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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032800
Receipt No. R000037404
Scientific Title The efficacy of warm sitz bath for early postpartum primiparous women
Date of disclosure of the study information 2018/06/01
Last modified on 2018/05/31

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Basic information
Public title The efficacy of warm sitz bath for early postpartum primiparous women
Acronym The efficacy of warm sitz bath for primiparous women
Scientific Title The efficacy of warm sitz bath for early postpartum primiparous women
Scientific Title:Acronym The efficacy of warm sitz bath for primiparous women
Region
Japan

Condition
Condition perineal pain during early postpartum
Classification by specialty
Obsterics and gynecology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of warm sitz baths in early postpartum primiparous women who underwent episiotomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Perineal pain
Key secondary outcomes 1)Heart rate variability
2)salivary amylase
3)Japanese translation of short version of Profile of Mood States 2

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Participants carry out a warm sitz bath for 10 minutes once after the second day postpartum.
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Correspond to all the following in recruitment for participants
1)Women are primipara.
2)Women had undergone episiotomy.
3)Women had vaginal delivery after full term.
4)The progress of postpartum is well.
5)women are Japanese and could read and write Japanese.
Key exclusion criteria Correspond to each the following in recruitment for participants
1)Women had 3rd or 4th perineal laceration.
2)Women had undergone removal of hematoma or resuture of perineum.
3)Women had still birth, neonatal death or their babies were hospitalized in NICU.
4)Women have a mental illness or complications.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoko Takeuchi
Organization Yokohama City University
Division name School of Medicine, Nursing Course
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL 045-787-2548
Email shoko@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoko Takeuchi
Organization Yokohama City University
Division name School of Medicine, Nursing Course
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL 045-787-2548
Homepage URL
Email shoko@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization JSPS
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 01 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
2018 Year 06 Month 04 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 31 Day
Last modified on
2018 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037404

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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