UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Sachiyo Nakamura
Organization	Yokohama City University
Division name	School of Medicine Nursing Course
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	Sachiyo Nakamura
Organization	Yokohama City University
Division name	School of Medicine Nursing Course
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://online.liebertpub.com/doi/10.1089/acm.2016.0030
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.
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/icdr_e/ctr_view.cgi?recptno=R000021677