UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044111 |
|---|---|
| Receipt number | 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 | 2024/11/05 18:36:27 |
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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
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
k-naito@biwakogakuin.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
A total of 36 and 30 subjects were enrolled in groups A and L, respectively.Prior to the intervention, there were no differences in pelvic floor muscle strength, contraction of the pelvic floor muscle, or ICIQ-SF between the groups (p=0.264-0.988). Following the intervention, there were significant differences in pelvic floor muscle strength, contraction of the pelvic floor muscle, and ICIQ-SF between the groups (p<0.000).
Results date posted
| 2023 | Year | 12 | Month | 18 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Paper submission is delayed.
Date of the first journal publication of results
| 2023 | Year | 08 | Month | 31 | Day |
Baseline Characteristics
Postpartum women who are doing well.
Participant flow
Postpartum women who agreed to participate in the study were assigned to groups based on the month in which the childcare circle was held.
Adverse events
nothing
Outcome measures
We measured the pelvic floor muscle strength using a pelvic muscle trainer and the degree of pelvic floor muscle contraction using ultrasound. We also measured the degree of urinary incontinence using the persistence rate and the International Consultation of Incontinence Questionnaire Short Form.
Plan to share IPD
nothing
IPD sharing Plan description
nothing
Progress
Recruitment status
Completed
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
| 2021 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 05 | Day |
Last modified on
| 2024 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050369
