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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044514
Receipt No. R000050856
Scientific Title A randomized, controlled, interventional study
Date of disclosure of the study information 2021/06/11
Last modified on 2021/06/11

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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
Email 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
Email ytateoka@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050856

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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