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Research on Evaluation of Postpartum health casr service in Korean Medicine: Qualitative study on participants' experience

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

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005968
    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

    Institutional Review Board Information
    Board Approval Status Submitted approval
    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 Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    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

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    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

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name National Medical Center
    Organization Type Medical Institute
    Project ID H-2004-116-006
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name National Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    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
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    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
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    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
    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)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    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

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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