Primary DysmenorrheaNCT05938660
Effects of Acupressure at Sanyinjiao Point on Primary Dysmenorrhea Among University Students.
A study testing acupressure at Sanyinjiao point in people with Primary Dysmenorrhea and Acupuncture, run by Asia University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea, Acupuncture
- What is being tested?
- acupressure at Sanyinjiao point
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Nov 2022to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Dysmenorrhea in the past six months, lower abdominal pain one or two days before menstruation or the first and second day of menstruation.
- 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.
- The menstrual cycle is 21-35 days, and menstruation lasts 3-7 days. D. Female college students aged 18~30
Who cannot join
- Pregnant women or women who have given birth, breastfeeding, taken contraceptives, and have contraceptive devices.
- 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.
- There is wound, inflammation or skin damage on the skin of Sanyinjiao acupoints on both sides.
- Use of traditional Chinese medicine for dysmenorrhea in the past three months.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Primary Dysmenorrhea, Acupuncture
- Being tested
- acupressure at Sanyinjiao point
- Keywords
- Sanyinjiao acupoint, Dysmenorrhea
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressure at Sanyinjiao pointOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: acupressure at Sanyinjiao point |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start22 Nov 2022
- Primary completionJul 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nai-Huna Hsiung, Asia University
- Investigators
- Nai-Huan Hsiung, PhD, Study chair, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938660
- Sponsor's protocol ID
- lainey2022winnie
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acupressure at Sanyinjiao Point on Primary Dysmenorrhea Among University Students.
- ClinicalTrials.gov ID
- NCT05938660
- Acronym / sponsor ID
- lainey2022winnie
- Conditions
- Primary Dysmenorrhea, Acupuncture
- Keywords
- Sanyinjiao acupoint, Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Asia UniversityUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupressure group | Experimental | Other: acupressure at Sanyinjiao pointThe 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Dysmenorrhea in the past six months, lower abdominal pain one or two days before menstruation or the first and second day of menstruation.
- 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.
- The menstrual cycle is 21-35 days, and menstruation lasts 3-7 days. D. Female college students aged 18~30
Key exclusion criteria (4 listed)
- Pregnant women or women who have given birth, breastfeeding, taken contraceptives, and have contraceptive devices.
- 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.
- There is wound, inflammation or skin damage on the skin of Sanyinjiao acupoints on both sides.
- Use of traditional Chinese medicine for dysmenorrhea in the past three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupressure at Sanyinjiao pointWhen 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. | Other | Acupressure group |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
Related trials for Primary Dysmenorrhea
Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Not yet recruiting
Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
Primary Dysmenorrhea (PD), Menstrual Pain
Recruiting
The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
Dysmenorrhea, Primary Dysmenorrhea
Not yet recruiting
The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
Dysmenorrhea Primary
Not yet recruiting
Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea
Primary Dysmenorrhea, Menstrual Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nai-Huan Hsiung, PhD study chair
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure at Sanyinjiao point in people with Primary Dysmenorrhea and Acupuncture, run by Asia University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.