UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040122 |
|---|---|
| Receipt number | R000045748 |
| Scientific Title | Prevalence of central sensitivity syndrome in workers engaged in medical and nursing care and effectiveness of interventions that take into account central sensitivity syndrome |
| Date of disclosure of the study information | 2020/04/10 |
| Last modified on | 2024/11/06 20:14:42 |
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Basic information
Public title
Prevalence of central sensitivity syndrome in workers engaged in medical and nursing care and effectiveness of interventions that take into account central sensitivity syndrome
Acronym
Prevalence of central sensitivity syndrome in workers engaged in medical and nursing care and effectiveness of interventions that take into account central sensitivity syndrome
Scientific Title
Prevalence of central sensitivity syndrome in workers engaged in medical and nursing care and effectiveness of interventions that take into account central sensitivity syndrome
Scientific Title:Acronym
Prevalence of central sensitivity syndrome in workers engaged in medical and nursing care and effectiveness of interventions that take into account central sensitivity syndrome
Region
| Japan |
Condition
Condition
healthy adults (worker)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. to examine the prevalence of central sensitivity syndrome in the workers engaged in medical and nursing care , and 2. to examine the effectiveness of physical therapy targeting central sensitization in workers with a high severity of central sensitivity syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
total score of Central Sensitization Inventory
Key secondary outcomes
score of absolute and relative presenteeism, subscales of the World Health Organization Health and Work Performance Questionnaire Shortened Version (WHO-HPQ, Japanese version)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
education about central sensitivity syndrome and self-care methods
Interventions/Control_2
no treatment
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
medical and care workers who work for social welfare corporations (doctors, nurses, physiotherapists, occupational therapists, care workers, care managers, etc.)
Key exclusion criteria
(1) Those with serious cognitive problems
(2) Those who have a central disease such as a stroke
(3) During pregnancy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Mibu |
Organization
Konan Women's University
Division name
Faculty of nursing and rehabilitation, Department of physical therapy
Zip code
658-0001
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyogo
TEL
078-413-3691
a_mibu@konan-wu.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Mibu |
Organization
Konan Women's University
Division name
Faculty of nursing and rehabilitation, Department of physical therapy
Zip code
658-0001
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyogo
TEL
078-413-3691
Homepage URL
a_mibu@konan-wu.ac.jp
Sponsor or person
Institute
Konan Women's University
Institute
Department
Personal name
Funding Source
Organization
Prefectual University of Hiroshima
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
Konan Women's University
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyogo
Tel
078-413-3691
a_mibu@konan-wu.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
| 2020 | Year | 04 | Month | 10 | 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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045748
