Back to resultsEffects of Acupressure at Sanyinjiao Point on Primary Dysmenorrhea Among University Students.
Primary Purpose
Primary Dysmenorrhea, Acupuncture
Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupressure at Sanyinjiao point
Sponsored by
About this trial
This is an interventional supportive care trial for Primary Dysmenorrhea focused on measuring Sanyinjiao acupoint, Dysmenorrhea
Eligibility Criteria
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.
Sites / Locations
- Asia University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acupressure group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05938660
Brief Title
Effects of Acupressure at Sanyinjiao Point on Primary Dysmenorrhea Among University Students.
Official Title
Effects of Acupressure at Sanyinjiao Point on Primary Dysmenorrhea Among University Students.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea, Acupuncture
Keywords
Sanyinjiao acupoint, Dysmenorrhea
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupressure group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
acupressure at Sanyinjiao point
Intervention Description
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.
Primary Outcome Measure Information:
Title
the Visual Pain Scale (VAS)
Description
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.
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.)
Title
the Menstrual Physiological Infrequency Table (MDQ)
Description
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.
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.)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nai-Huan Hsiung, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Study Chair
Facility Information:
Facility Name
Asia University
City
Taichung
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Effects of Acupressure at Sanyinjiao Point on Primary Dysmenorrhea Among University Students.
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