Tokyo, Aug. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062450) titled 'A Study of the Physical and Psychological Effects of Warm Hand Bathing in Patients With Depression' on Aug. 4.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Josai International University
Condition:
Condition - Depressive disorders
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to determine the immediate effects of a 5-minute warm hand-bath intervention using water at 39 degrees C on autonomic nervous activity and prefrontal hemodynamics in patients with depressive disorders. Changes in skin temperature and subjective mood states before and after the intervention will also be evaluated.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Each participant will receive a single 5 minute warm hand bath. Both hands and forearms will be immersed up to the radial styloid level in water maintained at 39 degrees C. Participants will rest for 2 minutes before and 3 minutes after the intervention.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Inpatients aged 18 years or older in the psychiatric ward of Asahi General Hospital
Individuals who hold a Mental Disability Certificate at Grade 2 or Grade 3
Individuals who have the capacity to make an independent decision regarding study participation
Individuals judged by the attending psychiatrist to be able to participate in the study
Individuals who receive a written explanation of the study and voluntarily provide written informed consent
Key exclusion criteria - Patients with severe acute psychiatric symptoms who are unable to remain at rest or cooperate with the measurements, as judged by the attending psychiatrist
Patients with severe physical conditions for whom thermal stimulation cannot be safely performed, including severe cardiac disease or peripheral circulatory disorders
Patients with infection, injury, eczema, or other skin lesions on the forearms that make hand bathing inappropriate
Patients expected to have severe anxiety or agitation that would make it difficult to tolerate the equipment or study procedures
Patients judged ineligible by the attending psychiatrist or the principal investigator
Target Size - 25
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 05 Month 29 Day
Date of IRB - 2026 Year 05 Month 29 Day
Anticipated trial start date - 2026 Year 05 Month 29 Day
Last follow-up date - 2028 Year 04 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071475
Disclaimer: Curated by HT Syndication.