Self-Acupressure for Primary Dysmenorrhea and Premenstrual Symptoms

N/ANot Yet RecruitingNCT07409337

Nigde Omer Halisdemir University120 enrolled

Overview

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.

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.

Study Type

Interventions

Self-AcupressureOTHER

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.

Sham Self-AcupressureOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Change in menstrual pain severity

Change in menstrual pain severity measured using a visual analog scale (VAS, 0-10), where higher scores indicate more severe pain. The primary outcome is defined as the change in mean VAS score from baseline to the end of the 6-month follow-up period.

Time frame: Baseline and end of 6 months (approximately 5-6 menstrual cycles)

Secondary Outcomes

Change in premenstrual symptom severity

Change in premenstrual symptom severity assessed using a validated premenstrual symptom scale. Higher scores indicate greater symptom severity. Change is defined as the difference between baseline and end-of-study scores.

Time frame: Baseline and end of 6 months

Analgesic use during menstruation

Use of analgesic medication during menstruation, recorded as the number of days and/or doses of analgesic intake per menstrual cycle.

Time frame: Assessed throughout the 6-month follow-up period

Menstruation-related absenteeism

Number of school or work days missed due to menstrual pain or premenstrual symptoms, self-reported by participants.