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A Study on the Effects of Functional Leg Warmers on Hiesho(cold disorder) in Pregnant Women

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 - Perinatal Minor Complaints Thermal Leg Warmers Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061340
Enrollment
80
Registered
2026-04-21
Start date
2025-12-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiesho(cold disorder)

Interventions

Wearing acupoint-targeted thermogenic fiber pile-knit leg warmers Usual care (usual lifestyle)

Sponsors

Kansai University of Health Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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.

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactNao Okamoto

Kansai University of Health Sciences Graduate School

okamoto@kansai.ac.jp0724538251

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026