UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048209 |
|---|---|
| Receipt number | R000054920 |
| Scientific Title | Physiological Investigation of Parent-Child Attachment Formation |
| Date of disclosure of the study information | 2022/06/30 |
| Last modified on | 2023/12/13 11:40:49 |
* 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
Physiological Investigation of Parent-Child Attachment Formation
Acronym
Physiological Investigation of Parent-Child Attachment Formation
Scientific Title
Physiological Investigation of Parent-Child Attachment Formation
Scientific Title:Acronym
Physiological Investigation of Parent-Child Attachment Formation
Region
| Japan |
Condition
Condition
able-bodied person
Classification by specialty
| Nursing | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to evaluate parent-child attachment formation and attachment care methods, this study will examine the effects of baby massage on parent-child attachment formation by observing changes in electrocardiograms and salivary oxytocin and salivary cortisol concentrations over time. The main focus of the study is to construct a model for objectively evaluating parent-child attachment formation.
Basic objectives2
Others
Basic objectives -Others
Baby massage is believed to promote the bond between parents and children, and we believe that by examining the effect of baby massage on promoting attachment using an objective evaluation method, we can capture positive changes in parent-child attachment and begin to conduct research that will contribute to future interventions and treatments for parent-child attachment formation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Construct a model for objectively evaluating parent-child attachment formation.
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
Self control
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
Parents give baby massage to their children.
About 30 minutes.
Performed once.
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
| 5 | months-old | <= |
Age-upper limit
| 7 | months-old | > |
Gender
Male and Female
Key inclusion criteria
(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.
Key exclusion criteria
(1)Severe psychiatric symptoms (severe cognitive dysfunction, severe depression).
(2)The child has a severe skin disease.
(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 | Yasuka |
| Middle name | |
| Last name | Nakamura |
Organization
Tohoku University
Division name
Women's Health Nursing & Midwifery, Graduate School of Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7915
nakamurayasuka@nursing.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yasuka |
| Middle name | |
| Last name | Nakamura |
Organization
Tohoku University
Division name
Women's Health Nursing & Midwifery, Graduate School of Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7915
Homepage URL
nakamurayasuka@nursing.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Fam's Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
022-717-8007
med-kenkyo@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
| 2022 | Year | 06 | Month | 30 | 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
| 2022 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054920
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
