Tokyo, April 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061340) titled 'A Study on the Effects of Functional Leg Warmers on Hiesho(cold disorder) in Pregnant Women' on April 21.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Kansai University of Health Sciences
Condition:
Condition - Hiesho(cold disorder)
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Wearing acupoint-targeted thermogenic fiber pile-knit leg warmers
Interventions/Control_2 - Usual care (usual lifestyle)
Eligibility:
Age-lower limit - 18
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 Size - 80
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068576
Disclaimer: Curated by HT Syndication.
