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利用者名
UMIN ID

試験進捗状況 参加者募集終了‐試験継続中/No longer recruiting
UMIN試験ID UMIN000038884
受付番号 R000044337
科学的試験名
一般公開日(本登録希望日) 2019/12/14
最終更新日 2022/06/23

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Effect of human body grounding on psychological and emotional state
一般向け試験名略称/Acronym
Effect of grounding on psychological and emotional state
科学的試験名/Scientific Title
Effect of human body grounding on psychological and emotional state: an experimental double-blind pragmatic randomized controlled trial
科学的試験名略称/Scientific Title:Acronym
Effect of grounding on psychological and emotional state
試験実施地域/Region
欧州/Europe

対象疾患/Condition
対象疾患名/Condition
General public
疾患区分1/Classification by specialty
成人/Adult
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/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.
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 その他/Others
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Positive and Negative Affect Scale, before and after exposure
副次アウトカム評価項目/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

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design クロスオーバー試験/Cross-over
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding 二重盲検/Double blind -all involved are blinded
コントロール/Control プラセボ・シャム対照/Placebo
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 封筒法/Numbered container method

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 予防・検診・検査/Prevention
介入の種類/Type of intervention
その他/Other
介入1/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.
介入2/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.
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
18 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
100 歳/years-old 未満/>
性別/Gender 男女両方/Male and Female
選択基準/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
除外基準/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
目標参加者数/Target sample size 40

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Volodymyr
ミドルネーム
Akimenko
所属組織/Organization
O. M. Marzieiev Institute of Public Health of the National Academy of Medical Sciences of Ukraine
所属部署/Division name
Laboratory of Physical Environmental Factors
郵便番号/Zip code 02660
住所/Address
50 Popudrenko Street, Kyiv, Ukraine
電話/TEL +380-50-625-0771
Email/Email v_ya_akimenko@ukr.net

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Sergiy
ミドルネーム
Voznesenskyy
組織名/Organization
O. M. Marzieiev Institute of Public Health of the National Academy of Medical Sciences of Ukraine
部署名/Division name
Affiliated external researcher
郵便番号/Zip code 02660
住所/Address
50 Popudrenko Street, Kyiv, Ukraine
電話/TEL +380-50-625-0771
試験のホームページURL/Homepage URL
Email/Email svoznesenskyy@css.edu

実施責任組織/Sponsor
機関名/Institute その他 O. M. Marzieiev Institute of Public Health of the National Academy of Medical Sciences of Ukraine
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Researchers who are employees of O. M. Marzieiev Institute of Public Health will receive compensation (salary) from the institution
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 海外/Outside Japan
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
O. M. Marzieiev Institute of Public Health of the National Academy of Medical Sciences of Ukraine
住所/Address
50 Popudrenko Street, Kyiv, 02660, Ukraine
電話/Tel +380-44-292-06-29
Email/Email 5131528@ukr.net

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs はい/YES
試験ID1/Study ID_1 Universal Trial Number (UTN): U1111-1245-8858
ID発行機関1/Org. issuing International ID_1
World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP)
試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2019 12 14

関連情報/Related information
プロトコル掲載URL/URL releasing protocol https://www.cochranelibrary.com/central/doi/10.1002/central/CN-02070691/full
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications https://www.cochranelibrary.com/central/doi/10.1002/central/CN-02070691/full
組み入れ参加者数/Number of participants that the trial has enrolled 60
主な結果/Results
Will be shared after data analysis is completed
主な結果入力日/Results date posted
2022 06 23
結果掲載遅延/Results Delayed
遅れる予定/Delay expected
結果遅延理由/Results Delay Reason
Data analysis delay
最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics
Will be shared after data analysis is completed
参加者の流れ/Participant flow
Will be shared after data analysis is completed
有害事象/Adverse events
None
評価項目/Outcome measures
Will be shared after data analysis is completed
個別症例データ共有計画/Plan to share IPD
Individual participant data will be available on request
個別症例データ共有計画の詳細/IPD sharing Plan description
IPD will be available on a reasonable request from the authors

試験進捗状況/Progress
試験進捗状況/Recruitment status 参加者募集終了‐試験継続中/No longer recruiting
プロトコル確定日/Date of protocol fixation
2019 10 21
倫理委員会による承認日/Date of IRB
2019 10 21
登録・組入れ開始(予定)日/Anticipated trial start date
2019 12 14
フォロー終了(予定)日/Last follow-up date
2020 12 30
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2019 12 14
最終更新日/Last modified on
2022 06 23


閲覧ページへのリンク/Link to view the page
URL(日本語) https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000044337
URL(英語) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044337

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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