Status Approved
First Submitted Date
2021/02/18
Registered Date
2021/03/08
Last Updated Date
2021/02/18
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005968 |
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Unique Protocol ID | H-2004-116-006 |
Public/Brief Title | Research on Evaluation of Postpartum health care service in Korean Medicine: Qualitative study on participants' experience |
Scientific Title | Research on Evaluation of Postpartum health casr service in Korean Medicine: Qualitative study on participants' experience |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | H-2004-116-006 |
Approval Date | 2020-05-07 |
Institutional Review Board Name | National Medical Center Institutional Review Board |
Institutional Review Board Address | 245, Eulji-ro, Jung-gu, Seoul |
Institutional Review Board Telephone | 02-2260-7014 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Joohee Seo |
Title | KMD, Ph.D., Hakomi |
Telephone | +82-2-2260-7454 |
Affiliation | National Medical Center |
Address | 245, Eulji-ro, Jung-gu, Seoul, Republic of Korea |
Contact Person for Public Queries | |
Name | Hansong Park |
Title | KMD, MDds |
Telephone | +82-2-2260-7454 |
Affiliation | National Medical Center |
Address | 245, Eulji-ro, Jung-gu, Seoul, Republic of Korea |
Contact Person for Updating Information | |
Name | Hansong Park |
Title | KMD,MSc |
Telephone | +82-2-2260-7454 |
Affiliation | National Medical Center |
Address | 245, Eulji-ro, Jung-gu, Seoul, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-08-18 Actual | |
Target Number of Participant | 10 | |
Primary Completion Date | 2021-01-28 , Actual | |
Study Completion Date | 2021-01-28 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | National Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-08-18 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | National Medical Center |
Organization Type | Medical Institute |
Project ID | H-2004-116-006 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | National Medical Center |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | background: Low birth rate, increase in elderly birth Low awareness of postpartum care Related health industry focused solely on raising fertility rates The need for postpartum medical intervention is rising and the increasing number of patients with postpartum wind. Need for research: Resolving the low birth rate problem has been a common goal of each government for the past 10 years, and several support projects have been carried out, but the effect is insignificant. Korean women are more concerned about postpartum wind, and high-risk pregnant women tend to be higher. Herbal postpartum treatment has had a positive effect on the quality of life after childbirth. In order to strengthen the guarantee of postpartum oriental medical intervention and use it as a basis for Korean medical public medical support in expanding maternal and child health policies and national support projects in the future. Need to hear real voices about maternal experiences purpose of the research: Qualitative Study on the Experience of Participants in Postpartum Health Care Programs -Experience of childbirth and postpartum care for vulnerable mothers -In-depth understanding of the experience of postpartum health care in oriental medicine -Developing strategies to revitalize postpartum health care projects in the future -Awareness of differences in perspectives and strategies between medical service users and providers |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Others |
Time Perspective | Others (Qualitative Research) |
Target Number of Participant | 10 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Those who have experience in participating in postpartum health care programs and those who voluntarily agree to participate in this study |
Cohort/Group Description -Interview method: Standardized open ended Interviews -What we want to find out through interviews -Experience of childbirth and postpartum care for vulnerable mothers: experiences of psychological and physical changes after childbirth, demand for economic and social support and medical support necessary for postpartum care, and an in-depth understanding of the overall postpartum care experience -In-depth grasp of the experience of oriental medicine postpartum health care: The motive for finding oriental medicine postpartum health care, expectations, effects, limitations, and improvement plans -Developing strategies for revitalizing postpartum health care projects in the future: systems, perceptions, and grounds -Awareness of differences in perspectives and strategies between health service users and providers ○ Research subject selection and ethical consideration -Only those who agree to participate in the study are selected as participants after obtaining written consent. -Asking for consent by providing information in advance that data will be collected through interviews and the contents of the interview will be recorded. -In order to protect the privacy of research participants and to keep the research data confidential, all data will be digitized and stored by locking the computer with restricted access, the subject will be coded as identification information, and the interview data will be used for research purposes only. Information is also provided to research participants on this. -Provides the relevant person in charge and contact information to inform the research participants that they can stop participating in the research at their own will, and to ask the research participants any questions related to the research |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | -Selection criteria 1. Persons with experience in participating in postpartum health care projects 2. Those who voluntarily agreed to participate in this study. -Exclusion criteria 1. When it is judged that a clinical study cannot be conducted due to a communication disorder due to a serious psychiatric condition, intellectual disability, mood disorder, and other cognitive problems |
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Sampling Method | Interviews are conducted for those who voluntarily consented through written consent |
Condition(s)/Problem(s) |
* (U00-U99)Codes for special purposes (U32.7)Puerperal wind disorder Postpartum depression postpartum stroke |
Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age No Limit~No Limit |
|
Description -Selection criteria 1. Persons with experience in participating in postpartum health care projects 2. Those who voluntarily agreed to participate in this study. |
|
Exclusion Criteria |
-Exclusion criteria 1. When it is judged that a clinical study cannot be conducted due to a communication disorder due to a serious psychiatric condition, intellectual disability, mood disorder, and other cognitive problems |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | Understanding of the experience of childbirth and postpartum care and in-depth understanding of the experience of oriental medicine postpartum health care |
|
Timepoint | After participation in the postpartum health care business of Korean medicine at the National Medical Center |
|
Secondary Outcome(s) 1 | ||
Outcome | Understanding of the experience of childbirth and postpartum care and in-depth understanding of the experience of oriental medicine postpartum health care |
|
Timepoint | After participation in the postpartum health care business of Korean medicine at the National Medical Center |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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