UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059311 |
|---|---|
| Receipt number | R000067836 |
| Scientific Title | The Effect of Cradle Coach on Baby-Carrying Practice Among University Students |
| Date of disclosure of the study information | 2025/10/10 |
| Last modified on | 2025/10/07 07:02:39 |
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Basic information
Public title
The Effect of Cradle Coach on Baby-holding Practice Among University Students
Acronym
The Effect of Cradle Coach on Baby-holding Practice Among University Students
Scientific Title
The Effect of Cradle Coach on Baby-Carrying Practice Among University Students
Scientific Title:Acronym
The Effect of Cradle Coach on Baby-Carrying Practice Among University Students
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will conduct training on cradling techniques using the Cradle Coach with university students and examine whether improvements in self-efficacy and nurturingness are observed before and after the training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Test the following items before and after training: 14 items on infants' contact experiences, 25 items on nurturing care, 16 items on self-efficacy, 20 items on STAI, 1 open-ended item on anxiety related to holding.
Key secondary outcomes
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
Step 1: Practice holding techniques in four scenarios (holding a newborn, soothing crying)
Step 2: Interactive actions in two scenarios (looking at the face, relaxing, smiling, talking, patting, soothing words, rocking)
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
| 18 | years-old | < |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Gunma University School of Medicine, Department of Health Sciences, 2nd Year Student
Nursing students and general students enrolled in Japanese universities
Key exclusion criteria
cannot converse in Japanese
already have children
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | YOKO |
| Middle name | |
| Last name | ARAI |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8914
yk-arai@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | YOKO |
| Middle name | |
| Last name | ARAI |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8914
Homepage URL
yk-arai@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma 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
Gunma University Medical Research Ethics Review Board for Human Subjects
Address
3- 3-39-15 Showa-machi, Maebashi, Gunma
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.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
| 2025 | Year | 10 | Month | 10 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 10 | Month | 07 | Day |
Last modified on
| 2025 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067836
