Compare the efficacy of aromatherapy with essential oils of lavender and Citrus aurantium on anxiety before laparoscopic surgery In two intervention group and a control group.
The aim of this study is to compare the effect of two methods of aromatherapy; Lavender and citrus aurantium essence; on severity of anxiety before undergoing a Laparoscopic cholecystectomy surgery, in which patients, based on inclusion and exclusion criteria, will be divided in three groups; intervention with Lavender essence, citrus aurantium essence, and control. This study is a single-blind clinical trial that will be conducted on 90 patients. Before intervention, patients must fill out Spiel-Berger anxiety-measuring questionnaire to record basic anxiety. the patients who get 20 (minimum mark) will be entered the study. Then in intervention group, we pour two drops of Lavender essence and citrus aurantium essence by a dropper on a piece of tissue and let the patients to smell it for 20 minutes. After that by Spiel-Berger questionnaire, patients’ anxiety will be measured, finally, the effects of the essences will be studied.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017031433083N1
Registration date:2017-06-26, 1396/04/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-26, 1396/04/05
Registrant information
Name
Abed Ebrahimi
Name of organization / entity
Fatemeh(P.U.H) School of Nursing & Midwifery Shiraz -Iran
Country
Iran (Islamic Republic of)
Phone
+98 77 3542 5315
Email address
mhasanshah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-05-19, 1396/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the efficacy of aromatherapy with essential oils of lavender and Citrus aurantium on anxiety before laparoscopic surgery In two intervention group and a control group.
Public title
Comparison of the effect of aromatherapy with essential oils of lavender and Citrus aurantium on anxiety.
Purpose
Prevention
Inclusion/Exclusion criteria
Admittance and exit standards
Study entrance standards: male and female 40 years and older patients; patients who are getting (Cholecystectomy) surgery with Laparoscopy method; patients must be conscious; they have not taken sedatives; not used anti-anxiety drugs and herbal medicines; non addicted to drugs (according to the patients’ saying); non-working patient in therapeutic and hygienic jobs; not having any vision, hearing, and olfaction problems according to the patients’ saying; not having severe difficulties; getting a score higher than 20 (light anxiety) after answering to Spill Berger questionnaire; patients having light or normal anxiety; able to think and speak in Persian Language.
Study exit standards: severe pain while completing questionnaire; willing to exit in any level of intervention; patients with having severe anxiety; patients who are getting emergency surgery of Cholecystectomy.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Stratified random sampling method hospital then patients are randomly divided into three groups block.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz- zand Street
City
Shiraz
Postal code
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
IR.SUMS.REC.1395.196
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention and after the intervention in the preoperative
Method of measurement
Questionnaire Spillberger
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group 1: 2 drops of Lavandula oil 100% will Poured on the cloth and would be inhaled in 20 minutes by the patient.
Category
Treatment - Other
2
Description
In the intervention group 2: 2 drops of Citrus aurantium oil 100% will Poured on the cloth and would be inhaled in 20 minutes by the patient.
Category
Treatment - Other
3
Description
In the control group: 2 drops of sweet almond oil will Poured on the cloth and would be inhaled in 20 minutes by the patient.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nemazi Hospital
Full name of responsible person
Jamshid Eslami
Street address
Shiraz - Namaz Square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seid Basir Hashemi
Street address
Shiraz - Namaz Square
City
Shiraz
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 Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Abed Ebrahimi
Position
Master Student Operating Room
Other areas of specialty/work
Street address
Shiraz- Namazi Square
City
shiraz
Postal code
Phone
+98 77 3542 5316
Fax
Email
abed.or90@gmail.com
Web page address
sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Jamshid Eslami
Position
PhD in Curriculum
Other areas of specialty/work
Street address
Shiraz- Namazi Square
City
Shiraz
Postal code
Phone
+98 713647425058
Fax
+98 71 1647 4251
Email
eslamij@sums.ac.ir
Web page address
sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abed Ebrahimi
Position
Master Student Operating Room
Other areas of specialty/work
Street address
Shiraz- Namazi Square
City
Shiraz
Postal code
Phone
+98 77 2842 5316
Fax
Email
abed.or90@gmail.com
Web page address
sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)