UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056823 |
|---|---|
| Receipt number | R000064776 |
| Scientific Title | Elucidation of the Mechanism of Synchronization of Heart Rate Variability in the Process of Parent-Child Attachment Format |
| Date of disclosure of the study information | 2025/01/27 |
| Last modified on | 2025/07/31 11:55:42 |
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Basic information
Public title
Elucidation of the Mechanism of Synchronization of Heart Rate Variability in the Process of Parent-Child Attachment Format
Acronym
Elucidation of the Mechanism of Synchronization of Heart Rate Variability in the Process of Parent-Child Attachment Format
Scientific Title
Elucidation of the Mechanism of Synchronization of Heart Rate Variability in the Process of Parent-Child Attachment Format
Scientific Title:Acronym
Elucidation of the Mechanism of Synchronization of Heart Rate Variability in the Process of Parent-Child Attachment Format
Region
| Japan |
Condition
Condition
able-bodied person
Classification by specialty
| Nursing | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been reported that the phenomenon of synchronization of parent-child heart rate variability occurs during the attachment formation process between parents and children. The applicants have developed an analytical method to quantify this phenomenon. The purpose of this study is to elucidate the detailed mechanism of the occurrence of the synchronization phenomenon of heart rate variability between parents and children by using this analytical method. To this end, a questionnaire survey and behavioral observation technique will be used to analyze whether numerical differences in heart rate variability can be observed depending on parental background, and whether differences in this phenomenon can also be observed in caregivers other than parents.
Basic objectives2
Others
Basic objectives -Others
The significance of this research lies in the fact that it enables us to understand the development of the parent-child relationship as concrete data, and aims at the early detection of attachment dysformation based on scientific evidence.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Elucidate the mechanism of the synchronization phenomenon of heart rate variability between parents and children
Key secondary outcomes
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Parents and children play freely.
About 5 minutes.
ECG measurements are taken during this time.
Interventions/Control_2
Child plays freely with a third party other than the parent.
About 5 minutes.
During this time, an electrocardiogram will be measured.
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
| 5 | months-old | <= |
Age-upper limit
| 7 | months-old | > |
Gender
Male and Female
Key inclusion criteria
[Parents and children]
(1) Parents must be at least 20 years of age (at the time consent is obtained) and the child must be between 5 and 7 months of age.
(2)The child must be in full term (37 weeks 0 days to 41 weeks 6 days).
(3) Mother and child (one) or father and child (one) must be able to participate.
(4)The child's gender is not required.
(5)The substitute for the child must be a parent.
(6)The applicant must be able to communicate in Japanese and give written consent in Japanese.
[Third parties other than parents]
(1) Age must be 20 years or older (at the time of consent).
(2) The gender of the child must be the same as that of the intended parent.
(3)Have no experience in child care themselves (no professional experience with children over an extended period of time).
(4)Have a professional education related to nursing or childcare (including undergraduates who have completed maternal/pediatric training).
(5)The applicant must be able to communicate in Japanese and give written consent in Japanese.
Key exclusion criteria
[Parents and children]
(1)Severe psychiatric symptoms (severe cognitive dysfunction, severe depression).
(2)Severe skin diseases.
(3)Other cases in which the physician and midwife or nurse deem it inappropriate for the child to participate in the survey.
[Third parties other than parents]
(1)Severe psychiatric symptoms (severe cognitive dysfunction, severe depression).
(2)Severe skin diseases.
(3)Other cases in which the physician and midwife or nurse deem it inappropriate for the child to participate in the survey.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Siwaku |
Organization
Tohoku University
Division name
Graduate School of Medicine, Postgraduate Course of Health Sciences, Department of Child Health Nursing
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7921
hsiwaku@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Aoi |
| Middle name | |
| Last name | Sakurai |
Organization
Tohoku University
Division name
Graduate School of Medicine, Department of Child Health Nursing
Zip code
980-8574
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7921
Homepage URL
aoi.sakurai.tohokumed@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
ec-med@grp.tohoku.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 | 01 | Month | 27 | 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
Suspended
Date of protocol fixation
| 2025 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | 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 | 01 | Month | 27 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064776
