Self-Acupressure for Primary Dysmenorrhea and Premenstrual Symptoms

Официальное название

Effects of Self-Acupressure on Primary Dysmenorrhea and Premenstrual Symptoms in Women Aged 18-30: A Randomized, Sham-Controlled, 6-Month Trial

Обзор

This randomized, sham-controlled trial aims to evaluate the effects of self-administered acupressure on menstrual pain severity and premenstrual symptoms in women aged 18-30 years with primary dysmenorrhea. Participants will be randomly assigned to either a self-acupressure intervention group or a sham self-acupressure control group. The intervention will be applied during the premenstrual and menstrual periods over approximately six months. The primary outcome is the change in menstrual pain severity, and secondary outcomes include changes in premenstrual symptom severity, analgesic use, and menstruation-related activity limitation.

Подробное описание

Primary dysmenorrhea and premenstrual syndrome are highly prevalent conditions among women of reproductive age and are associated with substantial impairment in quality of life, academic or work performance, and daily functioning. Although pharmacological treatments such as nonsteroidal anti-inflammatory drugs and hormonal contraceptives are commonly used, they may be ineffective, contraindicated, or undesirable for some individuals. Therefore, non-pharmacological, low-cost, and self-administered approaches are of clinical interest.

This study is a randomized, parallel-group, sham-controlled clinical trial designed to investigate the effectiveness of a self-acupressure protocol on menstrual pain and premenstrual symptoms. Eligible participants are women aged 18-30 years with regular menstrual cycles and clinically significant primary dysmenorrhea and premenstrual symptoms. Participants are randomized in a 1:1 ratio to either a verum self-acupressure group or a sham self-acupressure group.

The verum intervention consists of self-administered acupressure applied to predefined acupoints (SP6, CV4, ST36, and LV3), while the sham intervention uses non-acupoint locations near the same anatomical regions. Both interventions are matched in terms of training, session duration, frequency, and pressure intensity. Participants are instructed to perform acupressure daily during the premenstrual phase and on the first days of menstruation across approximately five to six consecutive menstrual cycles.

Outcome assessments are conducted at baseline and at the end of the six-month follow-up period. The primary outcome is the change in menstrual pain severity measured by a visual analog scale. Secondary outcomes include changes in premenstrual symptom severity scores, analgesic consumption, and menstruation-related school or work absenteeism. Adherence and participant-reported feasibility are also recorded. The study is conducted under minimal-risk conditions, and all participants provide written informed consent prior to enrollment.

Вмешательства

• Другое Self-Acupressure
  Participants receive structured training in self-administered acupressure at predefined acupoints (SP6, CV4, ST36, and LV3). Training is provided face-to-face at baseline. Participants are instructed to apply acupressure using moderate, comfortable, non-painful pressure during the premenstrual phase and the first days of menstruation across approximately six consecutive menstrual cycles.
• Другое Sham Self-Acupressure
  Participants receive structured training in sham self-acupressure matched to the experimental intervention in terms of training format, session duration, frequency, and pressure intensity. Sham acupressure is applied at non-acupoint locations adjacent to the same anatomical regions as the experimental points, using moderate, comfortable, non-painful pressure during the premenstrual phase and the first days of menstruation across approximately six menstrual cycles.

Первичные конечные точки

• Change in menstrual pain severity [Срок оценки: Baseline and end of 6 months (approximately 5-6 menstrual cycles)]

Вторичные конечные точки (3)

• Change in premenstrual symptom severity [Срок оценки: Baseline and end of 6 months]
• Analgesic use during menstruation [Срок оценки: Assessed throughout the 6-month follow-up period]
• Menstruation-related absenteeism [Срок оценки: Assessed throughout the 6-month follow-up period]

Критерии участия

Критерии включения

• Female participants aged 18 to 30 years
• Regular menstrual cycles (21-35 days)
• Diagnosis of primary dysmenorrhea with moderate to severe menstrual pain
• Presence of premenstrual symptoms consistent with premenstrual syndrome
• Currently enrolled as a university student
• Willingness to perform self-acupressure as instructed for approximately six menstrual cycles
• Ability to understand the study procedures and provide written informed consent

Критерии исключения

• Secondary dysmenorrhea (e.g., endometriosis, uterine fibroids, pelvic inflammatory disease)
• Current use of hormonal contraceptives or hormonal therapy within the past 3 months
• Pregnancy or breastfeeding
• Chronic gynecological, endocrine, or systemic disease that may affect menstrual pain or symptoms
• Regular use of analgesic or anti-inflammatory medications outside menstruation
• Prior formal training or regular practice of acupuncture or acupressure
• Inability to comply with study procedures or follow-up schedule

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Niğde Ömer Halisdemir University Hospital — Niğde

Идентификаторы

NCT: NCT07409337 · 22504254-050.04/18-75

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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