The purpose of this study is to Comparison the effect of aromatherapy with lavender and rose on anxiety before surgery. Inclusion criteria are do not using of other anxiety reduction methods and no history of eczema and allergy to plants and no disorder in smell. Exclusion criteria are request to withdraw from the study at any stage and the occurrence of any effects indicating an allergic reaction to the essential used oils. In this clinical trial 135 patients will be selected according to the inclusion criteria and randomly assigned nine-point reversal blocks to three groups of placebo, lavender and red rose (45 subjects each group). In inhaled aromatherapy groups, two drops of essential oils of each plant will be placed on a cloth and the patient will be inhaled from a distance of 7-10 cm and kept for 20 minutes. In the placebo group, two drops of water will be placed on a tissue and similar to the previous two groups, the patient will be inhaled. Immediately before and after the intervention, the mean anxiety score will be determined using the Spielberger standard anxiety questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017092136309N1
Registration date:2017-10-21, 1396/07/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-21, 1396/07/29
Registrant information
Name
Hossein Jeddi
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 5027
Email address
h.jeddi@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Gonabad University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of aromatherapy with lavender and rose on anxiety before surgery
Public title
The effect of aromatherapy on anxiety before surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: do not using of other anxiety reduction methods; no history of eczema and allergy to plants; no disorder in smell. Exclusion criteria: request to withdraw from the study at any stage; the occurrence of any effects indicating an allergic reaction to the essential used oils.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
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 Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of
City
Gonabad
Postal code
Approval date
2016-07-20, 1395/04/30
Ethics committee reference number
GMU.REC.1395.43
Health conditions studied
1
Description of health condition studied
Anxiety before surgery
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Immediately before and after the intervention
Method of measurement
The Spielberger standard instrument (STAI) is widely used by psychologists, specialists and researchers. The credibility and reliability of the Persian translation of that has been reviewed and approved by faculty members of the Shahid Beheshti University of Tehran.
Secondary outcomes
empty
Intervention groups
1
Description
In inhaled aromatherapy red rose groups, two drops of essential oils of red rose will be placed on a cloth and the patient will be inhaled from a distance of 7-10 cm and kept for 20 minutes. Immediately before and after the intervention, the mean anxiety score will be determined using the Spielberger standard anxiety questionnaire.
Category
Treatment - Other
2
Description
In inhaled aromatherapy lavender groups, two drops of essential oils of lavender will be placed on a cloth and the patient will be inhaled from a distance of 7-10 cm and kept for 20 minutes. Immediately before and after the intervention, the mean anxiety score will be determined using the Spielberger standard anxiety questionnaire.
Category
Treatment - Drugs
3
Description
In the placebo group, two drops of water will be placed on a cloth and the patient will be inhaled from a distance of 7-10 cm and kept for 20 minutes. Immediately before and after the intervention, the mean anxiety score will be determined using the Spielberger standard anxiety questionnaire. .
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The 15 khordad hospital
Full name of responsible person
Street address
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadpour
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Hossein Jeddi
Position
BSc in nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
h.jeddi@gmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Samane Najafi
Position
MSc in nursing education
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
Najafi.s@gmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Hossein Jeddi
Position
BSc in nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
h.jeddi@gmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)