UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043449 |
|---|---|
| Receipt number | R000049598 |
| Scientific Title | Development of a prenatal nursing intervention program that promotes adaptation to paternal role for first-time expectant fathers |
| Date of disclosure of the study information | 2021/02/26 |
| Last modified on | 2023/03/10 11:44:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of a prenatal nursing intervention program that promotes adaptation to paternal role for first-time expectant fathers
Acronym
Development of a prenatal nursing intervention program that promotes adaptation to paternal role for first-time expectant fathers
Scientific Title
Development of a prenatal nursing intervention program that promotes adaptation to paternal role for first-time expectant fathers
Scientific Title:Acronym
Development of a prenatal nursing intervention program that promotes adaptation to paternal role for first-time expectant fathers
Region
| Japan |
Condition
Condition
first-time expectant fathers
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to examine both quantitatively and qualitatively the effect of the prenatal nursing intervention program, originally established by the researcher, to promote adaptation to the paternal role for first-time expectant fathers before and subsequent to the childbirth
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
we examined effective prenatal education that led to awareness of their own paternal activities through semi-structured interview
Key secondary outcomes
The effect of the nursing intervention program was evaluated quantitatively by comparing the following three outcomes between the two groups: EPDS, Quality Marriage Index (QMI), and Parenting Stress Index Short Form (PSI-SF).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
The intervention program (prenatal education) allowed subjects to create postpartum schedule and experience bathing children using a paternity portfolio uniquely developed.
Interventions/Control_2
the control group under standard nursing
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
Key inclusion criteria
The conditions were as follows: (1) Japanese first-time expectant father; (2) singleton pregnancy; (3) normal course of pregnancy and the fetus; (4) no health issues that interfere with daily lives of the expectant father; (5) living together; (6) fluency in the Japanese language for communication.
Key exclusion criteria
subjects were excluded if: (1) subjects requested to withdraw; (2) subjects presented health issues; or (3) there were issues with the pregnancy, the delivery, and the postpartum course of the wife or child.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Morita |
Organization
Saitama Prefectural University
Division name
school of Health and Social service
Zip code
343-8540
Address
820 San-nomiya Koshigaya-shi Saitamaken JAPAN
TEL
+81-48-973-4316
morita-akiko@spu.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Morita |
Organization
Saitama Prefectural University
Division name
school of Health and Social service
Zip code
343-8540
Address
820 San-nomiya Koshigaya-shi Saitamaken JAPAN
TEL
+81-48-973-4316
Homepage URL
morita-akiko@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
nstitutional Review Board of Graduate School of Nursing, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba, Japan
Tel
+81-43-226-2462
kango-rinri@chiba-u.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
| 2021 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/nhs.12914
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1111/nhs.12914
Number of participants that the trial has enrolled
40
Results
Prenatal nursing program tested for fatherhood role adaptation using mixed-methods. EPDS, QMI, PSI-SF collected pre/post-intervention. No significant difference in intervention effects found in 10 intervention and 31 control groups. Participants' specific consideration of fatherhood role behaviors confirmed goal achievement. Final nursing intervention program developed based on study results.
Results date posted
| 2023 | Year | 03 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 12 | Month | 15 | Day |
Baseline Characteristics
Subjects in intervention and control groups were first-time expectant fathers who met all inclusion conditions and who and whose wife provided consent to participate in the study as a couple upon receiving explanation. The conditions were as follows: (1) Japanese first-time expectant father; (2) singleton pregnancy; (3) normal course of pregnancy and the fetus; (4) no health issues that interfere with daily lives of the expectant father; (5) living together; (6) fluency in the Japanese language for communication. Furthermore, even after the study was started upon consent provided by the couple, subjects were excluded if: (1) subjects requested to withdraw; (2) subjects presented health issues; or (3) there were issues with the pregnancy, the delivery, and the postpartum course of the wife or child.
Participant flow
Study subjects were chosen with a selection method based on participating facilities and snowball sampling method, and explanations and recruitment in the study were conducted during prenatal education offered at the facilities. Four facilities participated in the study.
In the present study, data for a control group were recorded first as the baseline data, and as soon as enough participants was included, we began collecting data for the intervention group. For the control group, we collected basic information, QMI, and EPDS while wives were in the third trimester. At two months after childbirth, we collected additional basic information, EPDS, QMI, and PSI-SF. For the intervention group, basic information, EPDS, and QMI were collected before the nursing intervention. About a week after the nursing intervention, we examined their own paternal activities that were clarified through the nursing intervention and effective prenatal education that led to awareness of such paternal activities through semi-structured interview. At two months after childbirth, additional basic information and EPDS, QMI, and PSI-SF scores were collected. Through the semi-structured interview, we collected information on actual paternal activities and effective prenatal education that led to the ideas of such paternal activities.
Adverse events
None
Outcome measures
Postpartum depression in the present study was measured using EPDS prepared by Okano, Murata, et al(1996).
For marital satisfaction, we used the QMI (translated by Moroi (1996) to measure goodness of the relationship.
Parenting stress was measured using the PSI-SF.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was presented at the 20th Annual Meeting of the Japanese Society of Maternal Nursing.
Management information
Registered date
| 2021 | Year | 02 | Month | 26 | Day |
Last modified on
| 2023 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049598
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
