The Symptom Experience of Women With Perimenstrual Syndro... | NCT00174161

Studies
The Symptom Experience of Women With Perimenstrual Syndrome;Women's Health Related Quality of Life.

NCT00174161

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Sep 15, 2005Estimated

Enrollment

1,000

Phase

Not provided

Conditions

Premenstrual Syndrome

Interventions

self-care, health behavior

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Not provided

Completion Date

Dec 2005

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2005

Last Update Posted Date

Sep 15, 2005Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Taiwan University HospitalOTHER

Collaborators

Name	Class
National Science and Technology Council, Taiwan	OTHER_GOV

Description Module

Brief 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. 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000

Name	Type	Description	Arm Group Labels	Other Names
self-care, health behavior	Behavioral

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

female

Exclusion Criteria:

pregnancy,menopause,woman with breast-feeding

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yang Ya Ling, Master	Contact	886-2-23123456	8434	ylyang@ha.mc.ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Yang Ya Ling	National Taiwan University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NTUH, National Taiwan University Hosptal	Recruiting	Taipei	7, Chung-Shan South Road	100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D011293	Premenstrual Syndrome

Ancestor Terms

ID	Term
D008599	Menstruation Disturbances
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012648	Self Care

Ancestor Terms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
NSC93-2314-B002-054
NSC94-2314-B002-009