UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056495 |
|---|---|
| Receipt number | R000061602 |
| Scientific Title | Effectiveness of an online-based yoga program to improve back and pelvic pain in pregnant women :A Pilot randomized controlled trial |
| Date of disclosure of the study information | 2024/12/18 |
| Last modified on | 2024/12/18 20:01:39 |
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Basic information
Public title
Effectiveness of an online-based yoga program to improve back and pelvic pain in pregnant women :A Pilot randomized controlled trial
Acronym
Effectiveness of an online-based yoga program to improve back and pelvic pain in pregnant women :A Pilot randomized controlled trial
Scientific Title
Effectiveness of an online-based yoga program to improve back and pelvic pain in pregnant women :A Pilot randomized controlled trial
Scientific Title:Acronym
Effectiveness of an online-based yoga program to improve back and pelvic pain in pregnant women :A Pilot randomized controlled trial
Region
| Japan |
Condition
Condition
Pregnant women
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to determine the effect size of the outcome measures of the degree of back and pelvic pain, degree of impairment of daily living, improvement in depressive symptoms, and yoga persistence status. In addition, the feasibility of the yoga proclam will be examined.
Basic objectives2
Others
Basic objectives -Others
Implementation Practicality Acceptability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Low back and pelvic pain NRS scores at 8 weeks after the start of the program
Key secondary outcomes
1.Degree of daily disability at 8weeks after the start of the program (Oswestry Low Back Pain Disability Questionnaire:ODI)and Change in ODI score
2.Degree of depressive symptoms at 8weeks after the start of the program (Edinburgh Postpartum Depression Questionnaire:EPDS) and Change in EPDS score
3.Continuation of Yoga Implementation Number of days of yoga practice and Average daily yoga practice time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Pregnant woman with back and pelvic pain due to pregnancy to do yoga for self-care for 8 weeks. Perform 2 online sessions of yoga. Keep a pain diary.
Interventions/Control_2
Yoga in self-care using yoga leaflets.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) Pregnant women between 26 and 30 weeks gestation with back or pelvic pain due to pregnancy
2) Single pregnancy
3) 20 years of age or older
4) No abnormalities in the course of pregnancy or fetal growth
5) Non-pregnant BMI less than 35
6) Able to understand, read and write Japanese
Key exclusion criteria
1) Pregnant women with obstetric abnormalities or obstetric complications, such as cardiac or respiratory disease, for which exercise during pregnancy is contraindicated
2) Pregnant women who have had back pain or pelvic pain prior to this pregnancy
3) Pregnant women who have had or are currently undergoing treatment for malignancy, infection, fracture, lumbar spine disease, or internal organ disease that causes back pain
4) Pregnant women who are undergoing or will undergo specialized treatment for low back pain or pelvic pain
5) Pregnant women who have a mental illness during this pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | EMI |
| Middle name | |
| Last name | MASUDA |
Organization
St.Luke's International University,Graduate School
Division name
Nursing science
Zip code
104-0044
Address
10-1,Akashi-cho,Chuo-ku,Tokyo
TEL
03-3543-6391
20dn011@slcn.ac.jp
Public contact
Name of contact person
| 1st name | EMI |
| Middle name | |
| Last name | MASUDA |
Organization
St.Luke's International University,Graduate School
Division name
Nursing science,Doctoral course
Zip code
104-0044
Address
10-1,Akashi-cho,Chuo-ku,Tokyo
TEL
03-3543-6391
Homepage URL
20dn011@slcn.ac.jp
Sponsor or person
Institute
St.Luke's International University
Institute
Department
Personal name
Funding Source
Organization
Japan Academy midwifery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Chiba Prefectural University of Health Sciences
IRB Contact (For public release)
Organization
Research Ethics Committee of St.Luke7s International University
Address
10-1,Akashi-cho,Chuo-ku,Tokyo
Tel
03-5550-2423
kenkyukikaku@luke.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 | 18 | 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
50
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
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 08 | 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 | 12 | Month | 18 | Day |
Last modified on
| 2024 | 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=R000061602
