UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025394
Receipt number R000029233
Scientific Title The effects of living environment on recovery profile and stress response in critically ill patients
Date of disclosure of the study information 2017/01/01
Last modified on 2020/06/26 10:09:08

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Basic information

Public title

The effects of living environment on recovery profile and stress response in critically ill patients

Acronym

Living environment in ICU

Scientific Title

The effects of living environment on recovery profile and stress response in critically ill patients

Scientific Title:Acronym

Living environment in ICU

Region

Japan


Condition

Condition

critical ill patients

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether living environment in ICU can affect stress response and recovery profile in critically ill patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

VAS for stress, salivary alpha amylase, RR varability, progression of rehabilitation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

5

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

sense of vision:decoration

Interventions/Control_2

olfaction:aromatherapy

Interventions/Control_3

tactile sensation:massage

Interventions/Control_4

auditory sense:music

Interventions/Control_5

gustatory sensation:meal

Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

15 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

non

Key exclusion criteria

non

Target sample size

120


Research contact person

Name of lead principal investigator

1st name SATOKI
Middle name
Last name INOUE

Organization

Nara Medical University

Division name

Division of Intensive Care

Zip code

634-8521

Address

840 Shijo-cho Kashihara Nara Japan

TEL

0744223051

Email

seninoue@naramed-u.ac.jp


Public contact

Name of contact person

1st name SATOKI
Middle name
Last name INOUE

Organization

Nara Medical University

Division name

Division of Intensive Care

Zip code

634-8521

Address

840 Shijo-cho Kashihara Nara Japan

TEL

0744223051

Homepage URL


Email

seninoue@naramed-u.ac.jp


Sponsor or person

Institute

Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nara Medical University

Address

840 Shijo-cho Kashihara Nara 6348521 Japan

Tel

07442230515276

Email

ino_rinri@naramed-u.ac.jp


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 01 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

Preinitiation

Date of protocol fixation

2017 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 02 Month 15 Day

Last follow-up date

2030 Year 12 Month 31 Day

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 23 Day

Last modified on

2020 Year 06 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029233


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name