UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038607
Receipt number R000044001
Scientific Title The effects of agarwood's (Jin-kou's) scents to autonomic nervous system of female nurses after night shifts: a double-blind randomized controlled crossover study
Date of disclosure of the study information 2019/11/19
Last modified on 2019/11/29 13:30:37

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Basic information

Public title

The effects of agarwood's (Jin-kou's) scents to autonomic nervous system of female nurses after night shifts: a single-blind randomized controlled crossover study

Acronym

The effects of agarwood's (Jin-kou's) scents to autonomic nervous system

Scientific Title

The effects of agarwood's (Jin-kou's) scents to autonomic nervous system of female nurses after night shifts: a double-blind randomized controlled crossover study

Scientific Title:Acronym

The effects of agarwood's (Jin-kou's) scents to autonomic nervous system

Region

Japan


Condition

Condition

nurse

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of scents of agarwood's (Jin-kou's) scents on female nurses' stress relief who after night shifts.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Parasympathetic nerve system activity

Key secondary outcomes

Sympathetic nerve system activity
Cortisol in saliva
VAS(Visual Analog Scale)
Profile of Mood States-Brief Form 2nd Edition
Perceived Stress Scale(PSS)
Japanese version of the Professional Quality of Life Scale(ProQol)
The Hospital Anxiety and Depression Scale(HADS)
Japanese version of the Pittsburgh Sleep Quality Index(PSQI-J)


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Agarwood (Jin-kou)

Interventions/Control_2

Placebo (Non-intervention)

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

60 years-old >

Gender

Female

Key inclusion criteria

(1)female nurses after night shifts
(2)Aged 20 years old or older but younger than 60 years old

Key exclusion criteria

(1)Person who has pulmonary disease, cardiovascular disease, olfactory disorder, or who are under treatment
(2)Person who has experienced the allergic symptoms such as headaches or dermatitis by medication or aromatics

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Kohzuki

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Internal Medicine and Rehabilitation Science

Zip code

980-8574

Address

1-1 Seiryo-cho, Aoba-ku Sendai

TEL

022-717-7353

Email

kohzuki@med.tohoku.ac.jp


Public contact

Name of contact person

1st name JIE
Middle name
Last name LI

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Internal Medicine and Rehabilitation Science

Zip code

980-8574

Address

1-1 Seiryo-cho, Aoba-ku Sendai

TEL

022-717-7353

Homepage URL


Email

li.jie.t2@dc.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Nippon Kodo CO.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

nstitutional Review Board, Graduate school of Medicine, Tohoku University

Address

2-1 Seiryo-cho, Aoba-ku Sendai

Tel

81-22-717-8007

Email

med-kenkyo@grp.tohoku.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

2019 Year 11 Month 19 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

2019 Year 10 Month 11 Day

Date of IRB


Anticipated trial start date

2019 Year 11 Month 25 Day

Last follow-up date

2022 Year 10 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

2019 Year 11 Month 18 Day

Last modified on

2019 Year 11 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044001


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name