UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047796 |
|---|---|
| Receipt number | R000054486 |
| Scientific Title | Effects of mental stress on blood pressure |
| Date of disclosure of the study information | 2022/05/20 |
| Last modified on | 2023/09/05 19:00:22 |
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Basic information
Public title
Effects of mental stress on blood pressure
Acronym
Effects of mental stress
Scientific Title
Effects of mental stress on blood pressure
Scientific Title:Acronym
Effects of mental stress
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of acute mental stress on brachial blood pressure.
Basic objectives2
Others
Basic objectives -Others
To examine the effects of acute mental stress on ankle blood pressure.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brachial blood pressure (after 5- and 30-min)
Ankle blood pressure (after 5- and 30-min)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mental stress. Each participant are asked to serially subtract 13 from a 3-digit number (close to 1,000) as quickly and accurately as possible within 5 min.
Interventions/Control_2
Control. Participants are instructed to slowly count upward, starting from 1, for 5 min.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
18 years and older men and women, not restrict ed by a doctor from exercising, not have medic ation and smoking.
Key exclusion criteria
Have a cardiovascular and cerebrovascular diseases.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kume |
| Middle name | |
| Last name | Daisuk |
Organization
Osaka Institute of Technology
Division name
Faculty of Information Science and Technology
Zip code
573-0196
Address
1-79-1 Kitayama, Hirakata, Osaka
TEL
072-866-5368
daisuke.kume@oit.ac.jp
Public contact
Name of contact person
| 1st name | Kume |
| Middle name | |
| Last name | Daisuk |
Organization
Osaka Institute of Technology
Division name
Faculty of Information Science and Technology
Zip code
573-0196
Address
1-79-1 Kitayama, Hirakata, Osaka
TEL
072-866-5368
Homepage URL
daisuke.kume@oit.ac.jp
Sponsor or person
Institute
Osaka Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid from the Japanese Ministry of Education, Culture, Sports, Science, and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Human Ethics Committee at the Osaka Insti tute of Technology
Address
5-16-1 Ohmiya, Asahi-ku, Osaka
Tel
06-4300-6883
Kenkyu@josho.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://bmcresnotes.biomedcentral.com/articles/10.1186/s13104-022-06160-7
Number of participants that the trial has enrolled
56
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 07 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2022 | Year | 05 | Month | 18 | Day |
Last modified on
| 2023 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054486
