UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055506 |
|---|---|
| Receipt number | R000063427 |
| Scientific Title | Survey on usability of straws (HiccAway) used in the United States among hospitalized patients in Japan: a prospective observational study |
| Date of disclosure of the study information | 2024/09/15 |
| Last modified on | 2024/09/15 12:03:59 |
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Basic information
Public title
Survey on usability of straws (HiccAway) used in the United States among hospitalized patients in Japan: a prospective observational study
Acronym
Survey on usability of straws (HiccAway) used in the United States among hospitalized patients in Japan: a prospective observational study
Scientific Title
Survey on usability of straws (HiccAway) used in the United States among hospitalized patients in Japan: a prospective observational study
Scientific Title:Acronym
Survey on usability of straws (HiccAway) used in the United States among hospitalized patients in Japan: a prospective observational study
Region
| Japan |
Condition
Condition
Not specified
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to have hospitalized patients use a straw (HiccAway) developed and sold in the United States and to evaluate its usability. The primary endpoint was to ask patients about their usability of the straw (HiccAway) using a 5-point scale: "1. Very easy to use," "2. Easy to use," "3. Neither," "4. Difficult to use," and "5. Very difficult to use."
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was to ask patients about their usability of the straw (HiccAway) using a 5-point scale: "1. Very easy to use," "2. Easy to use," "3. Neither," "4. Difficult to use," and "5. Very difficult to use."
Key secondary outcomes
As a secondary endpoint, patients' preference regarding repeated use of the straw (HiccAway) was asked using a 3-point scale of "1. I would like to use it," "2. Neither," or "3. I don't think I will use it." In addition, patients were asked whether they had choked when using the straw (HiccAway), whether there were any inconveniences, and their impressions of using it. Furthermore, if the patient experienced hiccups for any reason during hospitalization, the following information was also collected. The cause of the hiccups was not asked.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients must be hospitalized at Mie University Hospital
18 years of age or older
Able to communicate in Japanese
Able to answer questionnaires asking about usage and other conditions
Persons who have been given permission by a doctor to drink water
Persons who have given written consent to participate in the study
Key exclusion criteria
If the doctor or nurse in charge judges it inappropriate for the participant to participate in this study
If the principal investigator or co-investigator judges it inappropriate for the participant to be included in the study
If the participant has been instructed not to eat or drink
If there is a high possibility of aspiration
If the participant has used the same straw (HiccAway) in the past
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Kishi |
Organization
MIEUNIVERSITY
Division name
Graduate School of Medicine
Zip code
514-8507
Address
1577 Kurimamachiyacho, Tsu City, Mie Prefecture.
TEL
08034330840
324M103@m.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Kishi |
Organization
MIEUNIVERSITY
Division name
Graduate School of Medicine
Zip code
514-8507
Address
1577 Kurimamachiyacho, Tsu City, Mie Prefecture
TEL
08034330840
Homepage URL
324M103@m.mie-u.ac.jp
Sponsor or person
Institute
MIEUNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
MIEUNIVERSITY
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
MIEUNIVERSITY
Address
1577 Kurimamachiyacho, Tsu City, Mie Prefecture
Tel
08034330840
324M103@m.mie-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
| 2024 | Year | 09 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2024 | Year | 09 | Month | 15 | Day |
Last modified on
| 2024 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063427
