UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025115
Receipt number 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 08:06:29

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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 or person

Institute

Gunma University

Institute

Department

Personal name



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

Value
https://center6.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