UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050737 |
|---|---|
| Receipt number | R000053734 |
| Scientific Title | Effects of wearing surgical and N95 masks in the operating room situations on speech intelligibility against phrases which are easily mistaken |
| Date of disclosure of the study information | 2023/06/07 |
| Last modified on | 2023/10/01 08:13:38 |
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Basic information
Public title
Effects of wearing surgical and N95 masks in the operating room situations on speech intelligibility against phrases which are easily mistaken
Acronym
Effects of surgical and N95 masks on speech intelligibility
Scientific Title
Effects of wearing surgical and N95 masks in the operating room situations on speech intelligibility against phrases which are easily mistaken
Scientific Title:Acronym
Effects of surgical and N95 masks on speech intelligibility
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate how speech performance reduction by surgical masks or N95 affects intelligibility about Japanese phrases which are easily mistaken.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Speech intelligibility
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
None
Key exclusion criteria
dysacusis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | SATOKI |
| Middle name | |
| Last name | INOUE |
Organization
Fukushima Medical university
Division name
Anesthesiology
Zip code
9601295
Address
1 Hikarigaoka, Fukushima, Fukushima 9601295 Japan
TEL
024-547-1111
seninoue@fmu.ac.jp
Public contact
Name of contact person
| 1st name | SATOKI |
| Middle name | |
| Last name | INOUE |
Organization
Fukushima Medical university
Division name
Anesthesiology
Zip code
9601295
Address
1 Hikarigaoka, Fukushima, Fukushima 9601295 Japan
TEL
024-547-1111
Homepage URL
seninoue@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical university
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical university
Address
1 Hikarigaoka, Fukushima, Fukushima 9601295 Japan
Tel
024-548-1342
seninoue@fmu.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
| 2023 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
28
Results
Twenty-eight volunteers were recruited. Regarding speech intelligibility against explicit sentences between a surgical mask and an N95, speech intelligibility with an N95 was significantly lower with a surgical mask only during noise exposure with 60 dB.
Results date posted
| 2023 | Year | 03 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Caregivers in the operating room
Participant flow
28 persons were recruited, and no one dropped out.
Adverse events
None
Outcome measures
speech intelligibility
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2023 | Year | 03 | Month | 31 | Day |
Last modified on
| 2023 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053734
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
