UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038884 |
|---|---|
| Receipt number | R000044337 |
| Scientific Title | Effect of human body grounding on psychological and emotional state: an experimental double-blind pragmatic randomized controlled trial |
| Date of disclosure of the study information | 2019/12/14 |
| Last modified on | 2022/06/23 17:00:35 |
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Basic information
Public title
Effect of human body grounding on psychological and emotional state
Acronym
Effect of grounding on psychological and emotional state
Scientific Title
Effect of human body grounding on psychological and emotional state: an experimental double-blind pragmatic randomized controlled trial
Scientific Title:Acronym
Effect of grounding on psychological and emotional state
Region
| Europe |
Condition
Condition
General public
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate presence and degree of influence of grounding (electrical connection to the earth) of the human body on subjective emotional expressions and test the hypothesis of its improvement under the influence of grounding in subjects performing their typical tasks using computer equipment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Positive and Negative Affect Scale, before and after exposure
Key secondary outcomes
1) Visual analogue scale of perceived stress level, before and after exposure
2) Test of Differentiated Self-Assessment of Functional State, before and after exposure
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Grounding a subject's body through a self-adhesive electrode with a layer of conductive gel attached to the subject's lower or upper extremity and connected to the earth through a 100 kohm resistance contained inside a numbered junction box at the subject's workplace while performing their typical tasks using computer equipment for 3 hours.
Interventions/Control_2
Sham grounding a subject's body through a self-adhesive electrode with a layer of conductive gel attached to the subject's lower or upper extremity and connected to the earth through an open circuit (break) contained inside a numbered junction box at the subject's workplace while performing their typical tasks using computer equipment for 3 hours.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Willing and able to give informed consent to participate in the experiment and permission for data use
2) Work activities related to the use of computer equipment
Key exclusion criteria
1) Inability to access their workplace without access modification
2) Inability to remain seated for 3 hours at their workplace without significant discomfort
3) Inability to perform their typical workplace tasks on computer equipment
4) Inability to understand instructions, content of questionnaires, or to provide meaningful answers
5) History of any allergic reaction to self-adhesive electrodes or gel used in them
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Volodymyr |
| Middle name | |
| Last name | Akimenko |
Organization
O. M. Marzieiev Institute of Public Health of the National Academy of Medical Sciences of Ukraine
Division name
Laboratory of Physical Environmental Factors
Zip code
02660
Address
50 Popudrenko Street, Kyiv, Ukraine
TEL
+380-50-625-0771
v_ya_akimenko@ukr.net
Public contact
Name of contact person
| 1st name | Sergiy |
| Middle name | |
| Last name | Voznesenskyy |
Organization
O. M. Marzieiev Institute of Public Health of the National Academy of Medical Sciences of Ukraine
Division name
Affiliated external researcher
Zip code
02660
Address
50 Popudrenko Street, Kyiv, Ukraine
TEL
+380-50-625-0771
Homepage URL
svoznesenskyy@css.edu
Sponsor or person
Institute
O. M. Marzieiev Institute of Public Health of the National Academy of Medical Sciences of Ukraine
Institute
Department
Personal name
Funding Source
Organization
Researchers who are employees of O. M. Marzieiev Institute of Public Health will receive compensation (salary) from the institution
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
O. M. Marzieiev Institute of Public Health of the National Academy of Medical Sciences of Ukraine
Address
50 Popudrenko Street, Kyiv, 02660, Ukraine
Tel
+380-44-292-06-29
5131528@ukr.net
Secondary IDs
Secondary IDs
YES
Study ID_1
Universal Trial Number (UTN): U1111-1245-8858
Org. issuing International ID_1
World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
https://www.cochranelibrary.com/central/doi/10.1002/central/CN-02070691/full
Publication of results
Unpublished
Result
URL related to results and publications
https://www.cochranelibrary.com/central/doi/10.1002/central/CN-02070691/full
Number of participants that the trial has enrolled
60
Results
Will be shared after data analysis is completed
Results date posted
| 2022 | Year | 06 | Month | 23 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Data analysis delay
Date of the first journal publication of results
Baseline Characteristics
Will be shared after data analysis is completed
Participant flow
Will be shared after data analysis is completed
Adverse events
None
Outcome measures
Will be shared after data analysis is completed
Plan to share IPD
Individual participant data will be available on request
IPD sharing Plan description
IPD will be available on a reasonable request from the authors
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 14 | Day |
Last modified on
| 2022 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044337
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