NCT05938660

Brief Summary

The goal of this non-invasive interventional study is to explore the university students' experience of living with primary dysmenorrhea and evaluate the effect of acupuncture at the Sanyinjiao point on their physiological discomfort. The main questions it aims to answer are:

  • Is there any difference in pain before and after the intervention of the Sanyinjiao point acupressure for dysmenorrhea among female college students?
  • Is there any difference in the average number of Menstrual Distress Questionnaire scale before and after Sanyinjiao acupressure in female college students with dysmenorrhea? Participants will be acupressure at Sanyinjiao point triple times during the study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

July 3, 2023

Last Update Submit

July 3, 2023

Conditions

Keywords

Sanyinjiao acupointDysmenorrhea

Outcome Measures

Primary Outcomes (2)

  • the Visual Pain Scale (VAS)

    Data collection helps to understand the pain index of college students with primary dysmenorrhea during menstruation. Descriptive statistics (mean, standard deviation (SD), frequency, mean difference), Chi-square test nd ANOVA statistical testswere used for data analysis.

    Pre-test (On the fourth day of menstrual cycle.), Visit 1(On the fourth day of menstrual cycle.), Visit 2(On the fourth day of menstrual cycle.)

  • the Menstrual Physiological Infrequency Table (MDQ)

    Data collection helps to understand the degree of physiological discomfort symptoms during menstruation in college students with primary dysmenorrhea. Descriptive statistics (mean, standard deviation (SD), frequency, mean difference), Chi-square test nd ANOVA statistical testswere used for data analysis.

    Pre-test (On the fourth day of menstrual cycle.), Visit 1(On the fourth day of menstrual cycle.), Visit 2(On the fourth day of menstrual cycle.)

Study Arms (1)

Acupressure group

EXPERIMENTAL

The participants received a 5-minutes acupressure on Sanyinjiao point of both legs per day from 5 days ago of one period untill the third day of the period. The participants received the same intervention in the coming period again.

Other: acupressure at Sanyinjiao point

Interventions

When pressing Sanyinjiao point, the subject should be in a comfortable sitting position. Press the acupoints with the thumb until the subject feels soreness, then press and knead in a circle according to the strength acceptable to the subject. Press and knead once a second, and rest for 1 second every 5 seconds are one cycle, the speed is 10 cycles/minute, and it lasts for five minutes.

Acupressure group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A. Dysmenorrhea in the past six months, lower abdominal pain one or two days before menstruation or the first and second day of menstruation.
  • B. Dysmenorrhea will affect women's daily life, and those whose VAS score is greater than 5 points are female college students with moderate to severe pain.
  • C. The menstrual cycle is 21-35 days, and menstruation lasts 3-7 days. D. Female college students aged 18\~30

You may not qualify if:

  • A. Pregnant women or women who have given birth, breastfeeding, taken contraceptives, and have contraceptive devices.
  • B. Previous uterine or pelvic surgery, severe uterine and pelvic infection. C. Have a major disease: cancer, heart disease, hyperthyroidism, etc. Strong pain will affect the performance of menstrual pain and other diseases.
  • D. There is wound, inflammation or skin damage on the skin of Sanyinjiao acupoints on both sides.
  • E. Use of traditional Chinese medicine for dysmenorrhea in the past three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asia University

Taichung, Taiwan

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Nai-Huan Hsiung, PhD

    Assistant Professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 10, 2023

Study Start

November 22, 2022

Primary Completion

July 1, 2023

Study Completion

August 1, 2023

Last Updated

July 10, 2023

Record last verified: 2023-07

Locations