UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028024
Receipt No. 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

* 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 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
Email 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
Email m14202079@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032089

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.