UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047258 |
|---|---|
| Receipt number | R000053899 |
| Scientific Title | Development and Evaluation of an End-of-Life Family Support Education Program for Neonatal Intensive Care Unit (NICU) Nurses |
| Date of disclosure of the study information | 2022/03/23 |
| Last modified on | 2023/03/27 12:26:02 |
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Basic information
Public title
Development and Evaluation of an End-of-Life Family Support Education Program for Neonatal Intensive Care Unit (NICU) Nurses
Acronym
Development and Evaluation of an End-of-Life Family Support Education Program for Neonatal Intensive Care Unit (NICU) Nurses
Scientific Title
Development and Evaluation of an End-of-Life Family Support Education Program for Neonatal Intensive Care Unit (NICU) Nurses
Scientific Title:Acronym
Development and Evaluation of an End-of-Life Family Support Education Program for Neonatal Intensive Care Unit (NICU) Nurses
Region
| Japan |
Condition
Condition
NICU Nurses
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effectiveness of an education program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Attitude (confidence, motivation) toward end-of-life family support in the NICU (before, after, and 1 month after the course)
Key secondary outcomes
Knowledge, skills, and difficulties with end-of-life family support in the NICU (before, after, and 1 month after the course)
Satisfaction of the training (after the course)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Subjects will attend 4 hours educational programs of End-of-Life Family Support in the NICU
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nurses working in the NICU/GCU of the Comprehensive Perinatal Maternal and Child Health Center who meet the following criteria
1.NICU/GCU nurses at Clinical Ladder Level II or higher (guideline: 2-3 years or more of clinical experience)
Recommendation is equivalent to Clinical Ladder Level II-IV (guideline: less than 2-10 years of clinical experience).
2.Those with End-of-Life care experience in the NICU
3.GCU nurses must have experience working in the NICU and End-of-Life care and plan to work in the NICU in the future.
4.Those who agree with the purpose of this study and agree to participate freely and voluntarily.
Key exclusion criteria
We don't have any exclusion criteria.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | Saito |
Organization
Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name
Doctoral and Master's Program in Nursing Science
Zip code
305-8575
Address
1-1-1 Tennodai,Tsukuba City, Ibaraki, Japan
TEL
029-853-3403
s2030417@s.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Saito |
Organization
Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name
Doctoral and Master's Program in Nursing Science
Zip code
305-08575
Address
1-1-1 Tennodai,Tsukuba City, Ibaraki, Japan
TEL
029-853-3403
Homepage URL
s2030417@s.tsukuba.ac.jp
Sponsor or person
Institute
Graduate School of Comprehensive Human Sciences, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Fumiko Yamaji Fund for Professional Nursing Education and Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Medical Ethics, University of Tsukuba, School of Medicine and Health Sciences
Address
1-1-1 Tennodai,Tsukuba City, Ibaraki, Japan
Tel
029-853-3429
sien.ningenss@un.tsukuba.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
54
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 23 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053899
