UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054743 |
|---|---|
| Receipt number | R000062450 |
| Scientific Title | Effects of masks on pain reduction in post-tonsillectomy patients |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/11/13 15:37:30 |
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Basic information
Public title
Effects of masks on postoperative pain reduction in tonsillectomy patients
Acronym
A study of the effectiveness of masks after tonsillectomy
Scientific Title
Effects of masks on pain reduction in post-tonsillectomy patients
Scientific Title:Acronym
A study of the effectiveness of masks after tonsillectomy
Region
| Japan |
Condition
Condition
Tonsillectomy, tonsillar hypertrophy, habitual tonsillitis, tonsillar focal diseases
Classification by specialty
| Oto-rhino-laryngology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine whether wearing a mask decreases post-tonsillectomy pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
post oparative pain (Numeri Rating Scale:0-10)
Pain upon waking and eating will be evaluated daily for one week after surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Wear a mask after tonsilectomy
Interventions/Control_2
Not wear a mask after tonsillectomy
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
| 17 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo bilateral tonsillectomy for tonsillar hypertrophy, habitual tonsillitis, or tonsillar focal diseases at Kurashiki Central Hospital
Key exclusion criteria
Patients who have malignant parapharyngeal tumor
Patients who have hemilateral tonsillectomy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Kimata |
Organization
Kurashiki Central Hospital Otorhinolaryngology, Head and Neck Surgery
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
710-0052
Address
1-1-1 Miwa, Kurashiki City, Okayama Prefecture, Japan
TEL
(+81)86-422-0210
yukikimata153@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kimata |
Organization
Kurashiki Central Hospital
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
710-0052
Address
1-1-1 Miwa, Kurashiki City, Okayama Prefecture, Japan
TEL
(+81)86-422-0210
Homepage URL
yukikimata153@gmail.com
Sponsor or person
Institute
Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
No Funding Source
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
Kurashiki Central Hospital
Address
Miwa 1-1-1, Kurashiki, Okayama
Tel
(+81)86-422-0210
yukikimata153@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 | 01 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 24 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062450
