UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040029 |
|---|---|
| Receipt number | R000045570 |
| Scientific Title | Effects of Menthol on thirst in ICU patients: An exploratory randomized clinical trial |
| Date of disclosure of the study information | 2020/04/02 |
| Last modified on | 2024/06/02 18:00:48 |
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Basic information
Public title
Effects of Menthol on thirst in ICU patients: An exploratory randomized clinical trial
Acronym
Effects of Menthol on thirst in ICU patients: An exploratory randomized clinical trial
Scientific Title
Effects of Menthol on thirst in ICU patients: An exploratory randomized clinical trial
Scientific Title:Acronym
ICU-thirst
Region
| Japan |
Condition
Condition
ICU patients
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to exploratively evaluate the efficacy of menthol in ICU patients undergoing abstinence from eating and drinking by comparing whether menthol in mouthwash or swab cleansing reduces dry mouth with tap water.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective Thirst Analog Scale Immediately After Oral Care Implementation
Key secondary outcomes
The number of hours of oral care the patient wanted after implementation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
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
| Other |
Interventions/Control_1
Non-intubated patients should gargle with menthol water three times in sequence. Intubate patients are wiped three times consecutively with a swab of menthol water.
Interventions/Control_2
Non-intubated patients should gargle with water three times in sequence. Intubate patients are wiped three times consecutively with a swab of water.
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
1)Adult patients who have given written consent to participate in the study
2)Patients scheduled to be admitted to the ICU or admitted as an emergency
3)The period of prohibited eating and drinking is longer than 24 hours.
4)GCS:E3V5(T)M6, sedation depth at RASS 0. Patients who can communicate.
5)Patients who do not have ulcers in their mouths or who do not have the potential for pain.
6)Patients who do not have a problem with menthol
Key exclusion criteria
1)Blood sodium concentration is 150 mEq/L or more
2)Patients who have difficulty communicating in Japanese and reading and writing in Japanese
3)Patients whose inclusion in the study is deemed inappropriate by the investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Sakamoto |
Organization
Center Hospital of the National Center for Global Health and Medicine
Division name
ICU
Zip code
162-8655
Address
1-21-1 Toyama Shinjuku-ku, Tokyo
TEL
03-3202-7181
asakamoto@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Umeda |
Organization
Center Hospital of the National Center for Global Health and Medicine
Division name
Nursing department
Zip code
162-8655
Address
1-21-1 Toyama Shinjuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
aumeda@hosp.ncgm.go.jp
Sponsor or person
Institute
ICU, Center Hospital of the National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
nothing
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
National Center for Global Health and Medicine Ethics Board
Address
1-21-1 Toyama Shinjuku-ku, Tokyo
Tel
03-3202-7181
rinrijm@hosp.ncgm.go.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
国立国際量研究センター病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 02 | Day |
Related information
URL releasing protocol
https://confit.atlas.jp/guide/event/jaccn18/subject/O1-01/date?cryptoId=
Publication of results
Partially published
Result
URL related to results and publications
https://confit.atlas.jp/guide/event/jaccn18/subject/O1-01/date?cryptoId=
Number of participants that the trial has enrolled
80
Results
Change in scale before and after oral care was 3.2 in the intervention group (INT-G) and 3.3 in the control group(CONT-G) for thirst intensity NRS, and 3.0 in the INT-G and 3.2 in the CONT-G for thirst pain severity NRS, with no statistically significant difference between the two groups for the two items. The mean thirst intensity NRS immediately before oral care was 7.0 in the INT-G and 7.2 in the CONT-G, and the mean thirst pain NRS was 7.0 in the INT-G and 6.9 in the CONT-G.
Results date posted
| 2024 | Year | 06 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age was 60.7 years in the intervention group and 61.97 years in the control group. Males were 45% in the intervention group and 44.7% in the control group.
Participant flow
After the investigator explained the study to the eligible patients and obtained their consent, the background information such as the subjects' date of birth, gender, etc., and the subject identification code were filled in on the eligibility form to confirm that there were no problems with the selection and exclusion criteria. A computer application was used to determine the allocation group.
Adverse events
none
Outcome measures
Amount of change in scale before and after oral care
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 02 | Day |
Last modified on
| 2024 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045570
