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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025115
Receipt No. R000028876
Scientific Title Effects of relaxation by environmental adjustment
Date of disclosure of the study information 2017/01/10
Last modified on 2018/12/06

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Basic information
Public title Effects of relaxation by environmental adjustment
Acronym Effects of relaxation by environmental adjustment
Scientific Title Effects of relaxation by environmental adjustment
Scientific Title:Acronym Effects of relaxation by environmental adjustment
Region
Japan

Condition
Condition Healthy
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate effects of relaxation by environmental adjustment.
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 General health questionnaire, Mood scale, Blood pressure, Pulse, Salivary cortisol

Base
Study type Interventional

Study design
Basic design Parallel
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 In environmental adjustment, Breathing exercises and Guide Imagery, once for each
Interventions/Control_2 Breathing exercises and Guide Imagery, 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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Laborers of general enterprises
Key exclusion criteria Persons with disabilities in sight, hearing or smell
Patient under treatment
Target sample size 160

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 027-220-7111
Email natsuy@gunma-u.ac.jp

Public contact
Name of contact person
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 027-220-7111
Homepage URL
Email natsuy@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 01 Month 10 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 Completed
Date of protocol fixation
2016 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 12 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
2016 Year 12 Month 02 Day
Last modified on
2018 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028876

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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