UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038940 |
|---|---|
| Receipt number | R000044408 |
| Scientific Title | Effectiveness of an educational intervention using virtual reality for coping behaviors to infant crying on the readiness of parenthood. |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2025/12/24 16:47:22 |
* 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
Effectiveness of an educational intervention using virtual reality for coping behaviors to infant crying on the readiness of parenthood.
Acronym
Effectiveness of an educational intervention using virtual reality for coping behaviors to infant crying.
Scientific Title
Effectiveness of an educational intervention using virtual reality for coping behaviors to infant crying on the readiness of parenthood.
Scientific Title:Acronym
Effectiveness of an educational intervention using virtual reality for coping behaviors to infant crying.
Region
| Japan |
Condition
Condition
No disease
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop the materials for coping behaviors to infant crying using virtual reality, and examine the effectiveness of the materials on understanding infant crying.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
knowledge of infant crying
Key secondary outcomes
knowledge of shaking infant, and predictive responses to infant crying, the readiness of parenthood
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
materials for coping behaviors to infant crying using virtual reality
Interventions/Control_2
An educational video on infant crying, developed by the Ministry of Health, Labor and Welfare
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Male and female without any child or had no experience of childcare.
2) Pregnant women and their partners.
Key exclusion criteria
1) Had difficulty communicating in Japanese, visually impaired, epilepsy, psychological disorders, or women/partners in pregnancy.
2) Had difficulty communicating in Japanese, visually impaired, epilepsy, psychological disorders or nausea and vomiting.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Watanabe |
Organization
Osaka University
Division name
Graduate School of Medicine, Health Science
Zip code
565-0871
Address
1-7 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-2520
watanabe@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Watanabe |
Organization
Osaka University
Division name
Graduate School of Medicine, Health Science
Zip code
565-0871
Address
1-7 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-2520
Homepage URL
watanabe@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka 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
Ethic Review Board Osaka University Hospital
Address
2-2 Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8286
rinri@hp-crc.med.osaka-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
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-20K21709/
Publication of results
Unpublished
Result
URL related to results and publications
https://kaken.nii.ac.jp/report/KAKENHI-PROJECT-20K21709/20K217092023hokoku/
Number of participants that the trial has enrolled
28
Results
Knowledge regarding infant crying behavior by using Infant Crying Knowledge Scale
In the intervention group, scores on the Infant Crying Knowledge Scale significantly decreased after the intervention for both pregnant women and their partners. In the control group, there was no difference in Infant Crying Knowledge Scale scores before and after viewing the video produced by the Ministry of Health, Labour and Welfare.
Results date posted
| 2025 | Year | 12 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Intervention group: 14 dyads (14 pregnant women at second trimester and 14 partners)
Control group: 14 dyads (14 pregnant women at second trimester and 14 partners)
Participant flow
Participants were recruited through registration desks of parent education classes organized by public health centers, as well as obstetric outpatient clinics at hospitals in Osaka Prefecture, where study recruitment flyers were distributed and posted on bulletin boards. In addition, participants were recruited using snowball sampling, whereby enrolled participants were asked to invite others to participate in the study.
Adverse events
No occurrence
Outcome measures
Primary outcome:
Knowledge regarding infant crying behavior by Crying Knowledge Scale
Secondary outcomes:
1.Change in knowledge regarding the dangers of shaking infants by Shaking Knowledge Scale
2.Change in salivary amylase activity
3.Subjective evaluation of the VR educational material
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 20 | Day |
Last modified on
| 2025 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044408
