UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044514 |
|---|---|
| Receipt number | R000050856 |
| Scientific Title | A randomized, controlled, interventional study |
| Date of disclosure of the study information | 2021/06/11 |
| Last modified on | 2021/06/11 21:38:34 |
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Basic information
Public title
Effectiveness of an aloe fomentation for nipple-related complications during the early puerperium period: A randomized, controlled, interventional study
Acronym
Effectiveness of an aloe fomentation for nipple-related complications during the early puerperium period
Scientific Title
A randomized, controlled, interventional study
Scientific Title:Acronym
RCT
Region
| Japan |
Condition
Condition
nipple cracks
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study tested an aloe fomentation applied to the nipples as a method of caring for nipple-related complications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of nipple-related complications
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
the aloe fomentation
5 days
6 times a day
Apply aloe compress to the nipple
Interventions/Control_2
control
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Those without cracked nipples at the start of breastfeeding
Key exclusion criteria
Those with abnormalities in the course of delivery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | YUMIKO |
| Middle name | |
| Last name | TATEOKA |
Organization
Shiga University of Medical Science
Division name
Faculty of Nursing
Zip code
5202192
Address
SetaTsukinowa-cho,Otsu
TEL
0775482433
ytateoka@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | YUMIKO |
| Middle name | |
| Last name | TATEOKA |
Organization
Shiga University of Medical Science
Division name
Faculty of Nursing
Zip code
5202192
Address
SetaTsukinowa-cho,Otsu
TEL
0775482433
Homepage URL
ytateoka@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
Shiga University of Medical Science
Address
Seta Tsukinowa-cho, Otsu
Tel
0775482433
ytateoka@belle.shiga-med.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 | 06 | Month | 11 | 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
65
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
| 2008 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2007 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2008 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 11 | Day |
Last modified on
| 2021 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050856
