UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061340 |
|---|---|
| Receipt number | R000068576 |
| Scientific Title | Effects of Wearing Leg Warmers with Acupoint-Targeted Thermogenic Fiber Pile Knit Fabric in Pregnant Women with Hiesho(cold disorder): A Randomized Controlled Trial for Minor Discomforts During the Perinatal Period |
| Date of disclosure of the study information | 2026/04/21 |
| Last modified on | 2026/04/21 17:28:34 |
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Basic information
Public title
A Study on the Effects of Functional Leg Warmers on Hiesho(cold disorder) in Pregnant Women
Acronym
Leg Warmer Study for Hiesho(cold disorder) in Pregnant Women
Scientific Title
Effects of Wearing Leg Warmers with Acupoint-Targeted Thermogenic Fiber Pile Knit Fabric in Pregnant Women with Hiesho(cold disorder): A Randomized Controlled Trial for Minor Discomforts During the Perinatal Period
Scientific Title:Acronym
Perinatal Minor Complaints Thermal Leg Warmers Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Hiesho(cold disorder)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This randomized controlled trial will evaluate whether wearing acupoint-targeted thermogenic fiber pile-knit leg warmers, compared with lifestyle guidance alone, alleviates minor complaints during pregnancy and postpartum and reduces the risk of postpartum depression in pregnant women with hiesho(cold disorder).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalence of minor complaints will be assessed using the 29 minor-trouble symptoms identified by Shinkawa (2020). Measurement time points are as follows: 1) at receipt of the leg warmers; 2) at approximately 32 weeks gestation (1 month after initiation of wear); 3) postpartum: the day before hospital discharge and at the 2-week postnatal check-up.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Wearing acupoint-targeted thermogenic fiber pile-knit leg warmers
Interventions/Control_2
Usual care (usual lifestyle)
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
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
Pregnant women with uncomplicated singleton pregnancies at >=20 weeks of gestation (when body temperature is relatively stable) and a score of >=4 on the Kusumi-Emori Cold Sensitivity Assessment Scale.
Key exclusion criteria
Pregnant women with comorbidities that may affect pregnancy or body temperature (endocrine disorders, autonomic nervous system disorders, hypertension, cardiac disease, renal disease, or psychiatric disorders).
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shunji |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kansai University of Health Sciences
Division name
Graduate School
Zip code
5900482
Address
2-11-1 Wakaba, Kumatori, Sennan, Osaka, Japan
TEL
0724538409
sakaguti@kansai.ac.jp
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Okamoto |
Organization
Kansai University of Health Sciences
Division name
Graduate School
Zip code
5900482
Address
2-11-1 Wakaba, Kumatori, Sennan, Osaka, Japan
TEL
0724538251
Homepage URL
okamoto@kansai.ac.jp
Sponsor or person
Institute
Kansai University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Kansai University of Health Sciences
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
Kansai University of Health Sciences
Address
2-11-1 Wakaba, Kumatori-cho, Sennan-gun, Osaka, Japan
Tel
0724538251
sakaguti@kansai.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
脇本産婦人科（大阪府）、ENAレディースクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 21 | Day |
Last modified on
| 2026 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068576
