UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052676 |
|---|---|
| Receipt number | R000059962 |
| Scientific Title | Evaluation of Psychophysiological Effects Induced by Radiant Heat Systems |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2023/11/06 08:40:07 |
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Basic information
Public title
Evaluation of Psychophysiological Effects Induced by Radiant Heat Systems
Acronym
Evaluation of Psychophysiological Effects Induced by Radiant Heat Systems
Scientific Title
Evaluation of Psychophysiological Effects Induced by Radiant Heat Systems
Scientific Title:Acronym
Evaluation of Psychophysiological Effects Induced by Radiant Heat Systems
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of the Radiant Heat System (ENRICH) on psychological states and physiological responses, and to collect objective data representing its impact and efficacy on the mind and body.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pupillary light reflex
Skin temperature (fingertips and forehead)
Electrocardiogram (ECG)
Vascular age
Flicker value
Brain age
Stress Checklist 30-item (SCL30)
Visual Analog Scale (VAS)
Multiple mood scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Staying in a room with the Radiant Heat System (ENRICH) for 15 minutes.
Interventions/Control_2
Staying in an adjacent room with controlled temperature and humidity 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy males and females aged 20 and older.
2. Subjects who can give informed consent to partake in this research, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects with a smoking habit.
2. Subjects who are cold-sensitive constitution (including subjects like that who feel cold on their hands and foots even in summer).
3. Subjects diagnosed with any disease and receiving drug treatments (e.g., antihypertensive drugs, antiepileptic drugs) at the time of consent.
4. Subjects who have taken or applied drugs for disease treatment in the past month (excluding cold remedies but including treatments for hay fever).
5. Subjects who underwent surgery on the measurement areas (chest, face, fingertips) within the past 6 months.
6. Subjects currently participating in another clinical trial or those who have participated in a clinical trial within the past month.
7. Subjects with issues regarding electrocardiogram measurements (e.g., dense chest hair, pacemaker users).
8. Subjects with previous and/or current medical history of serious diseases in liver, kidney, heart, lung, blood.
9. Pregnant or lactating Subjects or those with the possibility of pregnancy.
10 Subjects with dermatological conditions such as atopic dermatitis.
11 Subjects experiencing pain in the knee or discomfort when bending the knee.
12. Subjects deemed unsuitable for participation in the trial by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Aiko |
| Middle name | |
| Last name | Ueda |
Organization
P&C PLANNING CO., LTD.
Division name
CEO
Zip code
810-0001
Address
2-3-10 Tenjin, Chuo-ku fukuoka-shi, Fukuoka 8100001 JAPAN
TEL
092-725-6623
info@8p-ch.com
Public contact
Name of contact person
| 1st name | Aiko |
| Middle name | |
| Last name | Ueda |
Organization
P&C PLANNING CO., LTD.
Division name
CEO
Zip code
810-0001
Address
2-3-10 Tenjin, Chuo-ku fukuoka-shi, Fukuoka 8100001 JAPAN
TEL
092-725-6623
Homepage URL
info@8p-ch.com
Sponsor or person
Institute
P&C PLANNING CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
P&C PLANNING CO., LTD.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059962
