UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022100 |
|---|---|
| Receipt number | R000025479 |
| Scientific Title | Trial test for hair wash pad: Design and manufacturing technology of disposable absorbent pad for hair wash |
| Date of disclosure of the study information | 2016/04/27 |
| Last modified on | 2017/12/22 10:02:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Trial test for hair wash pad: Design and manufacturing technology of disposable absorbent pad for hair wash
Acronym
Trial test for hair wash pad
Scientific Title
Trial test for hair wash pad: Design and manufacturing technology of disposable absorbent pad for hair wash
Scientific Title:Acronym
Trial test for hair wash pad
Region
| Japan |
Condition
Condition
Nurse
Patient
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For patient hair wash in hospital setting, macromolecule absorption polymer including paper nappy, is frequently used. However, ethical issue is definite to use nappy for hair wash. Addition to this ethical issue, an excited hair wash sheet has limitations. Therefore, development for hair wash pad is important.
Prototype was developed between May 2015 and February 2016. With simulated patients, easiness of using, water absorption condition, water leakage, how it looks were tested. At the end of the prototype development phase, we had two types of prototypes. Our trial test aims to evaluate these prototypes in the real clinical settings.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Nurse: time spent with pad, water volume, water absorbed condition, easiness of using, and design et al.
Patient: comfortableness, and efficiency
Key secondary outcomes
Nurse: comparison with former method
Patient: comparison with former method
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
Nurse: being a nurse, no matter of nursing experience year, and no matter of sex
Patient: need hair wash in bed, adult, and no matter of sex
Key exclusion criteria
Nurse: N/A
Patient: Critical condition, and not be able to consent even with legal representative
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sachiko Makabe |
Organization
Akita university graduate school of health sciences
Division name
Department of clinical nursing
Zip code
Address
1-1-1, Hondo, Akita city, Akita prefecture, 010-8543, Japan
TEL
+81-18-884-6539
1smakabe@gipc.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachiko Makabe |
Organization
Akita university graduate school of health sciences
Division name
Department of clinical nursing
Zip code
Address
1-1-1, Hondo, Akita city, Akita prefecture, 010-8543, Japan
TEL
+81-18-884-6539
Homepage URL
1smakabe@gipc.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Kao corporation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
秋田大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 27 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 07 | Month | 31 | Day |
Other
Other related information
Nurse: time spent with pad, water volume, water absorbed condition, easiness of using, and design et al.
Patient: comfortableness, and efficiency
Management information
Registered date
| 2016 | Year | 04 | Month | 27 | Day |
Last modified on
| 2017 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025479
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
