UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035621 |
|---|---|
| Receipt number | R000040429 |
| Scientific Title | Lance evoked potential of healthy adults: a pretest |
| Date of disclosure of the study information | 2019/01/22 |
| Last modified on | 2021/08/06 18:01:39 |
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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)
Event-related potential (ERP)
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
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
082-257-1761
Homepage URL
d176710@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
9
Results
There was no significant difference between the latency of negative waveform (N2) and subsequent positive waveform (P2) potentials following the lancet stimulation and control stimulation.
Results date posted
| 2021 | Year | 08 | Month | 06 | Day |
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
Completed
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
| 2021 | Year | 07 | 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 | 01 | Month | 22 | Day |
Last modified on
| 2021 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
