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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003980
Receipt No. R000004797
Scientific Title Development and effectiveness of nursing tools for pain relief and promotion of perineal healing during the early postpartum period
Date of disclosure of the study information 2010/08/02
Last modified on 2010/08/02

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Basic information
Public title Development and effectiveness of nursing tools for pain relief and promotion of perineal healing during the early postpartum period
Acronym Development and effectiveness of nursing tools for pain relief and promotion of perineal healing during the early postpartum period
Scientific Title Development and effectiveness of nursing tools for pain relief and promotion of perineal healing during the early postpartum period
Scientific Title:Acronym Development and effectiveness of nursing tools for pain relief and promotion of perineal healing during the early postpartum period
Region
Japan

Condition
Condition Women with a normal early postpartum course
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Application of a hot fomentation to the episiotomy wound and evaluation of the healing process and the effectiveness of pain relief
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Application of a hot fomentation every urination and evaluation of the episiotomy wound on the first and fourth day postpartum using the REEDA score
Key secondary outcomes Evaluation of changes in episiotomy pain from the first to the fourth day postpartum using a VAS scale

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 In the intervention group, a hot fomentation is applied every urination from the first to the fourth day postpartum

Self-administered questionnaire
Interventions/Control_2 In the control group, no application of hot fomentation is performed

Self-administered questionnaire
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Women one to four days postpartum
Normal pregnancy
Normal childbirth
1to2degree perineal laceration
Key exclusion criteria Serious preexisting condition
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sumie Yamada
Organization University of Fukui
Division name School of Nursing, Faculty of Medical Sciences
Zip code
Address 23-3 Shimoaizuki, Matsuoka, Eiheiji-cho, Yosida-gun, Fukui, 910-1193
TEL 0776-61-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sumie Yamada
Organization University of fukui
Division name School of Nursing, Faculty of Medical Sciences
Zip code
Address 23-3 Shimoaizuki, Matsuoka, Eiheiji-cho, Yosida-gun, Fukui, 910-1193
TEL 0776-61-3111
Homepage URL
Email sumisumi@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

Funding Source
Organization Fukui Medical Instruments Inc
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Fukui Red Cross Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 福井赤十字病院(福井県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 02 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 Enrolling by invitation
Date of protocol fixation
2010 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2011 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 02 Day
Last modified on
2010 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004797

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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