UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031966 |
|---|---|
| Receipt number | R000036480 |
| Scientific Title | Evaluation of Educational Program for Nurses Focusing on Early Essential Care Related to Milk Expression for Mothers of Preterm Infants |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2020/04/06 16:15:38 |
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Basic information
Public title
Evaluation of Educational Program for Nurses Focusing on Early Essential Care Related to Milk Expression for Mothers of Preterm Infants
Acronym
Evaluation of Educational Program for Nurses Focusing on Early Essential Care Related to Milk Expression for Mothers of Preterm Infants
Scientific Title
Evaluation of Educational Program for Nurses Focusing on Early Essential Care Related to Milk Expression for Mothers of Preterm Infants
Scientific Title:Acronym
Evaluation of Educational Program for Nurses Focusing on Early Essential Care Related to Milk Expression for Mothers of Preterm Infants
Region
| Japan |
Condition
Condition
Premature delivery
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of educational program for nurses focusing on early essential care related to milk expression for mothers of preterm infants. Evaluation of this educational program by nurses is also included.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nurses' knowledge about care related to breast milk expression (three months prior to the educational program, just before the educational program, just after the educational program, three months after the educational program)
Key secondary outcomes
Nurses' attitude about care related to breast milk expression (three months before the educational program, just before the educational program, just after the educational program, three months after the educational program), Nurses' status of implementation of care (three months before the educational program, just before the educational program, three months after the educational program), Mothers' amount of breast milk (on the fourth day and on the tenth day after delivery), Timing of initiation of breast milk expression, Number of times of breast milk expression (for 10 days after delivery), Mothers' perception of nurses' care related to breast milk expression (after discharge), Nurses' evaluation of educational program (three months after the educational program)
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
| Behavior,custom |
Interventions/Control_1
Carry out the educational program for nurses focusing on early essential care related to breast milk expression for mothers of preterm infants in 60 minutes. The follow-up is also included three months after the educational program.
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
34 nurses and midwives who are working in the maternity ward in a perinatal medical center and providing care for mothers of preterm infants (16 mothers who are delivering an infant with a gestational age of less than 35 weeks in the hospital where nurses who participate in this study are working, expressing breast milk to breastfeed their own baby, and being admitted to the maternity ward)
Key exclusion criteria
Nurses and midwives who are not applicable to key inclusion criteria (Mothers who did not recover enough after confinement, or mothers whose infants were in serious condition)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Rie |
| Middle name | |
| Last name | Tanaka |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science
Zip code
1040044
Address
10-1, Akashi-cho, Chuo-ku, Tokyo
TEL
03-3543-6391
16dn011@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Tanaka |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science
Zip code
1040044
Address
10-1, Akashi-cho, Chuo-ku, Tokyo
TEL
03-3543-6391
Homepage URL
16dn011@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
Teikyo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of St. Luke's International University
Address
10-1, Akashi-cho, Chuo-ku, Tokyo
Tel
03-5550-2423
kenkyukikaku@luke.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
| 2018 | Year | 06 | Month | 01 | 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
47
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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 29 | Day |
Last modified on
| 2020 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036480
