Premenstrual SyndromeNCT00174161
The Symptom Experience of Women With Perimenstrual Syndrome;Women's Health Related Quality of Life.
An observational study of Premenstrual Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of these series research project is to investigate the prevalence, symptoms cluster and characteristic; establish the systemic symptom management nursing strategies (PMS-SMP); determine short-and long-term effectiveness of PMS-SMP. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- self-care, health behavior
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2005to Dec 2005
- Phase
- Observational
- 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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female
Who cannot join
- pregnancy,menopause,woman with breast-feeding
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
NTUH, National Taiwan University Hosptal
Taipei, 7, Chung-Shan South Road, 100
About this study
The purpose of these series research project is to investigate the prevalence, symptoms cluster and characteristic; establish the systemic symptom management nursing strategies (PMS-SMP); determine short-and long-term effectiveness of PMS-SMP. To enhance the health related quality of life of women with Perimenstrual syndrome. Simultaneously, the PMS-SMP offers a research and clinical based protocol to demonstrate the independent nursing role and practice care model. The 3-year series research process will include three research domains.
Read the detailed description
Symptoms are the most common reason people seek health care. Although the menstrual cycle, a normative process, but 10~15% of western women experience sever recurring symptoms associated with the menstrual cycle that can be considered a chronic illness. There are many interventional researches focus on this issue in western countries. There is not only lack of evidence base prevalence of perimenstrual syndrome, but also never found any nursing intervention project focusing on women with perimenstrual syndrome.
The purpose of these series research project is to investigate the prevalence, symptoms cluster and characteristic; establish the systemic symptom management nursing strategies (PMS-SMP); determine short-and long-term effectiveness of PMS-SMP. To enhance the health related quality of life of women with Perimenstrual syndrome. Simultaneously, the PMS-SMP offers a research and clinical based protocol to demonstrate the independent nursing role and practice care model. The 3-year series research process will include three research domains.
Content analysis, descriptive statistics(percentage, mode, medium, quartile, rank), Chi-square, One way ANOVA, MANCOVA, and Step-Wise regression will be applied to examine the research finding. Although focused on perimenstrual symptoms relief and improve the health related quality of life of women with perimenstrual symptoms, these strategies are generally health promoting and can be applied to other women's health conditions.
- Conditions
- Premenstrual Syndrome
- Being tested
- self-care, health behavior
- Keywords
- Premenstrual Syndrome,Health Related Quality of Life
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-care, health behaviorBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Yang Ya Ling, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174161
- Sponsor's protocol ID
- 9461700617
- Other IDs
- NSC93-2314-B002-054, NSC94-2314-B002-009
- Status last verified
- Jul 2005
- First submitted
- 13 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Symptom Experience of Women With Perimenstrual Syndrome;Women's Health Related Quality of Life.
- ClinicalTrials.gov ID
- NCT00174161
- Acronym / sponsor ID
- 9461700617
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual Syndrome,Health Related Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2005
- Study completion
- Dec 2005
- First posted
- 15 Sep 2005 (estimated)
- 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 purpose of these series research project is to investigate the prevalence, symptoms cluster and characteristic; establish the systemic symptom management nursing strategies (PMS-SMP); determine short-and long-term effectiveness of PMS-SMP. To enhance the health related quality of life of women with Perimenstrual syndrome. Simultaneously, the PMS-SMP offers a research and clinical based protocol to demonstrate the independent nursing role and practice care model. The 3-year series research process will include three research domains.
Detailed description
Symptoms are the most common reason people seek health care. Although the menstrual cycle, a normative process, but 10~15% of western women experience sever recurring symptoms associated with the menstrual cycle that can be considered a chronic illness. There are many interventional researches focus on this issue in western countries. There is not only lack of evidence base prevalence of perimenstrual syndrome, but also never found any nursing intervention project focusing on women with perimenstrual syndrome.
The purpose of these series research project is to investigate the prevalence, symptoms cluster and characteristic; establish the systemic symptom management nursing strategies (PMS-SMP); determine short-and long-term effectiveness of PMS-SMP. To enhance the health related quality of life of women with Perimenstrual syndrome. Simultaneously, the PMS-SMP offers a research and clinical based protocol to demonstrate the independent nursing role and practice care model. The 3-year series research process will include three research domains.
Content analysis, descriptive statistics(percentage, mode, medium, quartile, rank), Chi-square, One way ANOVA, MANCOVA, and Step-Wise regression will be applied to examine the research finding. Although focused on perimenstrual symptoms relief and improve the health related quality of life of women with perimenstrual symptoms, these strategies are generally health promoting and can be applied to other women's health conditions.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female
Key exclusion criteria (1 listed)
- pregnancy,menopause,woman with breast-feeding
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 |
|---|---|---|
| self-care, health behavior | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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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.
Yang Ya Ling study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premenstrual Syndrome, run by National Taiwan University Hospital 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 1 inclusion and 1 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 15 Sep 2005. 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?
Contact Yang Ya Ling, Master (886-2-23123456 ext. 8434, ylyang@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 15 Sep 2005.