Menstrual Health Education for Visually Impaired Adolescent

NCT06490016 | Not Yet Recruiting

• 2 other identifiers: 04.02.2023/83223K208
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned as a two-group randomized controlled interventional study to determine the effect of face-to-face and web-based menstrual health education given to visually impaired adolescent girls on menstrual attitude, menstrual symptoms and anxiety.

Conditions

Visual Impairment; Menstrual Problem

Keywords

anxiety; health education; nurse; menstruation; visually impaired adolescent

Outcome Measures

Primary Outcomes (3)

• Primary Outcome Measure 1

  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. 1. Menstruation as a debilitating phenomenon, 2. Menstruation as a disturbing phenomenon, 3. Menstruation as a natural phenomenon, 4. Noticing/anticipating that menstruation will occur 5. Deny the effects of menstruation. The scale is Likert type and evaluated between 1-7. The reliability coefficient of the original scale is 0.95-0.97. A high average of the scores obtained from the items, subgroups or the entire scale in the Menstruation Attitude Scale indicates that the attitude towards menstruation is "positive". As the scores of the scale increase, the positive attitude towards menstruation increases. At the same time, it is planned to increase the scale score by providing planned training.

  during 6 week

• Primary Outcome Measure 2

  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

  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

Study Arms (2)

Intervention group that given face to face education

EXPERIMENTAL

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.

Behavioral: Face to face

Intervention group that given web-based education

EXPERIMENTAL

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.

Device: web based education

Interventions

web based education DEVICE

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. 1. st meeting: online "Informed Consent" will be obtained. After the meeting, the Personal Information Form, Menstrual Attitude Scale, Menstrual Symptom Scale, State and Trait Anxiety Scale will be filled out online. 2. nd interview: Module 1-2. 3. rd interview: Module 3 -4. 4. th meeting: Module 5.They will be asked to fill out the System Usability Scale. 5. th interview: During the first menstrual period after the training, the Menstrual Attitude Scale, Menstrual Symptom Scale, and State Anxiety Scale will be completed online. 6. th interview: During the second menstrual period after the training, the Menstrual Attitude Scale, Menstrual Symptom Scale, and State Anxiety Scale will be completed online.

Intervention group that given web-based education

Face to face BEHAVIORAL

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. 1. st interview: "Informed Consent" . After the meeting, the Personal Information Form, Menstrual Attitude Scale, Menstrual Symptom Scale, State and Trait Anxiety Scale will be filled out. 2. nd meeting: Module 1-2 3. rd meeting: Module 3- 4 4. th meeting: Module 5. 5. th interview: Menstrual Attitude Scale, Menstrual Symptom Scale, State Anxiety Scale will be completed. 6. th interview: Menstrual Attitude Scale, Menstrual Symptom Scale, State Anxiety Scale will be completed.

Intervention group that given face to face education

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Not attending face-to-face or web-based training for at least 1 week.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Çukurova University

Adana, Sarıçam, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vision Disorders; Menstruation Disturbances; Anxiety Disorders; Health Education

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Mental Disorders; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Evşen Nazik, PhD,RN

  Cukurova University

  STUDY DIRECTOR

Central Study Contacts

Hatice GÜDÜL ÖZ, MSc, RN

CONTACT

05075104883; haticegudul@gmail.com

Evşen NAZİK, PhD,RN

CONTACT

05054525263; eceevsen_61@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: There are 2 groups: 2 interventional group

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: July 8, 2024
• Study Start: October 20, 2024
• Primary Completion: February 25, 2025
• Study Completion: February 15, 2026
• Last Updated: July 8, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)