Tokyo, April 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061368) titled 'Study on the effect of different evaluation environments on subjective evaluation scores and elucidation of its factors' on April 27.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Macromill, Inc.

Condition: Condition - Healthy subjects Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To investigate the impact of differences in evaluation environments (face-to-face vs. fully online) on data variability in subjective evaluations in clinical trials. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Online evaluation environment: Answering questionnaires in a non-supervised environment such as at home. Interventions/Control_2 - Face-to-face evaluation environment: Answering questionnaires under supervision at a designated venue.

Eligibility: Age-lower limit - 30 years-old

Gender - Male and Female Key inclusion criteria - (1) Men and women aged 30 to 59 years at the time of providing informed consent. (2) Individuals who feel a certain amount of stress in their daily lives. (3) Individuals who have received a full explanation of the purpose and content of the study, have the capacity to provide consent, can understand the content well, and provide their own consent via electronic informed consent. Key exclusion criteria - (1) Individuals receiving medical treatment, medication, or counseling by a physician for psychiatric disorders such as depression, anxiety, insomnia, or panic disorder. (2) Individuals currently receiving medical treatment or medication by a physician for a serious chronic disease. (3) Individuals with a serious medical history of cerebrovascular, cardiac, hepatic, renal, hematologic, or endocrine disease. (4) Heavy drinkers. (5) Individuals who do not have a communication/private room environment at home where they can quietly respond to questionnaires. (6) Individuals with extremely irregular sleeping or eating habits. (7) Individuals whose living environment, dietary habits, or exercise habits may change significantly during the study period. (8) Women who are pregnant, may be pregnant, or intend to become pregnant during the study period. Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 10 Day Date of IRB - 2026 Year 04 Month 17 Day Anticipated trial start date - 2026 Year 04 Month 27 Day Last follow-up date - 2026 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070215

Disclaimer: Curated by HT Syndication.