Menstrual Pain, Premenstrual Syndrome, Primary Dysmenorrhea
Conditions
Keywords
Self-acupressure, Dysmenorrhea, Premenstrual symptoms, Menstrual pain, Non-pharmacological treatment, Sham-controlled trial
Brief 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.
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.
Interventions
OTHERSelf-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.
Sponsors
Nigde Omer Halisdemir University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors are blinded to group allocation. The researcher providing the self-acupressure training is not blinded due to the nature of the intervention and is not involved in outcome assessment or data analysis.
Intervention model description
This is a two-arm, parallel-group, randomized, sham-controlled clinical trial. Participants are individually randomized in a 1:1 ratio to either a verum self-acupressure intervention or a sham self-acupressure control. There is no crossover between study arms, and all participants are followed for approximately six months.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTPınar Erdoğan, Assoc. Prof.
Outcome results
None listed