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NCT Number: NCT07137663

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

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 If the participant refuses counseling or states that she no longer wishes to use the cup, she will be withdrawn from the study.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.

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Key information

Conditions

Menstrual Cup Disabled People Menstrual Hygiene Management

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Educational and practical intervention on menstrual cup use

Other

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 cup selection and usage guidance. Additionally, the intervention includes repeated follow-ups over six menstrual cycles, allowing continuous support and monitoring of the participants' experiences. This approach aims not only to improve hygiene practices but also to enhance user satisfaction and long-term adherence. The comprehensive and personalized nature of this intervention differentiates it from most existing studies and seeks to offer practical, sustainable solutions for menstrual hygiene

Primary outcomes

Change from Baseline in Satisfaction and Acceptability Levels in First-Time Menstrual Cup Users Who Use Wheelchairs after 6-Month Menstrual Periods Follow-Up

Time frame: Baseline and 6 months.

The study used a structured data collection form developed by the researcher based on the literature and expert opinions. The initial section (23 items) assessed participants' sociodemographic characteristics, parity, and menstrual hygiene management. Follow-up forms after menstrual periods 1-5 (18 items) evaluated menstrual cup use and menstrual hygiene management, while the final follow-up after the 6th menstrual period (23 items) included additional questions on satisfaction with menstrual cup use and perceived changes in menstrual hygiene management.

Satisfaction with menstrual cup use was assessed using a Likert scale regarding insertion, removal, cleaning, leakage prevention, storage, odor control, comfort during daily activities, comfort during sleep, overall comfort, and perceived advantages over other menstrual hygiene products (1 = very poor, 5 = very good). Ease of use for insertion, removal, cleaning, and storage was rated as 1 = easy, 2 = not very easy, 3 = difficult.

Secondary outcomes

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.

Time frame: Baseline and 6 months.

The study used a structured data collection form developed by the researcher based on the literature and expert opinions. The initial section (23 items) assessed participants' sociodemographic characteristics, parity, and menstrual hygiene management. Follow-up forms after menstrual periods 1-5 (18 items) evaluated menstrual cup use and menstrual hygiene management, while the final follow-up after the 6th menstrual period (23 items) included additional questions on satisfaction with menstrual cup use and perceived changes in menstrual hygiene management.The menstrual periods during which participants used menstrual cups will be compared with the periods during which they used other sanitary products; perceived changes (positive/negative/no change) in economic and social life and sleep will be measured in the final follow-up form.

Study contacts

Contact information is provided by the study sponsor or research team.

Hülya ULAŞLI KABAN

CONTACT

[email protected]

+90 5530935775

Hüsniye Dinç Kaya

CONTACT

[email protected]

+90 5336841952

Sponsors and collaborators

Lead sponsor

Hülya ULAŞLI KABAN

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2027
First posted: Aug 22, 2025
Registry last updated: Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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