Tokyo, Feb. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060609) titled 'Exploratory Study of Sweat Analysis for Evaluating Stress and Fatigue Associated with Driving Work' on Feb. 10.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - TANAKA PRECIOUS METAL GROUP Co., Ltd.
Condition:
Condition - Healthy adults (workers engaged in driving work)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To explore the association between changes in sweat components and subjective stress/fatigue in healthy adults engaged in driving work by analyzing inorganic and organic components in sweat samples collected before and after work and after music listening. In addition, to obtain reference information for interpreting changes in sweat components by collecting stress-related indicators such as a psychological questionnaire (TDMS-ST) and salivary amylase measurements.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Single-arm intervention. After the post-work assessment, participants listen to one track of relaxation/healing music for approximately 5-8 minutes in a seated position in a quiet room, followed by an immediate post-listening assessment. This procedure is repeated for 3days for each participant. Recording: one self-selected track from a 10-track album, Mental Health Music for Working People by Toshiki Kato.
Eligibility:
Age-lower limit - 30
years-old
Gender - Male and Female
Key inclusion criteria - Aged 30 to 69 years
Drives a vehicle routinely and can provide driving time and travel distance information
Is aware of feeling stress in daily life and recognizes the need for improvement
Agrees to participate in the music-listening task (no strong aversion to music)
No history of psychiatric disorders or serious diseases
Not pregnant or breastfeeding, and not planning pregnancy
Does not perceive having a condition with very low sweating (e.g., extremely dry skin)
Key exclusion criteria - Currently participating in another clinical trial or participated within the past 4 weeks.
Target Size - 15
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 10 Day
Anticipated trial start date - 2026 Year 02 Month 16 Day
Last follow-up date - 2027 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069326
Disclaimer: Curated by HT Syndication.