Tokyo, Sept. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063006) titled 'Immediate Effects of Hot Spring Bathing on Well-Being-Related Outcomes and Cognitive Alertness: A Pilot Randomized Crossover Trial' on Sept. 24.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Yamagata University
Condition:
Condition - Healthy adult men
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the immediate effects of Zao hot spring bathing on well-being-related outcomes and cognitive alertness in a pilot randomized crossover trial.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - A: Indoor plain hot-water bathing
B: Indoor Zao hot spring bathing
C: Outdoor Zao hot spring bathing
Participants undergo conditions A, B, and C in this order. In each condition, participants bathe for up to 10 minutes, with an interval of at least 7 days between conditions.
Interventions/Control_2 - A: Indoor plain hot-water bathing
B: Indoor Zao hot spring bathing
C: Outdoor Zao hot spring bathing
Participants undergo conditions A, C, and B in this order. In each condition, participants bathe for up to 10 minutes, with an interval of at least 7 days between conditions.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male
Key inclusion criteria - 1. Men aged 20-64 years.
2. Individuals who are able to participate in all three bathing conditions during the study period: an indoor plain hot-water bath (control), an indoor Zao hot 3. spring bath (spring water), and an outdoor Zao hot spring bath (spring water and landscape).
4. Individuals who are able to safely undergo whole-body bathing for 5-10 minutes under each condition.
5. Individuals who are able to understand questions and instructions provided in Japanese and complete psychological questionnaires, simplified electroencephalogram measurements, a reading-aloud task, and a cognitive task.
6. Individuals who are considered eligible for participation in the study by the principal investigator.
Key exclusion criteria - 1. Individuals who have been advised by a physician to restrict bathing or who are considered by the principal investigator to be unable to safely undergo hot spring bathing.
2. Individuals with serious underlying medical conditions, including severe cardiovascular, cerebrovascular, respiratory, or renal disease.
3. Individuals with uncontrolled hypertension (systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg) or other medical conditions that may be aggravated by hot spring bathing.
4. Individuals with epilepsy or other neurological disorders that may interfere with electroencephalogram measurements or cognitive testing.
5. Individuals currently receiving treatment for psychiatric disorders or regularly taking psychotropic medications, hypnotics, anxiolytics, or similar medications.
6. Individuals who are unable to bathe in Zao hot spring because of hypersensitivity to strongly acidic sulfur spring water, skin disorders, or other conditions.
7. Individuals who are considered ineligible for participation in the study by the principal investigator.
Target Size - 12
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 09 Month 17 Day
Date of IRB - 2026 Year 09 Month 17 Day
Anticipated trial start date - 2026 Year 09 Month 18 Day
Last follow-up date - 2026 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072129
Disclaimer: Curated by HT Syndication.
