The Effect of Menstrual Cup Use on Menstrual Life and Sleep Quality

NCT06718790 | Completed

• 1 other identifier: TU-HEM-ZEK-01
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Women's reproductive age is an important process that begins with menarche and ends with menopause. During this period, women need to use safe, effective and affordable products during their menstrual periods. While disposable pads and tampons are the most preferred products today, environmentally friendly and economical options also include menstrual cups, menstrual underwear and reusable pads. Menstrual cups are made of non-toxic silicone or latex, are inserted into the vagina and collect menstrual blood. Studies show that menstrual cups do not have a negative effect on the vaginal flora and most users are satisfied with the product. The environmental impact of menstrual hygiene products should also be taken into account. While disposable pads and tampons harm the environment due to their plastic content, menstrual cups are more sustainable and economical in the long term. In addition, women may experience problems with sleep quality, mood and physical comfort due to the effects of hormones during the menstrual period. However, there is no randomized controlled study yet examining the effects of menstrual cup use on sleep quality and quality of life. The aim of this study was to evaluate the effects of menstrual cup use on menstrual life and sleep quality.

Conditions

Menstrual Cup

Keywords

Menstrual Cup; Sleep Quality; Menstruation

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI)

  It was developed to evaluate sleep quality.

  The scale will be used at the end of Cycle 1, 2, 3 and 6 (each cycle is 28 days)

Secondary Outcomes (1)

• Menstruation Impact Scale

  The scale will be used at the end of Cycle 1, 2, 3 and 6 (each cycle is 28 days)

Study Arms (2)

Menstrual cup users

ACTIVE COMPARATOR

Women who will use menstrual cups will be trained on the use of the product and a menstrual cup will be provided for them to use. In the next stage, participants will be called by phone in the 1st, 2nd, 3rd and 6th menstrual cycles and asked to answer questions about their menstrual cup use by sharing an online form.

Other: Using menstrual cup

Menstrual pad users

ACTIVE COMPARATOR

For women in the group who will use menstrual pads, the average number of pads they have used in their previous menstrual cycles will be asked and an appropriate number of menstrual pads will be provided. In the next stage, participants will be called by phone in the 1st, 2nd, 3rd and 6th menstrual cycles and asked to answer questions about their menstrual pad use by sharing an online form.

Other: Using menstrual pads

Interventions

Using menstrual cup OTHER

In the prospective, randomized controlled study, two groups (Case = Menstrual cup, Control = Menstrual pad) will be randomly formed from individuals who volunteer to participate in the study and meet the inclusion criteria. All participants will be asked to answer the questions in the first interview questionnaire. Women who will use menstrual cups will be trained on the use of the product and a menstrual cup will be provided for them to use. In the next stage, participants will be called by phone in the 1st, 2nd, 3rd and 6th menstrual cycles and asked to answer questions about their menstrual cup use by sharing an online form.

Menstrual cup users

Using menstrual pads OTHER

In the prospective, randomized controlled study, two groups (Case = Menstrual cup, Control = Menstrual pad) will be randomly formed from individuals who volunteer to participate in the study and meet the inclusion criteria. All participants will be asked to answer the questions in the first interview questionnaire. For women in the group who will use menstrual pads, the average number of pads they have used in their previous menstrual cycles will be asked and an appropriate number of menstrual pads will be provided. In the next stage, participants will be called by phone in the 1st, 2nd, 3rd, and 6th menstrual cycles and asked to answer questions about their menstrual pad use by sharing an online form.

Menstrual pad users

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being between the ages of 18-45,
• Having a regular menstrual cycle between 21-35 days,
• Not having a sexually transmitted disease that has been diagnosed and treated,
• Not having a silicone allergy,
• Not using an intrauterine device,
• Not having a vaginal anatomical defect,
• Not having given birth vaginally (since a standard size menstrual cup will be used)

You may not qualify if:

• Those planning to get pregnant,
• Those with a history of sexually transmitted diseases in the last 6 months,
• Those with dysmenorrhea problems will not be included.

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, 22000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Zeliha Elkan Kiyat

  PhD student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Randomized controlled trial, there are two groups: menstrual cup users and menstrual pad users

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 5, 2024
• Study Start: August 1, 2024
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: May 21, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)