UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048905 |
|---|---|
| Receipt number | R000055523 |
| Scientific Title | Investigation on the effect of wearing a maternity experience jacket on respiratory and circulation |
| Date of disclosure of the study information | 2022/10/30 |
| Last modified on | 2022/09/10 16:56:24 |
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Basic information
Public title
Investigation on the effect of wearing a maternity experience jacket on respiratory and circulation
Acronym
Investigation on the effect of wearing a maternity experience jacket on respiratory and circulation
Scientific Title
Investigation on the effect of wearing a maternity experience jacket on respiratory and circulation
Scientific Title:Acronym
Investigation on the effect of wearing a maternity experience jacket on respiratory and circulation
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of wearing a jacket on pregnant women on respiratory and circulatory dynamics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VE, RR, HR, dyspnea, Fatigue from wearing a jacket for pregnant women
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Walking wearing a pregnant woman jacket
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy adult
Key exclusion criteria
Internal medicine disease, orthopedic disease
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Mamiko |
| Middle name | |
| Last name | Kamoshida |
Organization
Hokkaido University of Science
Division name
Faculty of Health Science
Zip code
006-8585
Address
7-Jo 15-4-1 Maeda, Teine, Sapporo, Hokkaido, Japan
TEL
0116887194
kamoshida-m@hus.ac.jp
Public contact
Name of contact person
| 1st name | Mamiko |
| Middle name | |
| Last name | Kamoshida |
Organization
Hokkaido University of Science
Division name
Faculty of Health Science
Zip code
0068585
Address
7-Jo 15-4-1 Maeda, Teine, Sapporo, Hokkaido, Japan
TEL
0116887194
Homepage URL
kamoshida-m@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University of Science
Address
Faculty of Health Science
Tel
0116887194
kamoshida-m@hus.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 30 | 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
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 10 | Day |
Last modified on
| 2022 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055523
