UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000036365
Receipt No. 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 (Ver. 5)

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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
Obsterics 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
Email 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
Email higashihara-akiko@spu.ac.jp

Sponsor
Institute Saitama Prefectural University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041430