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Набор скоро начнётся NCT07137663

The Use of Menstrual Cups in the Menstrual Health and Hygiene Management of Women Who Use Wheelchairs

Без фазы С лечением Menstrual Cup Menstrual Hygiene Management Disabled People

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Educational and practical intervention on menstrual cup use.
Кому может быть актуально
Состояния в реестре: Menstrual Cup, Menstrual Hygiene Management, Disabled People. Базовые параметры: 15 лет — 49 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Investigation of the Use of Menstrual Cups in the Menstrual Health and Hygiene Management of Women Using Wheelchairs

Обзор

This study is designed to evaluate the impact of menstrual cup use on menstrual health and hygiene management among women who use wheelchairs.In addition, the study will serve as a reference for future research that includes other groups of people with disabilities and will contribute to the literature. The main questions it aims to answer are: How does menstrual cup use affect the menstrual hygiene management experiences of women who use wheelchairs? What impact does menstrual cup use have on women's comfort, perception of hygiene, and participation in social life? Do women's knowledge, attitudes, and satisfaction levels regarding menstrual cup use change over time? Why do women who use wheelchairs choose to use or not to use menstrual cups? This quasi-experimental study will use a repeated measures design (within-subjects design). Participants included in the study will be scheduled for an appointment to receive training on menstrual cup use and to be provided with a menstrual cup. The training will be conducted face-to-face in the education room of the relevant association. During this session, the participant will first respond to the initial part of the questionnaire. Following that, she will receive training on menstrual cup use (supported by video, models, etc.), and based on the information obtained, a menstrual cup in a suitable size will be provided. The menstrual cups to be used by the participants will be supplied by the researcher. After the initial meeting, six follow-up interviews will be conducted following the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual periods. In each session, participants will be asked to complete a follow-up-specific questionnaire, and any questions they have will be answered. Their use of the menstrual cup will be assessed during each follow-up. If a participant is not using the cup, the reasons for non-use will be explored, and if desired, the training will be repeated or individual counseling will be provided. If the participant refuses counseling or states that she no longer wishes to use the cup, she will be withdrawn from the study. If a participant drops out during the first three follow-ups, a new participant will be recruited to replace her.

Вмешательства

  • Другое Educational and practical intervention on menstrual cup use
    The intervention implemented in this study is a unique approach tailored to menstrual hygiene management among women who use wheelchairs. What distinguishes this intervention from others is the combination of both education and practical support for menstrual cup use. While menstrual hygiene management in the literature generally targets the general population, this study specifically addresses the unique needs and challenges faced by women with disabilities by providing individualized menstrual

Первичные конечные точки

  • Change from Baseline in Satisfaction and Acceptability Levels in First-Time Menstrual Cup Users Who Use Wheelchairs after 6-Month Menstrual Periods Follow-Up [Срок оценки: Baseline and 6 months.]
Вторичные конечные точки (1)
  • Composite questionnaires in Change from baseline in menstrual hygiene management (social life, economic aspects, and overall comfort) compared to the previous menstrual hygiene product at the 6th menstrual period. [Срок оценки: Baseline and 6 months.]

Критерии участия

Критерии включения

  • Having previously used a method other than a menstrual cup during menstruation,
  • Being between 18 and 45 years of age,
  • Having a regular menstrual cycle between 21-35 days,
  • Not having a diagnosed and treated sexually transmitted infection,
  • Not having a silicone allergy,
  • Not having a known vaginal anatomical defect,
  • Being able to actively use both arms and hands.

Критерии исключения

  • Planning to become pregnant,
  • Having had a urogenital tract infection in the past 3 months (based on self-report),
  • Having known conditions such as fibroids, endometritis, gynecological disorders, renal colic, or hydronephrosis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Wilbur J, Torondel B, Hameed S, Mahon T, Kuper H. Systematic review of menstrual hygiene management requirements, its barriers and strategies for disabled people. PLoS One. 2019 Feb 6;14(2):e0210974. doi: 10.1371/journal.pone.0210974. eCollection 2019. PMID 30726254
  • Weerawatsopon, S., Luangdansakul, W., Prommas, S., Smanchat, B., Bhamarapravatana, K., Suwannarurk, K., 2021, Comparative study of satisfaction and acceptability between using menstrual cup versus sanitary pads in health care personnel: A randomized crossover trial, Journal of the Medical Association of Thailand, 104 (1).
  • van Eijk AM, Zulaika G, Lenchner M, Mason L, Sivakami M, Nyothach E, Unger H, Laserson K, Phillips-Howard PA. Menstrual cup use, leakage, acceptability, safety, and availability: a systematic review and meta-analysis. Lancet Public Health. 2019 Aug;4(8):e376-e393. doi: 10.1016/S2468-2667(19)30111-2. Epub 2019 Jul 16. PMID 31324419
  • Singh R, Agarwal M, Sinha S, Chaudhary N, Sinha HH, Anant M. Study of Adaptability and Efficacy of Menstrual Cups in Managing Menstrual Health and Hygiene: A Descriptive Longitudinal Study. Cureus. 2022 Sep 28;14(9):e29690. doi: 10.7759/cureus.29690. eCollection 2022 Sep. PMID 36187174
  • Shihata, A. A., Brody, S., 2019, Five year study of a unique, eco-friendly, menstrual cup, that enhances the quality of women's lives during menstruation, Journal of Gynecology and Obstetrics, 7, 161-165.
  • Rinku, N.J., 2022, Experience of female wheelchair users' personal hygiene management during menstruation. Doctoral Thesis. Bangladesh Health Professions Institute, Faculty of Medicine, the University of Dhaka, Banglades
  • Hennegan J, Orozco A, Head A, Marino JL, Jayasinghe Y, Lim MSC. Menstrual cup acceptability and functionality in real-world use: A cross-sectional survey of young people in Australia. Aust N Z J Obstet Gynaecol. 2025 Jun;65(3):382-389. doi: 10.1111/ajo.13910. Epub 2024 Dec 13. PMID 39670424
  • Dündar, T., Özsoy, S., 2025, The use of menstrual cups among visually impaired women, British Journal of Visual Impairment, 43 (2), 423-436.

Идентификаторы

NCT: NCT07137663 · 2025/343

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗