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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043412
Receipt No. 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 2021/02/22

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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
Email 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
Email nobuto_nakanishi@yahoo.co.jp

Sponsor
Institute Tokushima University
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 86
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
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 02 Month 22 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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