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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018737
Receipt No. 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

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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
Obsterics 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
Email 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/
Email nakamura@yokohama-cu.ac.jp

Sponsor
Institute Sachiyo Nakamura
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021677

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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