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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027703
Receipt No. R000031734
Scientific Title An Assessment of the Efficacy of Passive Muscle Relaxation in Healthy Women
Date of disclosure of the study information 2017/08/01
Last modified on 2019/06/11

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Basic information
Public title An Assessment of the Efficacy of Passive Muscle Relaxation in Healthy Women
Acronym An Assessment of the Efficacy of Passive Muscle Relaxation in Healthy Women
Scientific Title An Assessment of the Efficacy of Passive Muscle Relaxation in Healthy Women
Scientific Title:Acronym An Assessment of the Efficacy of Passive Muscle Relaxation in Healthy Women
Region
Japan

Condition
Condition healthy Women
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The present study aimed to assess the efficacy of passive muscle relaxation (PMR) in healthy women
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes salivary amylase
Profile of Mood States
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
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 No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Passive muscle Relaxation
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
20 years-old <=
Age-upper limit
40 years-old >
Gender Female
Key inclusion criteria 1.Women 20 years or older
2.Health does not have disorder
3.We are not taking medicine
4.It is not during menstruation,
5.We do not conduct relaxation in everyday life
Key exclusion criteria Health is defective
We are taking medicine
It is during menstruation
We conduct relaxation in everyday life
Women younger than 20 years
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuka Kondo
Organization Gunma University
Division name Graduate School of Health Science
Zip code
Address 3-29-22 Showa-Machi, Maebashi Gunma,371-8511
TEL 027-220-7111
Email yukondo@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuka Kondo
Organization Gunma University
Division name Graduate School of Health Science
Zip code
Address 3-29-22 Showa-Machi, Maebashi Gunma,371-8511
TEL 027-220-7111
Homepage URL
Email yukondo@gunma-u.ac.jp

Sponsor
Institute Gunma University
Graduate School of Health Science
Institute
Department

Funding Source
Organization Gunma University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 08 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 No longer recruiting
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
2017 Year 05 Month 19 Day
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2024 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
2017 Year 06 Month 09 Day
Last modified on
2019 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031734

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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