Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058376) titled 'Reliability and validity of the Japanese version of the modified Yale Preoperative Anxiety Scale (mYPAS) in children aged 2-12 years' on Aug. 1.

Study Type: Observational

Primary Sponsor: Institute - Juntendo University

Condition: Condition - Pediatric patient scheduled for surgery under general anesthesia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to evaluate the reliability and validity of the Japanese version of the modified Yale Preoperative Anxiety Scale (J-mYPAS), including children aged 2 to 4 years who were not assessed in previous studies. In addition, to address the limitation of prior single-center research, this study will conduct the same evaluation at a different institution to assess the broader clinical applicability of the J-mYPAS Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 2 years-old = Gender - Male and Female Key inclusion criteria - 1. Patients undergoing surgery under general anesthesia (pediatric surgery) at our hospital. 2. Patients classified as ASA Physical Status 1 or 2 according to the American Society of Anesthesiologist. 3. Patients whose legal guardians have received a full explanation of the study, fully understood it, and provided written informed consent voluntarily. Key exclusion criteria - 1. Non-native Japanese-speaking patients or their surrogates 2. Patients with mental/developmental retardation or neurological disorders 3. Emergency surgery cases 4. Patients whose surrogate refuses to participate in this study 5. Patients who are deemed inappropriate for participation by the principal investigator Target Size - 110

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 06 Month 01 Day Date of IRB - 2025 Year 07 Month 03 Day Anticipated trial start date - 2025 Year 08 Month 01 Day Last follow-up date - 2029 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066740

Disclaimer: Curated by HT Syndication.