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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044111
Receipt No. R000050369
Scientific Title Development and effectiveness verification of the animation instruction for pelvic floor muscle exercises, featuring visualization.
Date of disclosure of the study information 2021/05/05
Last modified on 2021/05/05

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Basic information
Public title Development and effectiveness verification of the animation instruction for pelvic floor muscle exercises, featuring visualization.
Acronym Development and effectiveness verification of the animation instruction for pelvic floor muscle exercises, featuring visualization.
Scientific Title Development and effectiveness verification of the animation instruction for pelvic floor muscle exercises, featuring visualization.
Scientific Title:Acronym Development and effectiveness verification of the animation instruction for pelvic floor muscle exercises, featuring visualization.
Region
Japan

Condition
Condition Postpartum women
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effects of the developed animation instruction for pelvic floor muscle exercises are verified in women one month after giving birth.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The following items before and after the intervention (at 3 months)
Pelvic floor muscle strength
Presence or absence of pelvic floor muscle contraction
General Self-efficacy Scale (GSES)
Urinary incontinence: ICIQ-SF (Japanese version)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Three-month intervention for pelvic floor muscle exercises according to the leaflet instruction.
Interventions/Control_2 Three-month intervention for pelvic floor muscle exercises according to the developed animation instruction.
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
45 years-old >=
Gender Female
Key inclusion criteria Women who gave a single birth at term and participated in a medical examination or childcare group one month after giving birth are included.
Key exclusion criteria Women who may have problems, such as pain due to pelvic floor muscle contraction, or have diseases or factors that are likely to affect pelvic floor muscle strength are included.
Target sample size 52

Research contact person
Name of lead principal investigator
1st name Kiyoko
Middle name
Last name Naito
Organization Biwako Gakuin University
Division name Faculty of Education and Welfare Science
Zip code 527-8533
Address 29 Fuse-cho Higashi Ohmi-City Shiga Prefecture
TEL 0748-22-3388
Email masaki03@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name Kiyoko
Middle name
Last name Naito
Organization Biwako Gakuin University
Division name Faculty of Education and Welfare Science
Zip code 527-8533
Address 29 Fuse-cho Higashi Ohmi-City Shiga Prefecture
TEL 0748-22-3388
Homepage URL
Email k-naito@biwakogakuin.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization JAPAN SOCIETY FOR THE PROMOTION OF SCIENCE
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 University of Tsukuba Medical Ethics Committee
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577 Japan
Tel 029-853-3914
Email t-credo.adm@un.tsukuba.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 野村産婦人科(滋賀県)   
Nomura Obstetrics and Gynecology

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 05 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 201
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 No longer recruiting
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 05 Month 13 Day
Anticipated trial start date
2019 Year 05 Month 13 Day
Last follow-up date
2021 Year 01 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 05 Month 05 Day
Last modified on
2021 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050369

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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