UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The influence of mother's paced breathing on infant heart rate variability
Title of the study (Brief title)	The influence of mother's paced breathing on infant heart rate variability
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to investigate whether the infant's heart rate variability increases by mother's paced breathing.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Heart rate variability
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	The test is conducted twice per person, devided into two days. Mothers breathed at a rate of 6 cycles per minute (cpm) for 15 min. A control condition was established on alternate days, with mothers breathing at a normal rate. A crossover design was adopted in which all the dyads participated in both a paced-breathing session and a natural-breathing session on separate days. The order of the breathing conditions was performed from paced-breathing to natural-breathing.
Interventions/Control_2	The test is conducted twice per person, devided into two days. The order of the breathing conditions was performed from natural-breathing to paced-breathing.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy mother and infant. (Infants aged 3 to 8 months)
Key exclusion criteria	None
Target sample size	80

Research contact person
Name of lead principal investigator	Ayami Suga
Organization	Unicharm Corporation
Division name	Convivial Society Lab.
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	Ayami Suga
Organization	Unicharm Corporation
Division name	Convivial Society Lab.
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	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Psychology, Nagoya University
Name of secondary funｄer(s)

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	2018 Year 11 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 07 Day
Anticipated trial start date	2015 Year 08 Month 11 Day
Last follow-up date	2016 Year 02 Month 29 Day
Date of closure to data entry	2016 Year 02 Month 29 Day
Date trial data considered complete	2016 Year 02 Month 29 Day
Date analysis concluded	2018 Year 04 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	The effects of the maternal cardiac activity on the infant's heart rate variability were age-dependent.
Other related information

Management information
Registered date	2018 Year 11 Month 05 Day
Last modified on	2018 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039451