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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036708
Receipt No. 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 2019/05/14

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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
Email 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
Email ayami-suga@unicharm.com

Sponsor
Institute Unicharm Corporation
Institute
Department

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
Email 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 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
2019 Year 04 Month 22 Day
Date of IRB
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 10 Day
Last modified on
2019 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041822

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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