Effects of Acupressure at Sanyinjiao Point on Primary Dysmenorrhea Among University Students.

July 3, 2023 updated by: Nai-Huna Hsiung, Asia University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will employ a quasi-experimental research design, using pre- and post-intervention surveys in intervention. In the universities of central Taiwan as a place to collect cases. Target 50 university students with primary dysmenorrhea will be recruited by using a purposive sampling. After taking the informed consent and basic information of the study participants, the observation will be measured before and after the intervention of the Sanyinjiao point acupuncture, which were performed during two consecutive menstrual cycles (eight days per cycles). The data collection will be obtained by demographic questionnaire, the Visual Pain Scale (VAS) and the Menstrual Physiological Infrequency Table (MDQ). Descriptive statistics (mean, standard deviation (SD), frequency, mean difference), Chi-square test and ANOVA statistical testswere used for data analysis.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • Asia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupressure group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Visual Pain Scale (VAS)
Time Frame: 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.)
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)
Time Frame: 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.)
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.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asia University

Investigators

  • Study Chair: Nai-Huan Hsiung, PhD, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2022

Primary Completion (Estimated)

July 1, 2023

Study Completion (Estimated)

August 1, 2023

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lainey2022winnie

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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