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临床试验/NCT07016932
NCT07016932Enrolling By Invitation不适用

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

Selcuk University1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年4月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
82
试验地点
1
主要终点
Introductory Form for Mothers and Female Adolescents with Intellectual Disabilities

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
10 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

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

干预措施: Education with mobile application (Behavioral)

结局指标

主要结局

Introductory Form for Mothers and Female Adolescents with Intellectual Disabilities

时间窗: 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.

次要结局

  • Hand Hygiene Skill Performance Recording Chart(1st Time: Day 1, 2nd Time: Day 30, 3rd Time: Day 90, 4th Time: Day 240)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hacer ALAN DİKMEN

Assos. Prof.

Selcuk University

研究点 (1)

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