UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027703 |
|---|---|
| Receipt number | 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 | 2022/06/13 09:05:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Yuka |
| Middle name | |
| Last name | Kondo |
Organization
Gunma University
Division name
Graduate School of Health Science
Zip code
371-8511
Address
3-29-22 Showa-Machi, Maebashi Gunma,371-8511
TEL
027-220-7111
yukondo@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Kondo |
Organization
Gunma University
Division name
Graduate School of Health Science
Zip code
3718511
Address
3-29-22 Showa-Machi, Maebashi Gunma,371-8511
TEL
027-220-7111
Homepage URL
yukondo@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Graduate School of Health Science
Institute
Department
Personal name
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
Gunma University
Address
Mabashi City, Showamachi2-39-22
Tel
0272208982
yukondo@gunma-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
| 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
40
Results
A total of 40 subjects, whose average age was 22.1(SD,3.5)years. sAA values:With regard to changes over time following stress tests and immediately after interventions, a significant decline (p=0.008)was observed in the passive muscle relaxation experiment, while no significant decline was observed(p=0.502)in the control experiment.
Results date posted
| 2020 | Year | 12 | Month | 11 | 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
| 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
| 2022 | Year | 06 | Month | 20 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 20 | Day |
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
| 2022 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031734
