UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034772
Receipt No. R000039451
Official scientific title of the study The influence of mother's paced breathing on infant heart rate variability
Date of disclosure of the study information 2018/11/05
Last modified on 2018/11/05

* 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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.