- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06490016
Menstrual Health Education for Visually Impaired Adolescent
Effect of Web Based Menstrual Health Education on Menstrual Attitude, Menstrual Symptoms and Anxiety Among Visually Impaired Adolescent
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Menstruation is a physiological and natural process of the reproductive system. It is reported that more than 300 million individuals menstruate every day worldwide. On average, a woman menstruates for approximately 3,000 days, or 8 years, between the ages of 11 and 49. Therefore, menstruation is an important issue that requires physical, spiritual and social adaptation for women. It is known that the majority of menstruating individuals have serious problems in managing their monthly menstrual cycles healthily and effectively. However, the menstrual needs of girls and women with different types of disabilities vary compared to individuals without disabilities.
Since the sense of sight has an important place in performing daily activities, visually impaired girls and women are one of the disabled groups that experience various difficulties during the menstrual process. In the literature, it is seen that visually impaired individuals have negative myths and beliefs about the menstrual period, have difficulties with self-care, do not comply with hygiene rules during the menstrual period, and talk about menstrual hygiene management with their mothers, sisters, friends, etc. It is emphasized that there are deficiencies in their knowledge and practices regarding menstrual hygiene, that they see the menstrual period as a shame, and that they experience difficulties such as social isolation and forced sterilization. In this context, the menstrual period emerges as an important global public health problem for visually impaired girls and women.
Menstrual health/hygiene management is important in order to cope with the problems experienced during menstruation. United Nations International Children's Emergency Fund underlines that menstrual health and hygiene management should be addressed within a broader framework, reconciling health, well-being, gender equality, education, social equality, individual empowerment policies and human rights. The only point that distinguishes visually impaired women from sighted women regarding menstruation is menstrual hygiene management. Menstrual management in visually impaired women; It varies depending on the use of materials such as pads and tampons, hygiene training, degree of social support, disability status of the person and symptoms related to menstruation. Different methods and tools can be used in training for visually impaired individuals. When providing education to visually impaired individuals, changes should be made in the tools used rather than the content of the education. Because lack of vision does not constitute an obstacle to their education. Training can be provided using models, printed brochures containing the Braille alphabet, voice recordings and assistive technologies.
The comprehensive menstrual hygiene management training to be prepared will guide health professionals, special education teachers and institutions. Studies have reported that nurses have difficulty and experience communication problems while providing care to disabled individuals. It is believed that it will guide nurses regarding the educational methods and needs of visually impaired individuals. In addition, it is a study that can support healthcare personnel who may be inadequate in consultancy and training roles due to the insufficient number of healthcare personnel in our country and their high workload. In particular, the widespread use of web-based training in the education of disabled individuals can be an opportunity for many disabled individuals who have economic, transportation and material problems, regardless of time and place.
Hypotheses of the research:
Ho: Between groups; Ho1: There is no difference between menstrual attitude scale scores in web-based and face-to-face menstrual health education.
Ho2: There is no difference between menstrual symptom scale scores in web-based and face-to-face menstrual health education.
Ho3: There is no difference between anxiety scores in web-based and face-to-face menstrual health education.
H1: Between groups:
H11: There is a difference between menstrual attitude scale scores in web-based and face-to-face menstrual health education.
H12: There is a difference between menstrual symptom scale scores in web-based and face-to-face menstrual health education.
H13: There is a difference between anxiety scores in web-based and face-to-face menstrual health education.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hatice Güdül Öz, MSc, RN
- Phone Number: 05075104883
- Email: haticegudul@gmail.com
Study Contact Backup
- Name: Evşen NAZİK, PhD,RN
- Phone Number: 05054525263
- Email: eceevsen_61@hotmail.com
Study Locations
-
-
Sarıçam
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Adana, Sarıçam, Turkey, 01330
- Çukurova University
-
Contact:
- Hatice Güdül Öz, MSc, RN
- Phone Number: 05075104883
- Email: haticegudul@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
For face-to-face education:
- Be between the ages of 11-19
- Ability to read and write
- Menstruation
- Having at least 60% vision loss (those with congenital or acquired vision loss)
For web-based training:
- Be between the ages of 11-19
- Ability to read and write
- Menstruation
- Having at least 60% vision loss (those with congenital or acquired vision loss)
- Having a computer or mobile phone compatible with a screen reader program and internet access.
Exclusion Criteria:
• Not attending face-to-face or web-based training for at least 1 week.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group that given face to face education
6 face-to-face meetings will be held with adolescent disabled girls.
Training will be held collectively at school or in an association.
The training modules will last 3 weeks and 5 modules will be used in the training.
(1st Meeting and Survey collection, 2nd week: 1st and 2nd module, 3rd week: 3 modules and 4th week: 5 modules, 6th interview: after training).
Training modules will be given every week at a determined place and time.
Following the training, the effect of the training will be investigated by repeating the data collection forms twice at 1-month intervals during the menstrual periods of the participants.
|
In face-to-face training, "female internal reproductive organ models", "female external reproductive organ models", "training content prepared with Braille alphabet", "menstrual hygiene management kit (underwear, pads, napkins, calendar)" materials will be used. Pictures and audio descriptions will be used in web-based training.
|
|
Experimental: Intervention group that given web-based education
This group will not be met face to face and communication will be provided via the website.
A username and password will be defined for each user before entering the web page.
Visually impaired adolescent girls will be able to individually enter the relevant modules without assistance, read the module they want, and listen to the depicted pictures and graphics.
From the admin section of the website, it will be tracked who attended the training, how many minutes they stayed, and how many times a week they attended.
The training modules will last 3 weeks and 5 modules will be used in the training.
(1st Meeting and Survey collection, 2nd week: 1st and 2nd module, 3rd week: 3 modules and 4th week: 5 modules, 6th interview: after training).
A reminder notification will be sent to the contact section on the website every week for them to attend the training.
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The web page will be prepared with professional support in line with the guidelines of the Web Content Accessibility Guide (WCAG / WIEK 2.1) developed by W3C.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary Outcome Measure 1
Time Frame: during 6 week
|
Menstrual Attitude Scale will be used to score the menstrual attitude level. The scale consists of 33 items. MBI consists of five subscales that question the positive and negative aspects of menstruation.
At the same time, it is planned to increase the scale score by providing planned training. |
during 6 week
|
|
Primary Outcome Measure 2
Time Frame: during 6 week
|
The Menstrual Symptom Scale will be used to score menstrual symptom level. The Menstruation Symptom Scale evaluates menstrual pain and symptoms. Participants are asked to give a number between 1 (never) and 5 (always) to the symptoms they experience regarding menstruation. 1-13. Items belong to the "Negative effects/somatic complaints" subscale, items 14-19. The items refer to the "Menstrual pain symptoms" subscale and items 20-22. The items belong to the "Coping methods" sub-dimension. Cronbach's Alpha value is 0.86. It is a five-point Likert type scale consisting of 22 items. The score obtained from the sub-dimensions is calculated by taking the total score average of the items in the sub-dimensions. An increase in the mean score for sub-dimensions indicates that the severity of menstrual symptoms related to that sub-dimension has increased. At the same time, it is planned to reduce the scale score by providing planned training. |
during 6 week
|
|
Primary Outcome Measure 3
Time Frame: during 6 week
|
State and Trait Anxiety Scale will be used to score the state and trait anxiety level. Each expression in the scale is "Not at all" (1), "Somewhat" (2), "A lot" (3), "Completely" (4). It indicates that 0-19 points obtained from the scale mean no anxiety, 20-39 points mean mild anxiety, 40-59 points mean moderate anxiety, and 60-79 points mean severe anxiety, and individuals with scores of 60 and above need professional help. At the same time, it is planned to reduce the scale score by providing planned training. |
during 6 week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Evşen Nazik, PhD,RN, Çukurova University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04.02.2023/83
- 223K208 (Other Grant/Funding Number: TUBITAK 1001)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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