Tokyo, Oct. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063208) titled 'A Pilot Study on the Effects of Digital Mandala (d.M) on the Mind and Body Using Analyses of Frontal Brain Blood Flow (NIRS) and Heart Rate Variability (HRV)' on Oct. 13.

Study Type: Interventional

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

Primary Sponsor: Institute - Naragakuen University

Condition: Condition - Healthy Older Adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study is being conducted under a contract research agreement between Holness Co., Ltd. and this university. The purpose of this study is to investigate, in healthy adults, the acute and cumulative effects of single and repeated use of the d.M (Digital Mandala) app developed by Holness Co., Ltd. on (1) cerebral blood flow dynamics in the prefrontal cortex (changes in oxy-Hb and deoxy-Hb measured by NIRS), (2) autonomic nervous system activity (heart rate variability), (3) subjective mood and stress levels, compared to a control condition. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The intervention consists of viewing the digital mandala (d.M) app for 15 minutes. The image is generated by superimposing two Archimedean spirals. We believe that these mathematically defined curves, when combined as waves carrying information, have a soothing effect on the viewer's vision. Interventions/Control_2 - As a control, participants will listen to general relaxation music (such as ambient sounds or piano music-existing content that does not include elements of meditation) for 15 minutes.

Eligibility: Age-lower limit - 60 years-old = Gender - Male and Female Key inclusion criteria - Healthy adults aged 60 or older but under 75 (with the male-to-female ratio adjusted to be roughly equal). Individuals who have received an explanation of the study and have voluntarily provided written consent to participate. Individuals who own a smartphone or tablet and are able to operate it at home. Individuals who are able to visit the study site and use the app during the study period. Key exclusion criteria - Individuals with a current history of mental illness (such as schizophrenia, bipolar disorder, or severe depression) or who are currently undergoing treatment for such conditions. Individuals with a history of epilepsy or a family history of epilepsy. Individuals currently undergoing treatment for arrhythmia or heart disease. Individuals who regularly take medications that affect the autonomic or central nervous systems. Experienced practitioners of meditation or mindfulness (those with at least one year of practice, totaling 10 or more hours per month). To avoid the ceiling effect. Individuals with trauma, skin conditions, surgical scars, etc., on the forehead that make it difficult to securely attach the NIRS optical probe. Individuals for whom it is determined that ensuring signal quality for frontal NIRS measurements is difficult due to the condition of their hair (e.g., a large amount of dark hair covering the forehead). Employees of Holness Co., Ltd. and their family members (to avoid conflicts of interest). Individuals who have routinely used d.M or similar products in the past. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 13 Day Anticipated trial start date - 2026 Year 11 Month 16 Day Last follow-up date - 2027 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072343

Disclaimer: Curated by HT Syndication.