Protocol summary

Study aim
The Effect of Aromatherapy with Lavender and damask rose on Obvious Anxiety Level of the endoscopy Candidate Patients
Design
clinical trial with a control group,with factorial groups, single-blind, randomized
Settings and conduct
The researcher refers to the research environment, With informed consent, eligible patients enter the study. Demographic questionnaire and anxiety are completed. Then, depending on which patient is located(lottery), intervention is performed. One hour before endoscopy, in the group, 2drops of 10% lavender oil are placed on a cotton ball and attached to the patient's collar with a pin and the patient is asked To breathe normally for 30 minutes. In the group2, the same intervention is performed with 2drops of oil of damask rose. In the control group, the same intervention was performed with two drops of odorless soy oil(placebo). Then again, the situational anxiety questionnaire is completed for all three groups after the intervention. All actions are done by a researcher. The study is single-blind, and patients are not informed of any of the study groups and their differences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age >=18, full awareness, interested in participating in the study, able to understand and speak Persian, endoscopy for the first time, and lack of Psychological and anxiety disease, mental retardation, blindness and deafness, history of allergies to plants, migraine and chronic headache, olfactory disorder, anxiety and narcotic drugs, and history of severe psychological stress recently. Exclusion criteria: emergency endoscopy, acute pain at the time of completing the questionnaire.
Intervention groups
Group1 aromatherapy with lavender Group2 aromatherapy with damask rose Control group aromatherapy with two drops of odorless soy oil(placebo)
Main outcome variables
Anxiety score Control; Use of non-pharmacological methods

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180303038934N1
Registration date: 2018-10-13, 1397/07/21
Registration timing: registered_while_recruiting

Last update: 2018-10-13, 1397/07/21
Update count: 0
Registration date
2018-10-13, 1397/07/21
Registrant information
Name
Arezoo Monfared
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 5058
Email address
a.monfared@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparative study on the Effect of Aromatherapy with Lavender and damask rose on Obvious Anxiety Level of the endoscopy Candidate Patients
Public title
The Comparative study on the Effect of Aromatherapy with Lavender and damask rose on Obvious Anxiety Level of the endoscopy Candidate Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be alert (relative to location, time, and surrounding) Gastrointestinal endoscopy for the first time. Not mental illness and anxiety, mental retardation, blindness and deafness. any disorder have not sense of smell. Do not use anti-anxiety and opioid drugs There is no history of severe psychological stress during endoscopy (such as relatives death ).
Exclusion criteria:
Acute pain when completing the questionnaire.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be drawn by lottery and will be randomly assigned to the studied groups. After reviewing the eligible patients, they will be satisfied. A draw box in which there are three paper with numbers 1, 2 and 3 in it is provided to the patient to randomly remove a number. That number represents the group in which it is placed. If the number of samples of each group is completed, that number will be withdrawn from the lottery container. This will continue to the required number of samples for all three groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
All actions, including the completion of questionnaires and the use of essential oils, are done by a researcher and the study is single blind, and the patients in all three groups are not informed of any of the groups studied and their differences. But the researcher is aware of the difference in groups and essential oils due to the categorization of the patients in the three groups and the implementation of the intervention.
Placebo
Used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
In Front of the 17 Shahrivar Hospital .,Seiadati Ave., Namjo Ave., Rasht City
City
Rasht
Province
Guilan
Postal code
39841-41469
Approval date
2018-01-27, 1396/11/07
Ethics committee reference number
IR.GUMS.REC :1395.462

Health conditions studied

1

Description of health condition studied
Upper gastrointestinal endoscopy
ICD-10 code
K25
ICD-10 code description
Gastric ulcer

2

Description of health condition studied
anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

Primary outcomes

1

Description
Spielberger state anxiety score; score of 21-39 indicates mild anxiety, 40-59 average anxiety and 60-80severe anxiety
Timepoint
The beginning of the study (before the intervention) and the end of the intervention, the questionnaire will be completed
Method of measurement
Spielberger state anxiety Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: One hour before endoscopy, two drops of 10% lavender essential oil (the product of Barij Essen Company) are placed on a cotton ball and attached to the patient's collar with a pin. The patient is asked to wait for 30 minutes Take a normal breath.
Category
Treatment - Drugs

2

Description
Intervention group 2: One hour before the patient goes to endoscopy, two drops of Damask Rose essential oil with a concentration of 10% (the product of Barij Essen Company) are placed on a cotton ball and attached to the patient's collar by the pin. They are asked to breathe normally for 30 minutes.
Category
Treatment - Drugs

3

Description
Control group: One hour before the patient goes to endoscopy, two drops of odorless soy oil (placebo) with a concentration of 10% (the product of Barij Essen Company) are placed on a cotton ball and attached to the patient's collar by the pin. They are asked to breathe normally for 30 minutes.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Educational and Therapeutic Center of Rasht
Full name of responsible person
Maryam Mirzaee
Street address
Razi Educational and Therapeutic Center., Sardar Jangal St., Rasht
City
Rasht
Province
Guilan
Postal code
41448
Phone
+98 13 3355 0028
Fax
+98 13 3355 0097
Email
a.monfared88@gmail.com
Web page address
http://www.gums.ac.ir/razi/444/%D8%B5%D9%81%D8%AD%D9%87-%D8%A7%D8%B5%D9%84%DB%8C.aspx

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Shadman Nemati
Street address
In Front of 17 Shahrivar Hospital., Siadati Ave., Namjo Ave., Rasht
City
Rasht
Province
Guilan
Postal code
1873- 41635
Phone
+98 13 3333 6394
Email
nemati@gums.ac.ir
Web page address
http://www.gums.ac.ir/research/303/%D8%B5%D9%81%D8%AD%D9%87-%D8%A7%D8%B5%D9%84%DB%8C.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
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
Rasht University of Medical Sciences
Full name of responsible person
Maryam Mirzaee
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Student Ave., Shahid Beheshti Blu., Rasht
City
Rasht
Province
Guilan
Postal code
1873- 41635
Phone
+98 13 3355 5056
Email
msnurse_mirzaee@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Maryam Mirzaee
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Student Ave., Shahid Beheshti Blu., Rasht
City
Rasht
Province
Guilan
Postal code
1873- 41635
Phone
+98 13 3355 5056
Email
msnurse_mirzaee@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Maryam Mirzaee
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Student Ave., Shahid Beheshti Blu., Rasht
City
Rasht
Province
Guilan
Postal code
1873- 41635
Phone
+98 13 3355 5056
Email
a.monfared88@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Based on the goals in the design, the amount of anxiety is reported before and after the aromatherapy and some of the individual information listed in the Variables section
When the data will become available and for how long
Starting from the second half of 2019
To whom data/document is available
Researchers, Guilan University of Medical Sciences, samples of study, University and Hospital Researchers
Under which criteria data/document could be used
Data after analysis, is available to others through publication in scientific journals
From where data/document is obtainable
maryam mirzaee and Arezoo monfared Email : msnurse_mirzaee@yahoo.com Address: Student Ave., Shahid Beheshti Blu., Rasht, Iran Postal code: 41635- 1873 Tel: +98 13 3355 5056 Tel: +98 911 766 3251
What processes are involved for a request to access data/document
Usually, information will be available through the publication of the paper. But if the person asks for more and more information, can submit application by email and phone and in person. Then information will be provided according to the size and type of data that will be considered.
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