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NCT Number: NCT07016932

Menstrual Management Using a Mobile Application in Adolescent Girls 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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Hand Hygiene Skill Performance Recording Chart

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

    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.

Other outcomes

  1. Menstrual Care (Using Pads) Skill Performance Record Chart

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

    This 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.

  2. Mobile Application Usability Scale

    Time frame: 1st Time: Day 240

    The 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.

  3. Mobile Application Willingness to Use Scale

    Time frame: 1st Time: Day 240

    To 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.

  4. Mobile Application Usage Loyalty Scale

    Time frame: 1st Time: Day 240

    To 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.

  5. Visual Analog Scale (VAS)-Satisfaction

    Time frame: 1st Time: Day 240

    VAS- 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.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study 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

Acronym: Independent

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 12, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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