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: 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
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
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N15
Registration date:2018-10-07, 1397/07/15
Registration timing:registered_while_recruiting
Last update:2018-10-07, 1397/07/15
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 MS by the neurologist
Having complete and informed consent to participate in the study
Exclusion criteria:
Having allergies
Drug addiction
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
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
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 St, Beheshti hospital, Hamadan
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
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
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