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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031966
Receipt No. 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

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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
Email 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
Email 16dn011@slcn.ac.jp

Sponsor
Institute St. Luke's International University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036480

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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