UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003980 |
|---|---|
| Receipt number | 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 16:11:00 |
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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
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
sumisumi@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004797
