UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036708 |
|---|---|
| Receipt number | R000041822 |
| Scientific Title | Examination of the interaction between the physiology and psychology of a mother and infant by using an experience sampling method |
| Date of disclosure of the study information | 2019/05/15 |
| Last modified on | 2020/05/11 14:29:35 |
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Basic information
Public title
Examination of the interaction between the physiology and psychology of a mother and infant by using an experience sampling method
Acronym
Examination of the interaction between the physiology and psychology of a mother and infant
Scientific Title
Examination of the interaction between the physiology and psychology of a mother and infant by using an experience sampling method
Scientific Title:Acronym
Examination of the interaction between the physiology and psychology of a mother and infant
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of music intervention during diaper change on the mother-infant heart rate and emotions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mother's heart rate variability
Infant's heart rate
Key secondary outcomes
Variability in subjective emotions during heart rate measurement when changing diapers.
Psychological scales (Edinburgh Postnatal Depression Scale, Parenting Self-Efficacy Scale, State-Trait Anxiety Inventory, Multidimensional Assessment of Interoceptive Awareness, Perceived Stress Scale, Disgust Propensity and Sensitivity Scale-Revised)
Infant development 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
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Control 1
There is no intervention, and the questionnaire regarding psychological indicators and development is administered three times.
1. The first questionnaire is administered.
2. The second questionnaire is administered after one month.
3. The third questionnaire is administered after three months.
Interventions/Control_2
Control 2
There is no musical intervention, and the exclusive use of a smartphone application records the mother-infant heart rate (HR) measurement and emotions for one month.
A questionnaire on psychological indicators and development is administered three times.
1. The first questionnaire is administered.
2. HR measurements and emotions are recorded via smartphone for one month.
3. The second questionnaire is administered after one month.
4. The third questionnaire is administered after three months.
Interventions/Control_3
Intervention
One-month recording of the mother-infant HR measurements and emotions through the exclusive use of a smartphone application.
Listen to music when changing diapers one to three times per day.
A questionnaire concerning psychological indicators and development is answered three times.
1. The first questionnaire is administered.
2. Diaper exchange is performed using HR measurements and recording record emotions and music via smartphone for one month.
3. The second questionnaire is administered after one month.
4. The third questionnaire is administered after three months.
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
Healthy mother and infant. (Infants aged three to eight months)
Unemployed mother
First child
Key exclusion criteria
None
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Ayami |
| Middle name | |
| Last name | Suga |
Organization
Unicharm Corporation
Division name
Kyo-sei Shakai (Convivial Society)Lab.
Zip code
769-1602
Address
1531-7, Wadahama Toyohama-cho, Kanonji-shi, Kagawa, 769-1602, Japan
TEL
0875-52-6930
ayami-suga@unicharm.com
Public contact
Name of contact person
| 1st name | Ayami |
| Middle name | |
| Last name | Suga |
Organization
Unicharm Corporation
Division name
Kyo-sei Shakai (Convivial Society)Lab.
Zip code
769-1602
Address
1531-7, Wadahama Toyohama-cho, Kanonji-shi, Kagawa, 769-1602, Japan
TEL
0875-52-6930
Homepage URL
ayami-suga@unicharm.com
Sponsor or person
Institute
Unicharm Corporation
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Psychology, Nagoya University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Psychology, Nagoya University
Address
Furo-cho, Chikusa-ku, Nagoya, 464-8601, Japan
Tel
052-789-2221
iritani.keiko@gmail.com
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
ユニ・チャーム株式会社
Unicharm Corporation
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://society-for-affective-science.org/list-of-sas-virtual-posters-2020/
Number of participants that the trial has enrolled
153
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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 22 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 22 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 10 | Day |
Last modified on
| 2020 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041822
