education with mobile application
- Keywords
- mild intellectual disability, adolescent, mother, menstruation management, hand hygiene
- Medical subject headings
- Intellectual Disability, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education with mobile applicationBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st Time: Day 1
Secondary outcomes (1)
Hand Hygiene Skill Performance Recording Chart
This 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.
Measured: 1st Time: Day 1, 2nd Time: Day 30, 3rd Time: Day 90, 4th Time: Day 240
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start9 Apr 2025
- Primary completion9 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MotherStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer ALAN DİKMEN, Selcuk University
- Investigators
- Alan Dikmen, Assoc. Prof., Study director, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016932
- Sponsor's protocol ID
- 2024/288
- Other IDs
- 323S198
- Acronym
- Independent
- Status last verified
- Jun 2025
- First submitted
- 15 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Güler, Ç. 2019. "A structural equation model to examine mobile application usability and use." Bilişim Teknolojileri Dergisi, 12(3), 169-181.
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.
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 .
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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07016932
- Acronym / sponsor ID
- Independent / 2024/288
- Keywords
- mild intellectual disability, adolescent, mother, menstruation management, hand hygiene
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 9 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Mobile application group | Experimental | Behavioral: Education with mobile applicationAfter 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 |
| 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. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education with mobile applicationThe "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) | Behavioural | Mobile application group |
Primary outcome
Introductory Form for Mothers and Female Adolescents with Intellectual Disabilities
Time frame: 1st Time: Day 1
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.
1 secondary outcome
Hand Hygiene Skill Performance Recording Chart
Time frame: 1st Time: Day 1, 2nd Time: Day 30, 3rd Time: Day 90, 4th Time: Day 240
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Results publicationGüler, Ç. 2019. "A structural equation model to examine mobile application usability and use." Bilişim Teknolojileri Dergisi, 12(3), 169-181.
- Results publicationGenç, 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.
- Results publicationBakır, 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 .
- Results publicationAçar, 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.
- Individual participant dataSharing planned: No
Related trials for Mother
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
Active, not recruiting
Investigating Baby Behavior and Family Technology Use Study
Mobile Phone Use, Mother-Infant Interaction
Not yet recruiting
Postpartum Care in the NICU Multi-Site Breastfeeding
Postpartum Complication, Postpartum
Not yet recruiting
Effects of Maternal and Infant Massage on Breastfeeding and Mother-Infant Bonding
Breastfeeding, Mother-Infant Bonding
Recruiting
Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression
Low Birth Weight, Kangaroo Mother Care
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alan Dikmen, Assoc. Prof. study director
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education with mobile application in people with Mother and Menstrual Hygiene Management, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Form for Mothers and Female Adolescents with Intellectual Disabilities (time frame: 1st Time: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07016932, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025; AzTrials last refreshed its copy on 3 Nov 2026.