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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038884
Receipt No. 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 2020/06/13

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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
Email 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
Email svoznesenskyy@css.edu

Sponsor
Institute O. M. Marzieiev Institute of Public Health of the National Academy of Medical Sciences of Ukraine
Institute
Department

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
Email 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
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
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
2020 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044337

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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