UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036365 |
|---|---|
| Receipt number | R000041430 |
| Scientific Title | Chronological change of the quantity of heat stimulation and temperature of pre and post self-administered smokeless moxibustion for pregnant women |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2020/03/28 18:08:28 |
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Basic information
Public title
Chronological change of the quantity of heat stimulation and temperature of pre and post self-administered smokeless moxibustion for pregnant women
Acronym
Change of the quantity of heat stimulation and temperature of pre and post self-administered smokeless moxibustion
Scientific Title
Chronological change of the quantity of heat stimulation and temperature of pre and post self-administered smokeless moxibustion for pregnant women
Scientific Title:Acronym
Change of the quantity of heat stimulation and temperature of pre and post self-administered smokeless moxibustion
Region
| Japan |
Condition
Condition
Pregnant women with singleton between 28 and 36 gestation weeks
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To visualize the chronological change of the quantity of heat stimulation as an objective index, and to compare and assess the results of pregnant women and non-pregnant women. To verify the feasibility of the study protocol.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rise in skin temperature and blood flow degree of pre and post moxibustion using the infrared thermography and the blood flow meter
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The right acupuncture point BL67 (Zhiyin in Chinese), which is located close to the outer angle of the little toenail, is stimulated using a smokeless moxibustion stick for 10 minutes.
Interventions/Control_2
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Pregnant women with singleton between 28 and 36 gestation weeks
Japanese women aged 18 years and above, with normal fetal biometry, and with normal progression of pregnancy
Key exclusion criteria
Pregnancy with multiples of twins and beyond; risk of preterm birth (preterm uterine contractions or initial dilatation or shortening of the cervix with a score of 4 on the Bishop scale, and tocolytic therapy); maternal heart or kidney disease; placenta previa; complicated with pregnancy-induced hypertension; prelabor rupture of the membranes; intrauterine growth restriction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Higashihara |
Organization
Saitama Prefectural University
Division name
Department of Nursing
Zip code
343-8540
Address
820 Sannomiya, Koshigaya-shi, Saitama, JAPAN
TEL
048-971-0500
higashihara-akiko@spu.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Higashihara |
Organization
Saitama Prefectural University
Division name
Department of Nursing
Zip code
343-8540
Address
820 Sannomiya, Koshigaya-shi, Saitama, JAPAN
TEL
048-971-0500
Homepage URL
higashihara-akiko@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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
The Institutional Review Board of Saitama Prefectural University, Saitama, Japan
Address
820 Sannomiya, Koshigaya-shi, Saitama, JAPAN
Tel
048-971-0500
N/A
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
埼玉県立大学（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | 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
20
Results
After the moxibustion, skin temperature and blood flow of the BL67 and the femoral region were tending to increase. In addition, the change of the skin temperature after the moxibustion were upward trends until approximately 20 minutes. Successive changes in pregnant and non-pregnant women tended to be similar. The feasibility of the study protocol was confirmed.
Results date posted
| 2020 | Year | 03 | Month | 28 | Day |
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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 01 | Day |
Last modified on
| 2020 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041430
