UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055450 |
|---|---|
| Receipt number | R000063362 |
| Scientific Title | Creating specific support methods for families of preterm infants who have experienced NICU hospitalization, applying the principles of user-led research |
| Date of disclosure of the study information | 2024/09/07 |
| Last modified on | 2024/09/07 11:38:18 |
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Basic information
Public title
A Study on the Effectiveness of a User-led Research Workshop for Families of Premature Infants Who Experienced NICU Hospitalization
Acronym
Effect of User-led Research Workshops for Families of Preterm Infants
Scientific Title
Creating specific support methods for families of preterm infants who have experienced NICU hospitalization, applying the principles of user-led research
Scientific Title:Acronym
Effect of User-led Research Workshops for Families of Preterm Infants
Region
| Japan |
Condition
Condition
Families who have experienced their child's hospitalization in NICU.
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effectiveness of a user-led research program targeting families of preterm infants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PTG(Post-Traumatic Growth) scores assessed pre-intervention, post-intervention, and one month post-intervention.
Key secondary outcomes
The Revised Impact of Event Scale, the WCCL Coping Scale, and the Two-Dimensional Mood Scale.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Behavior,custom |
Interventions/Control_1
Three 120-minute online sessions, applying the principles of user-led research, will be conducted approximately once a week.
Interventions/Control_2
A one-month non-intervention period is established, and equivalent sessions will be held afterward.
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
Families who have experienced the NICU hospitalization of a child due to preterm birth.
Key exclusion criteria
Families who have experienced their child's hospitalization in NICU for reasons other than preterm birth.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Midori |
| Middle name | |
| Last name | Habutsu |
Organization
Graduate School of Tokyo Seitoku University
Division name
Department of Psychology
Zip code
114-0033
Address
1-7-13, Jujodai, Kita-ku, Tokyo, JAPAN
TEL
03-3908-4530
22dc03@st.tsu.ac.jp
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Kikuchi |
Organization
Graduate School of Tokyo Seitoku University
Division name
Department of Psychology
Zip code
114-0033
Address
1-7-13, Jujodai, Kita-ku, Tokyo, JAPAN
TEL
03-3908-4530
Homepage URL
h-kikuchi@tsu.ac.jp
Sponsor or person
Institute
Tokyo Seitoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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 | 07 | 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
| 2024 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 09 | 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 | 07 | Day |
Last modified on
| 2024 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063362
