UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054105 |
|---|---|
| Receipt number | R000061775 |
| Scientific Title | Effects of Wearing Personal Protective Equipment(PPE) for Infectious Diseases on Physiological and Psychological Reactions and Cognitive Task Performance: Differences in the Type of PPE |
| Date of disclosure of the study information | 2024/04/20 |
| Last modified on | 2024/04/10 14:37:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Physiological and Psychological Reactions to Wearing Personal Protective Equipment for Infectious Diseases
Acronym
Physiological and psychological burden of wearing personal protective equipment for infectious diseases
Scientific Title
Effects of Wearing Personal Protective Equipment(PPE) for Infectious Diseases on Physiological and Psychological Reactions and Cognitive Task Performance: Differences in the Type of PPE
Scientific Title:Acronym
Effects of different types of PPE on physiological and psychological responses and cognitive task performance
Region
| Japan |
Condition
Condition
Not applicate
Classification by specialty
| Nursing | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of nursing care simulation wearing Personal Protective Equipment (PPE) on thermoregulatory responses, thermal discomfort, and cognitive task performance, with a focus on different types of PPE.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin temperature, subjective responses (warm/cold, thermal discomfort, sweating), percentage of correct responses to cognitive function tasks, and response time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
PPE1 (gown, mask, gloves)
Interventions/Control_2
PPE2 (apron, mask, gloves)
Interventions/Control_3
CON (gloves only)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. have no underlying medical problems
2. have a full understanding of the research plan and are able to give their consent
3. be at least 18 years of age at the time of consent
4. undergraduate and graduate students who are capable of performing nursing care simulations under supervision.
Key exclusion criteria
1. a person who is pregnant or may possibly become pregnant;
2. who is determined by the investigator to be inappropriate as a research subject.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Nobuko |
| Middle name | |
| Last name | Hashiguchi |
Organization
Kyushu University
Division name
Graduate School of Medical Science
Zip code
8128582
Address
3-1-1Maidashi Higashiku Fukuoka Japan
TEL
0926426714
hashiguchi.nobuko.053@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuko |
| Middle name | |
| Last name | Hashiguchi |
Organization
Kyushu University
Division name
Graduate School of Medical Science
Zip code
8150034
Address
3-1-1Maidashi Higashiku Fukuoka Japan
TEL
0926426714
Homepage URL
hashiguchi.nobuko.053@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
MEXTJapan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University
Address
3-1-1Maidashi Higashiku Fukuoka Japan
Tel
0926425082
byskenkyu@jimu.kyushu-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
| 2024 | Year | 04 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | 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
| 2024 | Year | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061775
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
