Tokyo, March 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061006) titled 'Objective Evaluation of Fatigue in Endoscopy Healthcare Providers Using Heart Rate Variability Analysis with Wearable Devices' on March 30.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Mie University Graduate School of Medicine

Condition: Condition - Musculoskeletal Disorders Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To quantitatively assess physiological markers reflecting physical and mental workload during endoscopic procedures using wearable devices. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Participants will wear a wearable device and Holter electrocardiography during endoscopic procedures to continuously measure physiological parameters, including heart rate variability.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Physicians, nurses, or clinical engineers working at our institution 2. Scheduled to be engaged in endoscopic procedures, including colonoscopy, ERCP, EUS-FNA, or ESD 3. Able to wear the measurement devices (wearable device and Holter electrocardiography) for a specified period 4. Provided written informed consent to participate in the study Key exclusion criteria - 1. Individuals with cardiovascular disease or autonomic dysfunction that may affect heart rate variability assessment 2. Individuals who are regularly taking medications that affect heart rate or autonomic nervous system function 3. Individuals for whom wearing the measurement devices is difficult or inappropriate due to skin conditions or allergies Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 11 Day Anticipated trial start date - 2026 Year 03 Month 30 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069810

Disclaimer: Curated by HT Syndication.