UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028024 |
|---|---|
| Receipt number | R000032089 |
| Scientific Title | Assessment of the physiological and subjective response by the progressive muscle relaxation with eyes opened or closed |
| Date of disclosure of the study information | 2017/07/05 |
| Last modified on | 2018/01/04 13:17:49 |
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Basic information
Public title
Assessment of the physiological and subjective response by the progressive muscle relaxation with eyes opened or closed
Acronym
Assessment of the physiological and subjective response by the progressive muscle relaxation with eyes opened or closed
Scientific Title
Assessment of the physiological and subjective response by the progressive muscle relaxation with eyes opened or closed
Scientific Title:Acronym
Assessment of the physiological and subjective response by the progressive muscle relaxation with eyes opened or closed
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify effects and differences of the physiological and subjective response by the progressive muscle relaxation with eyes opened or closed and investigate the usefulness of the progressive muscle relaxation with the eyes closed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate variability before and after intervention
Key secondary outcomes
Pulse, Blood pressure, Salivary amylase activity, Profile of Mood States-Brief Form Japanese Version, freedom described
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The progressive muscle relaxation with eyes opened, once for each
Interventions/Control_2
The progressive muscle relaxation with eyes closed, once for each
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
| 23 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy males aged 18 to 24 years old
Key exclusion criteria
Persons with insomnia-like, a loss of appetite, other symptoms
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Natsuko Yanagi |
Organization
Gunma University
Division name
Graduate school of health science
Zip code
Address
3-39-22, Showa-machi, Maebashi, Gunma
TEL
027-220-8981
natsuy@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yui Yamamoto |
Organization
Gunma University
Division name
School of health science
Zip code
Address
3-39-22, Showa-machi, Maebashi, Gunma
TEL
080-2552-0854
Homepage URL
m14202079@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
An alumni association of 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
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 | 07 | Month | 05 | 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
Main results already published
Date of protocol fixation
| 2017 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 10 | Day |
Last follow-up date
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 | 30 | Day |
Last modified on
| 2018 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032089
