- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07607171
Social Learning Theory-Based Menstruation Education in Visually Impaired Women
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:
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Izmir, Tyrkiet (Türkiye)
- Ege University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention Group
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.
|
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.
|
|
Ingen indgriben: Control Group
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Menstruation Symptom Questionnaire
Tidsramme: 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
|
Baseline and 9 months after intervention
|
|
Genital Hygiene Behavior Scale
Tidsramme: 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).
|
Baseline and 9 months after intervention
|
|
Menstrual Self-Care Skills Checklist
Tidsramme: 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. |
Evaluated before and immediately after the intervention.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Özlem Demirel Bozkurt, Associate Professor, PhD, RN, Ege University Nursing Faculty
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AYLINOLGUN_VISUALLYIMPAİRMENT
- 125S056 (Andet bevillings-/finansieringsnummer: The Scientific and Technological Research Council of Türkiye (TÜBİTAK))
- 1219/1199 (Anden identifikator: İzmir Bakırçay University Non-Interventional Clinical Research Ethics Committee)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Menstruation
-
Institut National de la Santé Et de la Recherche...Afsluttet
-
Kimberly-Clark CorporationAfsluttet
-
University of British ColumbiaNational Research System-College of Family Physicians of CanadaAfsluttet
-
Stanford UniversityAfsluttetTilbageholdelse; MenstruationForenede Stater
-
Institut National de la Santé Et de la Recherche...Rekruttering
-
Essity Hygiene and Health ABAktiv, ikke rekrutterende
-
Apple Inc.ExponentAfsluttet
-
Saglik Bilimleri UniversitesiGazi UniversityAfsluttet
Kliniske forsøg med Theory-Based Menstrual and Hygiene Education Program
-
March of Dimes, CanadaHamilton Health Sciences CorporationAfsluttet
-
Omada Health, Inc.Palo Alto Medical Foundation; Sutter HealthAfsluttetType 2 diabetesForenede Stater
-
Joslin Diabetes CenterDHR Health Institute for Research and Development; Verizon FoundationAfsluttetType 2 diabetes mellitusForenede Stater
-
University of UtahUniversity of Colorado, DenverAfsluttetDiabetes mellitusForenede Stater
-
Chinese University of Hong KongIntegrated Community Care and Family Support CentresAfsluttetFamilieplejere | Skizofreni spektrum lidelserHong Kong
-
Omada Health, Inc.Abbott Diabetes Care; Evidation HealthAfsluttetType 2 diabetesForenede Stater
-
Forschungsinstitut der Diabetes Akademie MergentheimAfsluttet
-
Case Comprehensive Cancer CenterNational Institutes of Health (NIH)AfsluttetBrystkræft | Fysisk aktivitetForenede Stater
-
Anny ReyesAmerican Epilepsy SocietyRekruttering