UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034772 |
|---|---|
| Receipt number | R000039451 |
| Scientific Title | 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 15:32:57 |
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Basic information
Public title
The influence of mother's paced breathing on infant heart rate variability
Acronym
The influence of mother's paced breathing on infant heart rate variability
Scientific Title
The influence of mother's paced breathing on infant heart rate variability
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Ayami Suga |
Organization
Unicharm Corporation
Division name
Convivial Society Lab.
Zip code
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 | |
| Middle name | |
| Last name | Ayami Suga |
Organization
Unicharm Corporation
Division name
Convivial Society Lab.
Zip code
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
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
The effects of the maternal cardiac activity on the infant's heart rate variability were age-dependent.
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
| 2015 | Year | 08 | Month | 07 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039451
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
