UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018737 |
|---|---|
| Receipt number | R000021677 |
| Scientific Title | Verification by randomized controlled trial of the effectiveness of the Hiesho (sensitivity to cold) Improvement Pack, a highly sustainable self-care program for pregnant women |
| Date of disclosure of the study information | 2015/08/20 |
| Last modified on | 2017/02/20 16:09:35 |
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Basic information
Public title
Verification by randomized controlled trial of the effectiveness of the Hiesho (sensitivity to cold) Improvement Pack, a highly sustainable self-care program for pregnant women
Acronym
Randomized controlled trials on a group treated with the Hiesho Improvement Pack for hiesho in pregnant women and a group not treated with it.
Scientific Title
Verification by randomized controlled trial of the effectiveness of the Hiesho (sensitivity to cold) Improvement Pack, a highly sustainable self-care program for pregnant women
Scientific Title:Acronym
Randomized controlled trials on a group treated with the Hiesho Improvement Pack for hiesho in pregnant women and a group not treated with it.
Region
| Japan |
Condition
Condition
Low-risk pregnant women experiencing hiesho
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For pregnant women with hiesho who have normal pregnancies, create a Hiesho Improvement Pack for home use, a highly sustainable self-care program to alleviate hiesho, which induces abnormal delivery, and evaluate the Packs effectiveness in relieving hiesho
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
In the intervention group, peripheral temperature is significantly higher compared to the control group (p<0.05).
Key secondary outcomes
In the intervention group, experiencing hiesho drops significantly after intervention (p<0.05).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention period: For 4 weeks
Description of intervention:
Intervention group: 1) wear leg warmers, 2) do exercises for pregnant women, and 3) practice self-care at home by applying pressure to pressure points on the soles of the feet
Interventions/Control_2
Control group: normal daily life
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
Female
Key inclusion criteria
1) Women in the 28th to 33rd weeks of pregnancy, 2) women experiencing hiesho, and 3) low-risk pregnancies
Key exclusion criteria
Women other than 1), 2) and 3) above
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sachiyo Nakamura |
Organization
Yokohama City University
Division name
School of Medicine Nursing Course
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan
TEL
045-787-2786
nakamura@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachiyo Nakamura |
Organization
Yokohama City University
Division name
School of Medicine Nursing Course
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan
TEL
045-787-2786
Homepage URL
http://plaza.umin.ac.jp/hiesho/
nakamura@yokohama-cu.ac.jp
Sponsor or person
Institute
Sachiyo Nakamura
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://online.liebertpub.com/doi/10.1089/acm.2016.0030
Number of participants that the trial has enrolled
Results
Results
Findings for 140 pregnant women, 73 in the experimental group and 67 in the control group, were analyzed. Participants 'body temperatures were measured after completion of the program for four weeks and compared to their temperatures before starting the program. Compared to the control group, arm skin temperature was 3.0doC (p<0.001) higher and leg skin temperature 1.93doC (p=0.02) higher among the experimental group, significantly higher compared to the control group.
Conclusion
The Home Care Package Program for Relieving Hiesho self-care program relieves hiesho to a significant degree.
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
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 20 | Day |
Last modified on
| 2017 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021677
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
