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Набор скоро начнётся NCT07155291

Menstrual Pain Intervention Among Students

Без фазы С лечением Dysmenorrhea Dysmenorrhea Primary Dysmenorrhea Secondary Dysmenorrhea Symptom

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: Abdominal Self-Massage.
Кому может быть актуально
Состояния в реестре: Dysmenorrhea, Dysmenorrhea Primary, Dysmenorrhea Secondary, Dysmenorrhea Symptom. Базовые параметры: 18 лет — 45 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 →

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Официальное название

Evaluation of Easy-to-Implement Intervention for Menstrual Pain in a Series of N-of-1 Trials: Study Protocol of the Menstrual Pain Intervention Among Students Study (MPIS)

Обзор

Dysmenorrhea, or menstrual pain, is a prevalent issue among female students, which negatively influences students' productivity, academic performance, and quality of life. This study explores a non-pharmaceutical physiotherapy method that has shown potential to decrease menstrual cramping, but research on its efficacy remains limited. The intervention is a visceral abdominal self-massage. Because individuals tend to respond differently to physiotherapy methods, the investigators aim to assess the effect of performing the self-massage regularly on the self-reported perception of menstrual pain and related symptoms of female students in Germany, with a series of N-of-1 trials. N-of-1 trials lasting up to 60 days are conducted with participants who regularly experience dysmenorrhea. Participants undergo a control (A) and an intervention phase (B), with a probable second control phase (A) depending on the individual cycle lengths and study start. Daily symptoms are recorded via the StudyU smartphone application. The baseline questionnaire collects demographic, lifestyle, and menstrual history information to identify potential effect modifiers. The intervention's effects will be estimated across individual and population levels. Participants will receive access to an analysis of their data. The results may benefit individual well-being and contribute to the exploration of a more holistic approach to menstrual health.

Вмешательства

  • Поведенческое Abdominal Self-Massage
    Daily self-administered visceral abdominal massage consisting of circular motions and pressure point techniques, performed for 5-20 minutes in total based on participant preference. The massage includes two parts: belly exercises (10 exercises) and pelvic exercises (3 exercises), with each exercise repeated 5-10 times or until the area feels relaxed. The app provides instructional videos and written step-by-step guides with drawings in English and German. Participants are recommended to use oil/

Первичные конечные точки

  • Daily Perceived Menstrual Pain [Срок оценки: Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days]
Вторичные конечные точки (4)
  • Pain Medication Intake [Срок оценки: Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days]
  • Additional Menstrual Symptoms [Срок оценки: Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days]
  • Mood Impact [Срок оценки: Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days]
  • Symptom Narrative [Срок оценки: Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days]

Критерии участия

Критерии включения

  • Female students living in Germany
  • Have consistently experienced menstrual pain and other symptoms primarily during menstruation for at least the last three cycles
  • Regular access to a smartphone on which the StudyU (https://www.studyu.health/) application can be installed
  • Informed consent
  • Proficiency in English or German

Критерии исключения

  • Age under 18 or over 45 years
  • Participation in a different intervention study during the duration of this study
  • Use of hormonal treatments affecting the menstrual cycle
  • Confirmed or suspected pregnancy
  • Presence of contraindicated disorders or diseases for massage
  • Severe psychiatric conditions impairing informed consent or reliable participation
  • Substance abuse (e.g., alcohol, drugs)
  • Planned surgery within the next four to five months
  • Doctor's advice against proceeding with the intervention

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07155291 · 8/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗