Self-Acupressure for Primary Dysmenorrhea and Premenstrual Symptoms

NCT07409337 | Recruiting

• 1 other identifier: 22504254-050.04/18-75
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea; Premenstrual Syndrome; Menstrual Pain

Keywords

Self-acupressure; Dysmenorrhea; Premenstrual symptoms; Menstrual pain; Non-pharmacological treatment; Sham-controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• Change in premenstrual symptom severity

  Baseline and end of 6 months

• Analgesic use during menstruation

  Assessed throughout the 6-month follow-up period

• Menstruation-related absenteeism

  Assessed throughout the 6-month follow-up period

Other Outcomes (2)

• Intervention adherence

  Over 6 months

• Participant satisfaction with the intervention

  End of 6 months

Study Arms (2)

Self-Acupressure Intervention

EXPERIMENTAL

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

Sham Self-Acupressure

SHAM COMPARATOR

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

Interventions

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.

Self-Acupressure Intervention

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.

Sham Self-Acupressure

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Niğde Ömer Halisdemir University Hospital

Niğde, Merkez, 51240, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premenstrual Syndrome; Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Pınar Erdoğan, Assoc. Prof.

CONTACT

+905233646954; drpinarerdogan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 13, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)