UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043412 |
|---|---|
| Receipt number | R000049567 |
| Scientific Title | The disparity between subjective thirst perception and objective dry mouth assessments in the intensive care patients |
| Date of disclosure of the study information | 2021/02/22 |
| Last modified on | 2021/07/20 09:25:33 |
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Basic information
Public title
The disparity between subjective thirst perception and objective dry mouth assessments in the intensive care patients
Acronym
The disparity between subjective thirst perception and objective dry mouth assessments in the intensive care patients
Scientific Title
The disparity between subjective thirst perception and objective dry mouth assessments in the intensive care patients
Scientific Title:Acronym
The disparity between subjective thirst perception and objective dry mouth assessments in the intensive care patients
Region
| Japan |
Condition
Condition
Patients in the intensive care unit
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the disparity between subjective thirst perception and objective dry mouth assessments for contributing to reducing subjective thirst perception.
Basic objectives2
Others
Basic objectives -Others
Observational analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between subjective thirst perception and objective dry mouth assessments.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients who were aged more than or equal to 20 years old
Key exclusion criteria
We excluded patients who can not communicate due to disorientation or delirium.
Target sample size
86
Research contact person
Name of lead principal investigator
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Tokushima University Hospital
Division name
Emergency and Critical Care Medicine
Zip code
770-8503
Address
2-50-1 Kuramoto, Tokushima 770-8503, Japan
TEL
088-631-7151
nobuto_nakanishi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Tokushima University Hospital
Division name
Emergency and Critical Care Medicine
Zip code
770-8503
Address
2-50-1 Kuramoto, Tokushima 770-8503, Japan
TEL
088-631-7151
Homepage URL
nobuto_nakanishi@yahoo.co.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Tokushima University
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
Clinical research ethics committees of nursing department in Tokushima University Hospital
Address
50-1, Kuramoto, Tokushima
Tel
088-633-9294
awachiken@tokushima-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
| 2021 | Year | 02 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0964339721000628?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0964339721000628?via%3Dihub
Number of participants that the trial has enrolled
86
Results
After oral care, thirst scores decreased by 1 (0 to 3, p < 0.01) and remained low only for one hour. Oral moisture was maintained at a normal level > 27.0%, and mROAG was at a low level < 4 before and after the oral care.
Results date posted
| 2021 | Year | 07 | Month | 20 | 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
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The thirst perception was assessed using a numerical rating scale (NRS). Dry mouth was assessed using oral moisture checking device (Scalar, Japan) and modified Revised Oral Assessment Guide (mROAG) including tongue, mucous membrane, and saliva assessments.
Management information
Registered date
| 2021 | Year | 02 | Month | 22 | Day |
Last modified on
| 2021 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049567
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
