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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035621
Receipt No. R000040429
Scientific Title Lance evoked potential of healthy adults: a pretest
Date of disclosure of the study information 2019/01/22
Last modified on 2019/07/24

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Basic information
Public title Lance evoked potential of healthy adults: a pretest
Acronym Lance evoked potential of healthy adults: a pretest
Scientific Title Lance evoked potential of healthy adults: a pretest
Scientific Title:Acronym Lance evoked potential of healthy adults: a pretest
Region
Japan

Condition
Condition healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This is a preliminary study to investigate the effect of music on heel lance in infants by EEG measurement. Study 1 reveals that lance in healthy adults is a pain by evoked potential; Study 2 investigates the pain relief effect of music on healthy adults' lance.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Electroencephalogram (EEG)
Key secondary outcomes Electromyogram (EMG)
Electrocardiogram (ECG)
Visual Analogue Scale (VAS)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Forefoot lance stimulation 1sec/10times
Leg lance stimulation 1sec/10times
Interventions/Control_2
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) The healthy student belonging to Hiroshima University who is 20 years and older at the test time
(2) The person who provides written consent for the participation in this research
Key exclusion criteria (1) Analgesic drug usage within 48 hours prior to the test
(2) The person with research interests and research subjects has a relationship between teacher and student, and a student has interests such as taking lectures of research staff.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Ikuko
Middle name
Last name Sobue
Organization Hiroshima University
Division name Graduate School of Biomedical & Health Sciences
Zip code 734-8553
Address Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL 082-257-5370
Email sobue@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Yui
Middle name
Last name Shiroshita
Organization Hiroshima University
Division name Graduate School of Biomedical & Health Sciences
Zip code 734-8553
Address Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL 082-257-5371
Homepage URL
Email d176710@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
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 Hiroshima University
Address Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
Tel 082-257-1551
Email iryo-seisaku@office.hiroshima-u.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
2019 Year 01 Month 22 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 Open public recruiting
Date of protocol fixation
2019 Year 01 Month 21 Day
Date of IRB
2019 Year 04 Month 16 Day
Anticipated trial start date
2019 Year 04 Month 16 Day
Last follow-up date
2020 Year 01 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
2019 Year 01 Month 22 Day
Last modified on
2019 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040429

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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