UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054962 |
|---|---|
| Receipt number | R000062800 |
| Scientific Title | The Potential of Quantitative Pain Assessment Using EEG and ECG Measurements in Patients with Acute Postoperative Pain. |
| Date of disclosure of the study information | 2024/07/14 |
| Last modified on | 2025/07/15 10:09:39 |
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Basic information
Public title
The Potential of Quantitative Pain Assessment Using EEG and ECG Measurements in Patients with Acute Postoperative Pain.
Acronym
The Potential of Quantitative Pain Assessment Using EEG and ECG Measurements in Patients with Acute Postoperative Pain.
Scientific Title
The Potential of Quantitative Pain Assessment Using EEG and ECG Measurements in Patients with Acute Postoperative Pain.
Scientific Title:Acronym
The Potential of Quantitative Pain Assessment Using EEG and ECG Measurements in Patients with Acute Postoperative Pain.
Region
| Japan |
Condition
Condition
Patients with Acute Postoperative Pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of early postoperative electrocardiography (ECG) and electroencephalography (EEG) measurements as predictive tools for prognosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pain from the day after surgery to one month postoperatively
electroencephalography (EEG)
electrocardiography (ECG)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Using electroencephalography (EEG) and electrocardiography (ECG) as physiological assessments to detect pain-related EEG and ECG activity.
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
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with clinical pain in acute phase
Key exclusion criteria
dementia
gait disturbance
Patients with aphasia who cannot understand the research or the explanation of the assignment.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Morikawa |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2, Umaminaka, Hiroyo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
yuki.morikawa.89@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Morikawa |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2, Umaminaka, Hiroyo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
Homepage URL
yuki.morikawa.89@gmail.com
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
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
kio university
Address
4-2-2, Umaminaka, Hiroyo-cho, Kitakatsuragi-gun, Nara
Tel
0745541601
yuki.morikawa.89@gmail.com
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
| 2024 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062800
