Health TrialsbyHealthPanel

Self-Acupressure for Primary Dysmenorrhea and Premenstrual Symptoms

ConditionsPrimary DysmenorrheaPremenstrual SyndromeMenstrual Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-30
SponsorNigde Omer Halisdemir University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Self-Acupressure

    Other intervention

    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 intervention

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Self-Acupressure InterventionExperimental treatment 1 intervention
Group B: Sham Self-AcupressureSham comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

1

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
2

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nigde Omer Halisdemir University

Lead sponsor

Source ClinicalTrials.gov
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