1. Home
  2. Approved trials
  3. » فارسی

Effect of Eucalyptus oil inhalation on pain and quality of life in patients with rheumatoid arthritis

View the latest revision

History
# Registration date Revision Id
2 2021-10-16, 1400/07/24 201987
1 2018-10-07, 1397/07/15 62220
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    Inclusion criteria: Age is between 18 and 60 years old, Confirmed Diagnosis of MS by a neurologist, Having complete and informed consent to participate in the study. Exclusion criteria: Having allergies; Drug addiction
    Inclusion criteria: Having at least one year of the definitive diagnosis of articular rheumatism, Absence of history of allergy, allergic rhinitis, asthma, and chronic pulmonary disease, No use of aromatherapy in the past month, Having complete and informed consent to participate in the study, Confirmed diagnosis of rheumatoid arthritis by the physician, Age between 18 and 60 years old Exclusion criteria: Allergy to eucalyptus, Changing the disease process, death, The patient migrates to another place
    معیارهای ورود: سن بین 18 تا 60 سال، تایید ابتلا به بیماری ام اس توسط متخصص نورولوژی، داشتن رضایت آگاهانه جهت شرکت در مطالعه. معیارهای عدم ورود: داشتن آلرژی؛ اعتیاد به مواد مخدر
    معیارهای ورود: ابتلا به بیماری روماتیسم مفصلی با تشخیص قطعی حداقل بمدت یکسال، نداشتن سابقه حساسیت، رنیت آلرژیک، آسم و بیماریهای مزمن ریوی، عدم استفاده از رایحه درمانی در یک ماه گذشته، داشتن رضایت کامل آگاهانه جهت شرکت در مطالعه، تایید ابتلا به بیماری آرتریت روماتوئید توسط بزشک، سن بین 18 تا 60 سال معیارهای عدم ورود: ایجاد حساسیت به اکالیپتوس؛ تغییر در فرایند بیماری، مرگ بیمار، مهاجرت بیمار به مکانی دیگر

  • General information

    35
    empty
    empty
    In the inclusion criteria section, instead of patients with rheumatoid arthritis, patients with MS are written.
    empty
    در قسمت معیارهای ورود، بجای بیماران ارتریت روماتوئید، بیماران مبتلا به ام اس نوشته شده است.
    Effect of Inhalation of Eucalyptus Oil on Pain and Quality of Life
    Effect of inhalation of eucalyptus oil on pain and quality of life
    Effect of Eucalyptus Oil Inhalation on Pain and Quality of Life in Patients with Rheumatoid Arthritis
    Effect of Eucalyptus oil inhalation on pain and quality of life in patients with rheumatoid arthritis
    Age between 18 and 60 years old
    Confirmed Diagnosis of MS by the neurologist
    Having complete and informed consent to participate in the study
    Age between 18 and 60 years old
    Confirmed diagnosis of rheumatoid arthritis by the physician
    Having complete and informed consent to participate in the study
    No use of aromatherapy in the past month
    Absence of history of allergy, allergic rhinitis, asthma, and chronic pulmonary disease
    Having at least one year of the definitive diagnosis of articular rheumatism
    سن بین 18 تا 60 سال
    تایید ابتلا به بیماری ام اس توسط نرولوژیست
    داشتن رضایت کامل آگاهانه جهت شرکت در مطالعه
    سن بین 18 تا 60 سال
    تایید ابتلا به بیماری آرتریت روماتوئید توسط بزشک
    داشتن رضایت کامل آگاهانه جهت شرکت در مطالعه
    عدم استفاده از رایحه درمانی در یک ماه گذشته
    نداشتن سابقه حساسیت، رنیت آلرژیک، آسم و بیماریهای مزمن ریوی
    ابتلا به بیماری روماتیسم مفصلی قطعی حداقل بمدت یکسال
    Having allergies
    Drug addiction
    Allergy to eucalyptus
    Changing the disease process
    Death
    The patient migrates to another place
    داشتن آلرژی
    اعتیاد به مواد مخدر
    ایجاد حساسیت به اکالیپتوس
    تغییر در فرایند بیماری
    فوت بیمار
    مهاجرت بیمار به مکانی دیگر

  • Recruitment centers

    #1
    Name of recruitment center - English: Beheshti hospital
    Name of recruitment center - Persian: بیمارستان بهشتی
    Full name of responsible person - English: Arezoo Karampourian
    Full name of responsible person - Persian: آرزو کرمپوریان
    Street address - English: Beheshti St, Beheshti hospital, Hamadan
    Street address - Persian: همدان، خیابان بهشتی، بیمارستان بهشتی
    City - English: hamedan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 38698-65178
    Phone: +98 81 3838 0535
    Fax:
    Email: a.karampourian@umsha.ac.ir
    Web page address:
    Name of recruitment center - English: Beheshti hospital
    Name of recruitment center - Persian: بیمارستان بهشتی
    Full name of responsible person - English: Arezoo Karampourian
    Full name of responsible person - Persian: آرزو کرمپوریان
    Street address - English: Beheshti hospital, Beheshti Street
    Street address - Persian: خیابان بهشتی، بیمارستان بهشتی
    City - English: Hamedan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 38698-65178
    Phone: +98 81 3838 0535
    Fax:
    Email: a.karampourian@umsha.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Saeed Bashirian
    Full name of responsible person - Persian: سعید بشیریان
    Street address - English: Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
    Street address - Persian: همدان، خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان
    City - English: hamedan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 38698-65178
    Phone: +98 81 3838 0535
    Fax:
    Email: s-bashirian@umsha.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Saeed Bashirian
    Full name of responsible person - Persian: سعید بشیریان
    Street address - English: Hamadan University of Medical Sciences, Shahid Fahmideh Street
    Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان
    City - English: Hamedan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 38698-65178
    Phone: +98 81 3838 0535
    Fax:
    Email: s-bashirian@umsha.ac.ir
    Web page address:

Protocol summary

Study aim
The aim of this study was to determine the effect of inhalation of eucalyptus oil on the severity of pain and quality of life in patients with rheumatoid arthritis.
Design
The present study is a randomized clinical trial with two parallel groups which is done on 70 patients.
Settings and conduct
This study will be performed on 70 patients with rheumatoid arthritis admitted to the hospital. In the intervention group, 1 ml of Eucalyptus oil will be inhaled for 5 minutes. In the control group, distilled water will be used. The severity of pain and quality of life in patients will be evaluated using VAS and SF-12 questionnaires within a month.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having at least one year of the definitive diagnosis of articular rheumatism, Absence of history of allergy, allergic rhinitis, asthma, and chronic pulmonary disease, No use of aromatherapy in the past month, Having complete and informed consent to participate in the study, Confirmed diagnosis of rheumatoid arthritis by the physician, Age between 18 and 60 years old Exclusion criteria: Allergy to eucalyptus, Changing the disease process, death, The patient migrates to another place
Intervention groups
In the intervention group: 1 ml of eucalyptus oil is poured on a 4 × 2 inch gas and placed at a distance of 30 cm from the nose of the patients and is inhaled for 5 minutes. The patient's pain will be evaluated using the VAS. In the control group: Except for routine medication and care, no special action will be taken.
Main outcome variables
pain; quality of life

General information

Reason for update
In the inclusion criteria section, instead of patients with rheumatoid arthritis, patients with MS are written.
Acronym
IRCT registration information
IRCT registration number: IRCT20160110025929N15
Registration date: 2018-10-07, 1397/07/15
Registration timing: registered_while_recruiting

Last update: 2021-10-19, 1400/07/27
Update count: 1
Registration date
2018-10-07, 1397/07/15
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Eucalyptus oil inhalation on pain and quality of life in patients with rheumatoid arthritis
Public title
Effect of inhalation of eucalyptus oil on pain and quality of life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 60 years old Confirmed diagnosis of rheumatoid arthritis by the physician Having complete and informed consent to participate in the study No use of aromatherapy in the past month Absence of history of allergy, allergic rhinitis, asthma, and chronic pulmonary disease Having at least one year of the definitive diagnosis of articular rheumatism
Exclusion criteria:
Allergy to eucalyptus Changing the disease process Death The patient migrates to another place
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
70 patients will be selected through available sampling. Then the patients will be assigned to the groups using block randomization method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2018-09-01, 1397/06/10
Ethics committee reference number
IR.UMSHA.REC.1397.408

Health conditions studied

1

Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05.10
ICD-10 code description
Rheumatoid lung disease with rheumatoid arthritis of unspecified site

Primary outcomes

1

Description
Quality of life
Timepoint
Before and after intervention
Method of measurement
SF-12 Questionnaire

2

Description
Pain
Timepoint
Before and after intervention
Method of measurement
Visual Analog Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1 ml of eucalyptus oil is poured on a 4 × 2 inch cloth and placed at a distance of 30 cm from the nose of the patients and inhaled for 5 minutes.
Category
N/A

2

Description
Control group: 1 ml of distilled water is poured on a 4 × 2 inch cloth and placed at a distance of 30 cm from the nose of the patients and inhaled for 5 minutes.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
Arezoo Karampourian
Street address
Beheshti hospital, Beheshti Street
City
Hamedan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
a.karampourian@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamedan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of Research and Technology
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arezoo Karampourian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
a.karampourian@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arezoo Karampourian
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamedan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
a.karampourian@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Kord
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamedan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
zahrakordvarkane955@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...