The aim of this research is Comparison the effect of orange essential oils aromatherapy on anxiety of hemodialysis patients. subjects had dialysis three times a week and lack of stressful events during the past 6 months
This clinical trial study was accomplished on two groups, so that, 62 hemodialysis patients were randomly in two groups (orange oil, usual care). In the orange oil group, subjects inhaled orange oil by handkerchiefs smeared with one drop orange oil for 15-20 minutes. This method was used three times a week during four weeks. In the usual caring group, the cares that was routine in the hemodialysis ward was done for the subjects. The subjects level of anxiety in two groups was measured and compared before intervention, after first, second, third and fourth weeks of intervention, by Spielberg State-Trait Anxiety Inventory questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112318558N1
Registration date:2012-04-06, 1391/01/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-06, 1391/01/18
Registrant information
Name
Masomeh Kanani khisi
Name of organization / entity
Mashad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1853 9775
Email address
kananim2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashad University of Medical Sciences
Expected recruitment start date
2008-11-21, 1387/09/01
Expected recruitment end date
2009-03-05, 1387/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the effect of aromatherapy with orange essential oils on anxiety of patients undergoing hemodialysis
Public title
The Comparison of the effect orange essential oils on anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: dialysis three times a week; At least 6 months of hemodialysis; lack of stressful events during the past 6 months; lack of sedative drugs or other therapeutic measures (such as the use of vegetable oils, regular exercise) to reduce anxiety before six weeks; no use drug; no history of allergic rhinitis; or respiratory problems and no history of hospitalization or treatment because of other psychiatric disorders
Exclusion criteria:Ashpylberger Anxiety Scale scores were obtained from more than 64 in state anxiety and more than 63 in trait anxiety
Age
From 16 years old to 86 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashad University of Medical Sciences
Street address
Mashad University of Medical Sciences, Daneshgah Street
City
Mashad
Postal code
Approval date
2008-09-27, 1387/07/06
Ethics committee reference number
951
Health conditions studied
1
Description of health condition studied
Anxiety of hemodialysis
ICD-10 code
F40-F48
ICD-10 code description
Neurotic, stress-related and somatoform disorders
Primary outcomes
1
Description
Anxiety
Timepoint
before intervention, after first, second, third and fourth weeks of intervention
In the orange oil group, subjects inhaled orange oil by smeared handkerchiefs with one drop of orange oil for 15-20 minutes. This method was used three times a week during four weeks. The Essential oils produced from the company of Gorgan. This essential oils was analyzed in the laboratory of company by Gas - Chromatography connected to mass pectrometer to ensure purity of essential oils and determine its exact composition. The analysis showed that the major compounds include:
Lymonen (%96.5), Betapynen (%0.37),ALfapynen (%0.3), Myrcen (%0.02).
In the usual caring group, the cares that was routine in the hemodialysis ward was done for the subjects
Category
Treatment - Other
2
Description
The Essential oils produced from the company of Gorgan. This essential oils was analyzed in the laboratory of company by Gas - Chromatography connected to mass pectrometer to ensure purity of essential oils and determine its exact composition. The analysis showed that the major compounds include: Lymonen (%96.5), Betapynen (%0.37),ALfapynen (%0.3), Myrcen (%0.02).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
hemodialysis ward of IMAM REZA hospital
Full name of responsible person
Kanani Khisi Masomeh
Street address
IMAM REZA hospital, Abnsina Street
City
mashad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashad University of Medical Sciences
Full name of responsible person
Afzal Aghaei
Street address
Mashad University of Medical Sciences, Daneshgah Street
City
Mashad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashad University of Medical Sciences
Full name of responsible person
Masomeh Kanani Khisi
Position
Master Of Nursing
Other areas of specialty/work
Street address
Mashad Nursing and Midwifery School, Abnsina Street
City
Mashad
Postal code
Phone
+98 51 1859 1511
Fax
+98 51 1859 1511
Email
kananim2@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashad University of Medical Sciences
Full name of responsible person
SReza Mazlum
Position
PHD Nursing, Faculty Member of Mashad Nursing and Midwifery School
Other areas of specialty/work
Street address
Mashad Nursing and Midwifery School, Abnsina Street
City
Mashad
Postal code
Phone
+98 51 1859 1511
Fax
+98 51 1859 1511
Email
mazlumr@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashad University of Medical Sciences
Full name of responsible person
Masomeh Kanani Khisi
Position
Masterof Nursing
Other areas of specialty/work
Street address
Mashad Nursing and Midwifery School, Abnsina Street
City
Mashad
Postal code
Phone
+98 58 1223 0938
Fax
Email
Kananim2@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)