An interventional study of Self-Acupressure and Sham Self-Acupressure in Primary Dysmenorrhea, Premenstrual Syndrome and Menstrual Pain, sponsored by Nigde Omer Halisdemir University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Nigde Omer Halisdemir University · Not applicable, Interventional, and Treatment
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.
177 studies on the registry are indexed under Premenstrual Syndrome; 32 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 154 interventional studies indexed under Premenstrual Syndrome.
Browse Premenstrual Syndrome studies →Nigde Omer Halisdemir University is the lead sponsor of 93 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Other: 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 for approximately six consecutive menstrual cycles.
Other: Sham 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.
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.
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)
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.
Time frame: Assessed throughout the 6-month follow-up period
Intervention adherence
Adherence to the self-acupressure protocol, calculated as the percentage of completed sessions out of the total prescribed sessions based on participant logs.
Time frame: Over 6 months
Participant satisfaction with the intervention
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.
Time frame: End of 6 months
Plan to share: No — Individual participant data will not be shared publicly. De-identified data will be stored securely and used only for the purposes of this study and related publications, in accordance with institutional ethics approval.
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