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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05938660
Other study ID # lainey2022winnie
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 22, 2022
Est. completion date August 2023

Study information

Verified date July 2023
Source Asia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 32
Est. completion date August 2023
Est. primary completion date July 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Taiwan Asia University Taichung

Sponsors (1)

Lead Sponsor Collaborator
Asia University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.)
Primary 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.)
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