UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041822