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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
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
1
-
Sponsor
-
-
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
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