UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of relaxation by environmental adjustment
Title of the study (Brief title)	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	Natsuko Yanagi
Organization	Gunma University
Division name	Graduate school of health science
Address	3-39-22 Showa-machi, Maebashi Gunma
TEL	027-220-7111
Email	natsuy@gunma-u.ac.jp

Public contact
Name of contact person	Natsuko Yanagi
Organization	Gunma University
Division name	Graduate school of health science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000028876