UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055463 |
|---|---|
| Receipt number | R000063377 |
| Scientific Title | Stress Response to Infant Crying of Men Becoming Fathers First Time-Comparison of Viewing Educational Videos on Infant Crying- |
| Date of disclosure of the study information | 2024/09/09 |
| Last modified on | 2025/03/31 16:45:27 |
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Basic information
Public title
Stress Response to Infant Crying of Men Becoming Fathers First Time-Comparison of Viewing Educational Videos on Infant Crying-
Acronym
Stress Response to Infant Crying of Men Becoming Fathers First Time-Comparison of Viewing Educational Videos on Infant Crying-
Scientific Title
Stress Response to Infant Crying of Men Becoming Fathers First Time-Comparison of Viewing Educational Videos on Infant Crying-
Scientific Title:Acronym
Stress Response to Infant Crying of Men Becoming Fathers First Time-Comparison of Viewing Educational Videos on Infant Crying-
Region
| Japan |
Condition
Condition
Husband of a first-time pregnant woman
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to characterize the stress response to infant crying in first-time fathers with and without educational video viewing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate
Heart rate variability
Key secondary outcomes
Knowledge Acquisition for Infants
STAI
Respiratory rate
Blood pressure
Recognition of infant crying
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are 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
| Maneuver |
Interventions/Control_1
Viewing educational videos on infant crying
Interventions/Control_2
Do not watch educational videos
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
Husbands of first-time mothers who are in the second trimester (14 weeks and up) of pregnancy or later
Those who have never raised a child before.
Key exclusion criteria
Those who have experience in child rearing due to remarriage, etc.
Those with underlying medical conditions such as neurological diseases.
Those who have a smoking habit.
Those who have watched the video Baby Crying Unstoppable for Understanding and Coping with Crying used in this study.
Those who have difficulty in answering the questionnaire in Japanese.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hisayo |
| Middle name | |
| Last name | Okayama |
Organization
University of Tsukuba
Division name
School of Medicine and Medical Sciences
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
0298538372
okayama@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Sanae |
| Middle name | |
| Last name | Shimada |
Organization
University of Tsukuba
Division name
master's program in nursing science
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3251
Homepage URL
s2321379@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
029-853-3251
s2321379@u.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
| 2024 | Year | 09 | Month | 09 | 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
15
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
| 2024 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2024 | Year | 09 | Month | 09 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063377
