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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037619
Receipt No. R000042830
Scientific Title Effects of plantar skin stimulation on sleep and menstrual symptoms
Date of disclosure of the study information 2021/03/31
Last modified on 2021/08/10

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Basic information
Public title Effects of plantar skin stimulation on sleep and menstrual symptoms
Acronym Effects of plantar skin stimulation on sleep and menstrual symptoms
Scientific Title Effects of plantar skin stimulation on sleep and menstrual symptoms
Scientific Title:Acronym Effects of plantar skin stimulation on sleep and menstrual symptoms
Region
Japan

Condition
Condition insomnia
Premenstrual syndrome
Classification by specialty
Medicine in general Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we will investigate whether continuous sleep control by self-care can improve symptoms for menstrual symptoms such as premenstrual syndrome and dysmenorrhea that appear in conjunction with the female sexual cycle. Although various treatments have been performed for menstruation-related symptoms, we thought that it would be possible to improve the symptoms by improving sleep, which is the basis of life activities.
A preliminary survey has shown a correlation between PMS and sleep.
And when we chose the method of sticking non-invasive micro-protrusions to the acupuncture point that is effective for sleep in the sole, we reported that it might be useful for sleep onset and sleep maintenance.
Here, we decided to study the relationship between sleep and menstruation using noninvasive microprotrusions.There are many methods for clinical research of hemorrhoids in research institutes, especially for students, and there is a lot of skepticism about clinical feasibility because of large bias. In this study, we will seek out cooperation with external organizations centered on female acupuncturists, and case studies will be conducted by multicenter clinical institutions. Multi-institutional clinical research by the general hospital is very rare, and the design itself is revolutionary for the acupuncture industry.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Pittsburgh Sleep Quality Index
Menstrual Distress Questionnaire
Key secondary outcomes sleep log

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Non-invasive microprotrusions
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
20 years-old <=
Age-upper limit
40 years-old >=
Gender Female
Key inclusion criteria There is a monthly menstrual period and the menstrual cycle is within the normal range.
Person with MDQ high price with menstrual symptoms
Person who has regular sleep habit but PSQI 10 points or more
Key exclusion criteria Person with unstable sexual cycle
Those who are under the supervision of a doctor in the field of gynecology
Person who receives prescription of sleeping pill by doctor
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Nao
Middle name
Last name Horikawa
Organization Morinomiya University of Medical Sciences
Division name Faculty of Health and Medical Sciences
Zip code 559-8611
Address 1-26-16 Nankokita,Suminoe-ku,Osaka-shi,Osaka
TEL 06-6616-6911
Email horikawa@morinomiya-u.ac.jp

Public contact
Name of contact person
1st name Nao
Middle name
Last name Horikawa
Organization Morinomiya University of Medical Sciences
Division name Faculty of Health and Medical Sciences
Zip code 559-8611
Address 1-26-16 Nankokita,Suminoe-ku,Osaka-shi,Osaka
TEL 0666166911
Homepage URL
Email horikawa@morinomiya-u.ac.jp

Sponsor
Institute Morinomiya University of Medical Sciences
Institute
Department

Funding Source
Organization Morinomiya University of Medical Sciences
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Women's oriental Medical Forum
Name of secondary funder(s)

IRB Contact (For public release)
Organization Morinomiya University of Medical Sciences
Address 1-26-16 Nankokita,Suminoe-ku,Osaka-shi,Osaka
Tel 06-6616-6911
Email horikawa@morinomiya-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
2021 Year 03 Month 31 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 Open public recruiting
Date of protocol fixation
2019 Year 08 Month 01 Day
Date of IRB
2019 Year 08 Month 06 Day
Anticipated trial start date
2019 Year 08 Month 30 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Due to the spread of the new coronavirus infection, it is difficult to recruit subjects.

Management information
Registered date
2019 Year 08 Month 07 Day
Last modified on
2021 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042830

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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