UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043102
Receipt number R000049123
Scientific Title A clinical study to examine the psychological effects of aromatherapy in smoking cessation treatment for smokers with neurosis and depression
Date of disclosure of the study information 2021/02/01
Last modified on 2023/01/25 23:40:49

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Basic information

Public title

A clinical study to examine the psychological effects of aromatherapy in smoking cessation treatment for smokers with neurosis and depression

Acronym

Aromatherapy for Smoking Cessation

Scientific Title

A clinical study to examine the psychological effects of aromatherapy in smoking cessation treatment for smokers with neurosis and depression

Scientific Title:Acronym

The Effects of Aromatherapy in Smoking Cessation treatment

Region

Japan


Condition

Condition

nicotine dependence

Classification by specialty

Cardiology Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of aromatherapy in smoking cessation treatment for smokers with neurosis and depression.

Basic objectives2

Others

Basic objectives -Others

Developing a smoking cessation treatment program using aromatherapy.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Change in SDS and POMS scores from the start of therapy to 4weeks and 12weeks later

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Inhalation of Aroma essential oil by inhaler during treatment period

Interventions/Control_2


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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. Individuals with high nicotine dependency (FTND score >= 5 points) who consulted to the smoking cessation clinic to receive treatment
2. Individuals of neurosis, the depressed mental state and SDS tests are 39 points or more and 54 points or less.
3. Individuals not receiving medication on psychiatry, psychosomatic medicine.
4. Outpatients
etc

Key exclusion criteria

1. Inappropriate for the use of Aromatherapy
2. Habitually Aromatherapy user
3. Olfactory impairment
4. Past history of epilepsy
5. Mental disease under medication.
6. Drug allergy with persistent symptom
7. Pregnant, lactating, want to get pregnant
8. Judged as inappropriate for the study by primary physician

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Akiko
Middle name
Last name Hata

Organization

National Hospital Organization, Kyoto Medical Center

Division name

Division of Translational Research

Zip code

612-8555

Address

1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto

TEL

075-641-9161

Email

ako0717@gmail.com


Public contact

Name of contact person

1st name Akiko
Middle name
Last name Hata

Organization

National Hospital Organization, Kyoto Medical Center

Division name

Division of Translational Research

Zip code

612-8555

Address

1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto

TEL

075-641-2270

Homepage URL


Email

ako0717@gmail.com


Sponsor or person

Institute

Clinical Research Institute, National Hospital Organization, Kyoto Medical Center

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization operating support funds

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

National Hospital Organization, Kyoto Medical Center

Address

1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto

Tel

075-641-9161

Email

ako0717@gmail.com


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

2021 Year 02 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

No longer recruiting

Date of protocol fixation

2019 Year 05 Month 17 Day

Date of IRB

2019 Year 06 Month 17 Day

Anticipated trial start date

2019 Year 07 Month 01 Day

Last follow-up date

2023 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 01 Month 22 Day

Last modified on

2023 Year 01 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049123


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name