Menstruation HygieneNCT07607171
Social Learning Theory-Based Menstruation Education in Visually Impaired Women
A study testing Theory-Based Menstrual and Hygiene Education Program in people with Menstruation Hygiene and Menstruation, run by Aylin Olgun at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of face-to-face practical training based on social learning theory on developing and changing skills and behaviors in providing genital and menstrual hygiene and improving menstrual self-care skills of visually impaired young women. Read more about this study
- Who is it for?
- Ages 15 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstruation Hygiene, Menstruation, Health Education
- What is being tested?
- Theory-Based Menstrual and Hygiene Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2024to 29 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female participants aged 15-30 years
- For totally blind participants: visual acuity of 20/200 or less in the better eye and/or a visual field of 20 degrees or less
- For low vision participants: visual acuity between 20/70 and 20/200 in the better eye
- Having experienced menstruation at least once
- No other disabilities, such as hearing or orthopedic impairments
- Voluntary participation with informed consent
Who cannot join
- Amenorrhea due to systemic or metabolic conditions (e.g., hypogonadotropic hypogonadism, hypothyroidism, hyperthyroidism, Turner syndrome)
- Visual conditions such as night blindness, color blindness, or monocular blindness that do not meet the defined visual impairment criteria
- Incomplete participation in the training or follow-up phases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Social Learning-Based Planned Education on Menstruation in Visually Impaired Young Women
The aim of this study is to evaluate the effect of face-to-face practical training based on social learning theory on developing and changing skills and behaviors in providing genital and menstrual hygiene and improving menstrual self-care skills of visually impaired young women.
Our hypotheses are:
Read more
H1: There is a difference between the mean Menstruation Symptom Questionnaire scores of the intervention group at the pre- and post-training follow-ups.
H2: There is a difference between the mean Genital Hygiene Behaviors Scale scores of the intervention group at the pre- and post-training follow-ups.
H3: There is a difference between the mean Menstruation Symptom Questionnaire scores of the intervention and control groups at the post-training follow-ups.
H4: There is a difference between the mean Genital Hygiene Behaviors Scale scores of the intervention and control groups at the post-training follow-ups.
H5: The mean Menstrual Self-Care Skill List scores of the intervention group after the training were higher than before the training. Researchers compared the knowledge and behavioral changes of the experimental and control groups after the training.
Participants did the following:They fully participated in the planned training, performed the skill applications, and answered the survey questions completely. They were expected to apply the knowledge and skills they learned in the training in their daily lives for 9 months. At the end of the 9th month, a follow-up interview was conducted, and an attitude assessment was performed.
- Conditions
- Menstruation Hygiene, Menstruation, Health Education, Self-care, Visually Impaired Persons, Nursing
- Being tested
- Theory-Based Menstrual and Hygiene Education Program
- Keywords
- Visually impaired persons, menstruation, hygiene, skill, nursing, health education
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theory-Based Menstrual and Hygiene Education ProgramBehavioural
This is a structured, face-to-face menstrual and hygiene education program based on Bandura's Social Learning Theory, developed for visually impaired young women. The intervention aims to improve menstrual self-care skills, genital hygiene behaviors, and symptom management. The training includes verbal instruction, modeling, reinforcement techniques, tactile materials, and audio-described educational videos. Interactive games and small-group activities (max 4 participants) are used to support engagement and skill development. Each session lasts approximately half a day (3-4 hours). Educational content was reviewed by experts and piloted for accessibility. The program addresses cognitive, behavioral, and sensory learning needs to support independent menstrual hygiene management in visually impaired women.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group received a structured, face-to-face, half-day education based on Bandura's Social Learning Theory. The training included verbal explanation, modeling, interactive games, tactile materials, and audio-described educational videos. The content focused on menstrual symptoms, genital hygiene behaviors, and menstrual self-care skills. Education was designed to be accessible for visually impaired participants. Receives: Behavioral: Theory-Based Menstrual and Hygiene Education Program |
| Control Group | No intervention | Participants in the control group did not receive any training. Only data collection was performed using the same forms and at the same time points as the intervention group. They were blinded to group allocation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstruation Symptom Questionnaire
Developed by Chesney and Tasto (1975) to assess menstrual pain and symptoms, the scale was updated by Negriff et al. (2009) by re-evaluating its factor structure and usability in adolescents. Turkish validity and reliability were established by Güvenç et al. (2014). The scale is a 5-point Likert-type scale consisting of 22 items. Participants are asked to rate their menstrual symptoms on a scale of 1 (never) to 5 (always). The scale consists of three sub-dimensions: Negative Effects/Somatic Complaints (Items 1-13), Menstrual Pain Symptoms (Items 14-19), and Coping Mechanisms (Items 20-22). The lowest possible score is 22, and the highest is 110. The average of the total scores obtained from the items on the scale provides the scale score. An increase in the average score indicates an increase in the severity of menstrual symptoms. The score obtained from the sub-dimensions of the scale is calculated by calculating the average total score of the item
Measured: Baseline and 9 months after intervention
Genital Hygiene Behavior Scale
Genital Hygiene Behavior Scale Developed by Karahan in 2017, this scale measures women's genital hygiene behaviors. It consists of three sub-dimensions: "General Hygiene " (12 items), "Menstrual Hygiene" (8 items), and " abnormal finding awareness" (3 items). The minimum scale score is 23, and the maximum is 115. The scale has 23 items, using a five-point Likert scale. Items are rated from "strongly agree = 5" to "strongly disagree = 1". As the score on the scale increases, the rate at which women exhibit correct genital hygiene behavior also increases. The Cronbach's alpha values for the scale are 0.80 for "Genital Hygiene Behaviors Scale", 0.70 for "Genital Hygiene Habits", 0.74 for "Menstrual Hygiene", and 0.8 for " abnormal finding awareness", respectively (Karahan, 2017).
Measured: Baseline and 9 months after intervention
Menstrual Self-Care Skills Checklist
The researcher prepared this skills checklist based on the literature. It consists of three sections: Menstruation Tracking Skills, Pad Changing Skills, and Genital Hygiene Skills. "No" is scored as "0", "Partially knowing" as "1", and "Yes" as "2". Expert evaluation was obtained to assess the content validity of the checklists.
Menstruation Tracking Skills; There are 7 items related to knowing the signs that menstruation, determine the day menstruation will begin, knowing the duration of menstrual bleeding, the frequency of menstruation, monitoring bleeding, and noticing pad fullness. The Pad Changing Skill consists of eight items in total. The steps are: removing the soiled pad from the underwear, removing and discarding the packaging of the clean pad, placing the clean pad into the underwear, and securing it to the underwear. Genital Hygiene Skills; This section includes seven items related to hand washing and genital cleaning.
Measured: Evaluated before and immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start2 Apr 2024
- Primary completion24 Feb 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstruation HygieneStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, parallel-group, single-blind, controlled trial with two arms: intervention and control. Participants were assigned using block randomization stratified by age group and level of visual impairment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aylin Olgun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aylin Olgun, Ege University
- Investigators
- Özlem Demirel Bozkurt, Associate Professor, PhD, RN, Principal investigator, Ege University Nursing Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607171
- Sponsor's protocol ID
- AYLINOLGUN_VISUALLYIMPAİRMENT
- Other IDs
- 125S056, 1219/1199
- Status last verified
- May 2026
- First submitted
- 12 Jul 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Social Learning-Based Planned Education on Menstruation in Visually Impaired Young Women
- ClinicalTrials.gov ID
- NCT07607171
- Acronym / sponsor ID
- AYLINOLGUN_VISUALLYIMPAİRMENT
- Conditions
- Menstruation Hygiene, Menstruation, Health Education, Self-care, Visually Impaired Persons, Nursing
- Keywords
- Visually impaired persons, menstruation, hygiene, skill, nursing, health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Aylin OlgunUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 26 May 2026 (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.
The aim of this study is to evaluate the effect of face-to-face practical training based on social learning theory on developing and changing skills and behaviors in providing genital and menstrual hygiene and improving menstrual self-care skills of visually impaired young women.
Our hypotheses are:
H1: There is a difference between the mean Menstruation Symptom Questionnaire scores of the intervention group at the pre- and post-training follow-ups.
H2: There is a difference between the mean Genital Hygiene Behaviors Scale scores of the intervention group at the pre- and post-training follow-ups.
H3: There is a difference between the mean Menstruation Symptom Questionnaire scores of the intervention and control groups at the post-training follow-ups.
H4: There is a difference between the mean Genital Hygiene Behaviors Scale scores of the intervention and control groups at the post-training follow-ups.
H5: The mean Menstrual Self-Care Skill List scores of the intervention group after the training were higher than before the training. Researchers compared the knowledge and behavioral changes of the experimental and control groups after the training.
Participants did the following:They fully participated in the planned training, performed the skill applications, and answered the survey questions completely. They were expected to apply the knowledge and skills they learned in the training in their daily lives for 9 months. At the end of the 9th month, a follow-up interview was conducted, and an attitude assessment was performed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized, parallel-group, single-blind, controlled trial with two arms: intervention and control. Participants were assigned using block randomization stratified by age group and level of visual impairment.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Theory-Based Menstrual and Hygiene Education ProgramParticipants in the intervention group received a structured, face-to-face, half-day education based on Bandura's Social Learning Theory. The training included verbal explanation, modeling, interactive games, tactile materials, and audio-described educational videos. The content focused on menstrual symptoms, genital hygiene behaviors, and menstrual self-care skills. Education was designed to be accessible for visually impaired participants. |
| Control Group | No intervention | –Participants in the control group did not receive any training. Only data collection was performed using the same forms and at the same time points as the intervention group. They were blinded to group allocation. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Female participants aged 15-30 years
- For totally blind participants: visual acuity of 20/200 or less in the better eye and/or a visual field of 20 degrees or less
- For low vision participants: visual acuity between 20/70 and 20/200 in the better eye
- Having experienced menstruation at least once
- No other disabilities, such as hearing or orthopedic impairments
Key exclusion criteria (3 listed)
- Amenorrhea due to systemic or metabolic conditions (e.g., hypogonadotropic hypogonadism, hypothyroidism, hyperthyroidism, Turner syndrome)
- Visual conditions such as night blindness, color blindness, or monocular blindness that do not meet the defined visual impairment criteria
- Incomplete participation in the training or follow-up phases
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 |
|---|---|---|
| Theory-Based Menstrual and Hygiene Education ProgramThis is a structured, face-to-face menstrual and hygiene education program based on Bandura's Social Learning Theory, developed for visually impaired young women. The intervention aims to improve menstrual self-care skills, genital hygiene behaviors, and symptom management. The training includes verbal instruction, modeling, reinforcement techniques, tactile materials, and audio-described educational videos. Interactive games and small-group activities (max 4 participants) are used to support engagement and skill development. Each session lasts approximately half a day (3-4 hours). Educational content was reviewed by experts and piloted for accessibility. The program addresses cognitive, behavioral, and sensory learning needs to support independent menstrual hygiene management in visually impaired women. | Behavioural | Intervention Group |
Primary outcome
Menstruation Symptom Questionnaire
Time frame: Baseline and 9 months after intervention
Developed by Chesney and Tasto (1975) to assess menstrual pain and symptoms, the scale was updated by Negriff et al. (2009) by re-evaluating its factor structure and usability in adolescents. Turkish validity and reliability were established by Güvenç et al. (2014). The scale is a 5-point Likert-type scale consisting of 22 items. Participants are asked to rate their menstrual symptoms on a scale of 1 (never) to 5 (always). The scale consists of three sub-dimensions: Negative Effects/Somatic Complaints (Items 1-13), Menstrual Pain Symptoms (Items 14-19), and Coping Mechanisms (Items 20-22). The lowest possible score is 22, and the highest is 110. The average of the total scores obtained from the items on the scale provides the scale score. An increase in the average score indicates an increase in the severity of menstrual symptoms. The score obtained from the sub-dimensions of the scale is calculated by calculating the average total score of the item
Genital Hygiene Behavior Scale
Time frame: Baseline and 9 months after intervention
Genital Hygiene Behavior Scale Developed by Karahan in 2017, this scale measures women's genital hygiene behaviors. It consists of three sub-dimensions: "General Hygiene " (12 items), "Menstrual Hygiene" (8 items), and " abnormal finding awareness" (3 items). The minimum scale score is 23, and the maximum is 115. The scale has 23 items, using a five-point Likert scale. Items are rated from "strongly agree = 5" to "strongly disagree = 1". As the score on the scale increases, the rate at which women exhibit correct genital hygiene behavior also increases. The Cronbach's alpha values for the scale are 0.80 for "Genital Hygiene Behaviors Scale", 0.70 for "Genital Hygiene Habits", 0.74 for "Menstrual Hygiene", and 0.8 for " abnormal finding awareness", respectively (Karahan, 2017).
Menstrual Self-Care Skills Checklist
Time frame: Evaluated before and immediately after the intervention.
The researcher prepared this skills checklist based on the literature. It consists of three sections: Menstruation Tracking Skills, Pad Changing Skills, and Genital Hygiene Skills. "No" is scored as "0", "Partially knowing" as "1", and "Yes" as "2". Expert evaluation was obtained to assess the content validity of the checklists. Menstruation Tracking Skills; There are 7 items related to knowing the signs that menstruation, determine the day menstruation will begin, knowing the duration of menstrual bleeding, the frequency of menstruation, monitoring bleeding, and noticing pad fullness. The Pad Changing Skill consists of eight items in total. The steps are: removing the soiled pad from the underwear, removing and discarding the packaging of the clean pad, placing the clean pad into the underwear, and securing it to the underwear. Genital Hygiene Skills; This section includes seven items related to hand washing and genital cleaning.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Menstruation Hygiene
RecruitingObservational study
Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
Primary Immune Deficiency Diseases
Recruiting
Impact Evaluation of Accelerating Climate-Resilient Water, Sanitation and Hygiene Services for Schools and Healthcare Facilities in Karamoja
Diarrhea, Respiratory Tract Infections (RTI)
Active, not recruiting
An MHH Intervention in Bangladesh Health Systems
Menstrual Health Intervention, Product Use Issue
Enrolling by invitation
Effect of Hygiene and Menstrual Hygiene Interventions on Learning and Psychosocial Wellbeing in Madagascar
Urinary Tract Infections, Malnutrition
Active, not recruiting
AI-Based Education and Menstrual Health Behaviors in Adolescents
Artificial Intelligence, Self-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. This study is not recruiting at the moment.
Özlem Demirel Bozkurt, Associate Professor, PhD, RN principal investigator
Ege University Nursing Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theory-Based Menstrual and Hygiene Education Program in people with Menstruation Hygiene and Menstruation, run by Aylin Olgun 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 26 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Menstruation Symptom Questionnaire (time frame: Baseline and 9 months after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2026.