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A randomized controlled trial of a self-care program based on traditional East Asian medicine for premenstrual syndrome

A randomized controlled trial of a self-care program based on traditional East Asian medicine for premenstrual syndrome - TEAM PMS Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030240661
Enrollment
150
Registered
2025-02-05
Start date
2025-02-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premenstrual syndrome Premenstrual syndrome

Interventions

A self-care program based on traditional East Asian medicine (acupressure, exercises, and breathing)
acupressure, exercises, and breathing

Sponsors

Tomooka Kiyohide
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Women aged between 18 and 45 years at the time of consent acquisition. 2.Individuals with a regular menstrual cycle (25-38 days). 3.Individuals capable of performing acupressure on themselves. 4.Individuals capable of performing knee flexion and extension exercises. 5.Individuals who personally own a smartphone and have internet access. 6.Individuals who have received a full explanation of this study, demonstrated sufficient understanding, and provided electronic consent of their own free will.

Exclusion criteria

Exclusion criteria: 1) Individuals with a history of gynecological disorders (e.g., uterine fibroids, adenomyosis, endometriosis, ovarian cysts). 2) Individuals currently undergoing treatment for psychiatric disorders (e.g., depression, eating disorders, panic/anxiety disorders, PTSD, schizophrenia, obsessive-compulsive disorder). 3) Individuals with a history of cardiovascular diseases (e.g., angina, myocardial infarction). 4) Individuals with a history of stroke or cancer. 5) Individuals who are pregnant, planning to become pregnant during the study period, or currently breastfeeding. 6) Individuals who have started new medication for PMS or changed their medication (dose/type, etc.) within the three months preceding the consent date. 7) Individuals who have newly started or modified complementary or alternative therapies for PMS within the three months preceding the consent date. 8) Individuals who do not meet the criteria for moderate or severe PMS based on PSQ screening. 9) Individuals deemed unsuitable for study participation by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Japanese version of the Daily Records of Severity of Problems (DRSP) score

Secondary

MeasureTime frame
Online version of the Psychomotor Vigilance Test (PVT) Daytime sleepiness: Japanese version of the Epworth Sleepiness Scale (ESS) Perceived stress: Japanese version of the Perceived Stress Scale-4 (PSS-4) Health-related quality of life: Short Form-8 Health Survey (SF-8) Health perception: Japanese version of the Health Locus of Control scale Work engagement: 3-item version of the Utrecht Work Engagement Scale (UWES) Absenteeism and presenteeism Menstrual characteristics (flow volume, color, and texture) Oriental medicine health questionnaire (OHQ-57)

Contacts

Public ContactHiromi Shashiki

Juntendo University

h.shashiki.br@juntendo.ac.jp+81-358021049

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026