- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07409337
Self-Acupressure for Primary Dysmenorrhea and Premenstrual Symptoms
Effects of Self-Acupressure on Primary Dysmenorrhea and Premenstrual Symptoms in Women Aged 18-30: A Randomized, Sham-Controlled, 6-Month Trial
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pınar Erdoğan, Assoc. Prof.
- Phone Number: +905233646954
- Email: drpinarerdogan@gmail.com
Study Locations
-
-
Merkez
-
Niğde, Merkez, Turkey (Türkiye), 51240
- Recruiting
- Niğde Ömer Halisdemir University Hospital
-
Contact:
- Pınar Erdoğan, Assoc. Prof.
- Phone Number: 05233646954
- Email: drpinarerdogan@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-Acupressure Intervention
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.
|
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 Comparator: 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 for 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in menstrual pain severity
Time Frame: 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.
|
Baseline and end of 6 months (approximately 5-6 menstrual cycles)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in premenstrual symptom severity
Time Frame: 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.
|
Baseline and end of 6 months
|
|
Analgesic use during menstruation
Time Frame: 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.
|
Assessed throughout the 6-month follow-up period
|
|
Menstruation-related absenteeism
Time Frame: 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.
|
Assessed throughout the 6-month follow-up period
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention adherence
Time Frame: 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.
|
Over 6 months
|
|
Participant satisfaction with the intervention
Time Frame: 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.
|
End of 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22504254-050.04/18-75
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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