UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of warm sitz bath for early postpartum primiparous women
Title of the study (Brief title)	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	Shoko Takeuchi
Organization	Yokohama City University
Division name	School of Medicine, Nursing Course
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	Shoko Takeuchi
Organization	Yokohama City University
Division name	School of Medicine, Nursing Course
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 06 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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