UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063208 |
|---|---|
| Receipt number | R000072343 |
| Scientific Title | An Exploratory Study on the Effects of Holness Co., Ltd.'s Digital Mandala (d.M) on the Mind and Body: A Pilot Study Using Analysis of Frontal Brain Blood Flow (NIRS) and Heart Rate Variability (HRV) |
| Date of disclosure of the study information | 2026/10/13 |
| Last modified on | 2026/10/07 18:13:07 |
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Basic information
Public title
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)
Acronym
Digital Mandala Pilot Test
Scientific Title
An Exploratory Study on the Effects of Holness Co., Ltd.'s Digital Mandala (d.M) on the Mind and Body: A Pilot Study Using Analysis of Frontal Brain Blood Flow (NIRS) and Heart Rate Variability (HRV)
Scientific Title:Acronym
A Pilot Study on the Effects of Digital Mandala (d.M) on the Mind and Body
Region
| Japan |
Condition
Condition
Healthy Older Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in oxygenated hemoglobin (oxy-Hb) concentration based on NIRS data analysis: As a primary indicator, calculate the change from the baseline for each channel. Change in deoxygenated hemoglobin (deoxy-Hb) concentration: Calculated as a supplementary indicator. Change in total hemoglobin (total-Hb = oxy-Hb + deoxy-Hb) concentration.
Key secondary outcomes
In accordance with the Standard Guidelines for Heart Rate Variability Analysis (Task Force of the European Society of Cardiology, 1996): time domain, frequency domain (MEM method), coefficient of variation (CCV), and heart rate.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 75 | 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 sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Morihiro |
| Middle name | |
| Last name | Tsujishita |
Organization
Naragakuen University
Division name
Department of Rehabilitation, School of Health and Medical Sciences
Zip code
6310003
Address
15-1, Nakatomigaoka 3-chome, Nara City
TEL
09094171234
tuzisita@nara-su.ac.jp
Public contact
Name of contact person
| 1st name | Morihiro |
| Middle name | |
| Last name | Tsujishita |
Organization
Naragakuen University
Division name
Department of Rehabilitation, Faculty of Health Sciences
Zip code
6310003
Address
3-15-1, nakatomigaoka,Nara
TEL
09094171234
Homepage URL
tuzisita@nara-su.ac.jp
Sponsor or person
Institute
Naragakuen University
Institute
Department
Personal name
Funding Source
Organization
Wholeness, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Committee, Faculty of Health and Medical Sciences, Nara Gakuen University
Address
3-15-1, nakatomigaoka,Nara
Tel
909417123
tuzisita@nara-su.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
奈良学園大学
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 07 | Day |
Last modified on
| 2026 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072343
