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Self-Acupressure for Primary Dysmenorrhea and Premenstrual Symptoms

NCT07409337 — Not applicable, Recruiting, 120 participants, Nigde Omer Halisdemir University

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

RegistryNCT07409337
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment120 (Estimated)
SponsorNigde Omer Halisdemir University (Other)
ConditionsPrimary Dysmenorrhea, Premenstrual Syndrome, Menstrual Pain
InterventionsSelf-Acupressure, Sham Self-Acupressure (Other)
Datesstart 2026-02-15, primary completion 2026-12-15 (estimated), completion 2026-12-15 (estimated), first posted 2026-02-13, last updated 2026-08-24
Locations1 site in Turkey (Türkiye)

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-Summary

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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Self-Acupressure InterventionExperimentalOther: Self-AcupressureParticipants receive structured training in self-administered acupressure at predefined acupoints (SP6, CV4, ST36, and LV3). Participants are instructed to apply acupressure using moderate, comfortable, non-painful pressure during the premenstrual phase and the first days of menstruation for approximately six consecutive menstrual cycles. The intervention is performed according to the study protocol in addition to usual care.
Sham Self-AcupressureSham comparatorOther: Sham Self-AcupressureParticipants 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 for approximately six consecutive menstrual cycles.
  • Self-Acupressure (Other): 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-Acupressure (Other): 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.

+Outcome measures

Primary outcomes

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

Secondary outcomes

  • Change in premenstrual symptom severity [Baseline and end of 6 months]: 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.
  • Analgesic use during menstruation [Assessed throughout the 6-month follow-up period]: Use of analgesic medication during menstruation, recorded as the number of days and/or doses of analgesic intake per menstrual cycle.
  • Menstruation-related absenteeism [Assessed throughout the 6-month follow-up period]: Number of school or work days missed due to menstrual pain or premenstrual symptoms, self-reported by participants.

Other outcomes

  • Intervention adherence [Over 6 months]: Adherence to the self-acupressure protocol, calculated as the percentage of completed sessions out of the total prescribed sessions based on participant logs.
  • Participant satisfaction with the intervention [End of 6 months]: Participant-reported satisfaction with the intervention assessed using a single-item numeric rating scale ranging from 0 to 10, where higher scores indicate greater satisfaction.

+Eligibility

Sex: Female, ages: 18 Years to 30 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Niğde Ömer Halisdemir University HospitalNiğde, MerkezTurkey (Türkiye)Recruiting

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