UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054728 |
|---|---|
| Receipt number | R000062543 |
| Scientific Title | Effects of single-session training with next-generation belt electrode skeletal muscle electrical stimulation on postpartum women's mental health: a randomized controlled trial |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2025/06/22 22:21:00 |
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Basic information
Public title
Effects of single-session training with next-generation belt electrode skeletal muscle electrical stimulation on postpartum women's mental health: a randomized controlled trial
Acronym
Effects of single-session training with next-generation belt electrode skeletal muscle electrical stimulation on postpartum women's mental health: a randomized controlled trial
Scientific Title
Effects of single-session training with next-generation belt electrode skeletal muscle electrical stimulation on postpartum women's mental health: a randomized controlled trial
Scientific Title:Acronym
Effects of single-session training with next-generation belt electrode skeletal muscle electrical stimulation on postpartum women's mental health: a randomized controlled trial
Region
| Japan |
Condition
Condition
Postpartum women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of a single training session with the next-generation belt electrode skeletal muscle electrical stimulation on the mental health of postpartum women.
To explore the effects of a single training session with next-generation belt electrode skeletal muscle electrical stimulation on blood biomarkers and autonomic function indices in postpartum women.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in total mood disturbance (TMD) scores on the Japanese short version of the Profile of Mood States 2nd Edition (POMS2) before and after intervention
Key secondary outcomes
Differences in the Visual Analogue Scale (VAS) for psychological state before and after the intervention
Differences in blood biomarkers before and after intervention
Differences in autonomic function indices before and after intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Other |
Interventions/Control_1
Single-session training with belt electrode next-generation skeletal muscle electrical stimulation
Interventions/Control_2
Rest
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women who had a 1-month postpartum checkup
Key exclusion criteria
Those with an abnormal obstetric course
Other conditions in which the physician determines that participation in the study is undesirable.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Egawa |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gynecology and Obstetrics
Zip code
606-8507
Address
54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
075-751-3269
megawa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Ohsuga |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gynecology and Obstetrics
Zip code
606-8507
Address
54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
075-751-3269
Homepage URL
ohsuga@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
Miho Egawa
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 01 | 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
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 06 | Month | 21 | Day |
Last modified on
| 2025 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062543
