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 2023/12/18 14:44:23

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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 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

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

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

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

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

2023 Year 12 Month 18 Day



Link to view the page

Value
https://center6.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