UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056272 |
|---|---|
| Receipt number | R000062754 |
| Scientific Title | Effects of wearing surgical mask, N95 mask, and double mask when speaking on physiological aspects and subjective evaluation |
| Date of disclosure of the study information | 2024/11/26 |
| Last modified on | 2024/11/26 10:47:52 |
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Basic information
Public title
Effects of wearing surgical mask, N95 mask, and double mask when speaking on physiological aspects and subjective evaluation
Acronym
Effects of wearing masks when speaking
Scientific Title
Effects of wearing surgical mask, N95 mask, and double mask when speaking on physiological aspects and subjective evaluation
Scientific Title:Acronym
Effects of wearing masks when speaking when speaking on physiological aspects and subjective evaluation
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify effects of wearing surgical mask, N95 mask, and double mask when speaking on physiological aspects and subjective evaluation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Physiological Evaluations(Pulse rate,Saturation of percutaneous oxygen,Respiratory rate,Blood pressure)and Subjective Evaluations(Stuffiness,Fatigue,Stiffness during vocalization,Throat dryness,Heat in the mask)
Key secondary outcomes
Subject's background,Environment inside the mask(Temperature& Humidity),Number of words read aloud
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Wearing a surgical mask when speaking
Interventions/Control_2
Wearing a N95 mask when speaking
Interventions/Control_3
Wearing double masks(surgicalmask & N95) when speaking
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
| 19 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Have no history of respiratory disease and no health problems.
Have sufficient eyesight to read a manuscript placed at a distance of 60cm from the eyes.(No matter whether vision correction devices are used.)
Have no difficulty in speaking continuously for about 10 minutes.
Have never suffered from skin lesions caused by medical tape or masks.
Key exclusion criteria
Those who do not meet the selection criteria
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Healthcare University
Division name
Division of Nursing, Higashigaoka Faculty of Nursing
Zip code
152-8558
Address
152-8558
TEL
03-5779-5031
to-takahashi@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Healthcare University
Division name
Division of Nursing, Higashigaoka Faculty of Nursing
Zip code
152-8558
Address
2-5-1 Higashigaoka, Meguro, Tokyo
TEL
03-5779-5031
Homepage URL
to-takahashi@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Funding Source
Organization
other
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
The Ethical Review Board for Human-related Research, Tokyo Healthcare University
Address
4-1-17 Higashigotanda, Shinagawa, Tokyo
Tel
03-5721-7655
rinri@thcu.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 | 11 | Month | 26 | 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
29
Results
No significant physiological differences were found between masks during reading.
The double layer mask was rated most uncomfortable, followed by N95 and surgical masks (p<.01).
The double layer mask increased temperature (p<.01), while double layer and N95 masks increased humidity (p<.01).
Participants read less text with the double layer mask (p<.05), suggesting potential negative impacts on information delivery.
Results date posted
| 2024 | Year | 11 | Month | 26 | 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
| 2024 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 09 | 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 | 11 | Month | 26 | Day |
Last modified on
| 2024 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062754
