Protocol summary

Study aim
The objective of our study is to evaluate aromatherapy with rose oil the effect on preoperative anxiety.
Design
prospective, randomized, controlled, double-blind, parallel group.
Settings and conduct
The patients who will have Septorhinoplasty operation in Ahi Evran University Training and Research Hospital Department of Otorhinolaryngology will be enrollment. The volunteers will be randomized with closed envelope method 1: 1: 1 as the control group (Group C), the sham group (Group S) and the rose oil group (Group R).
Participants/Inclusion and exclusion criteria
The patients who will have Septorhinoplasty operation in Ahi Evran University Training and Research Hospital Department of Otorhinolaryngology will be enrollment. The patients who ASA (American Society of Anesthesiologists) I-II risk group and between the ages of 18-40 will be included in the study. Hypertension, cardiac dysrhythmia, chronic depression and anxiety treatment, allergy to aromatherapy oils, bronchospasm, anosmia are exclusion criteria in this study.
Intervention groups
No application will be made in Group C (Control). In Group S (Sham), a mixture of 25 ml of 2% distilled water and glycerin will be added to the aromatherapy device. In Group R, a mixture of distilled water, glycerin and rose oil,2% 25 ml, will be placed on the aromatherapy device.
Main outcome variables
The first STAI TX-1 (State-Trait Anxiety Inventory) (preop 1 in the clinic and preop 2 in the operating room) test will be performed by a researcher and responses will be recorded in the case report form. Heart rate, systolic-diastolic blood pressure of patients will be measured when patients arrive at the otorhinolaryngology clinic service.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180324039145N1
Registration date: 2018-04-05, 1397/01/16
Registration timing: prospective

Last update: 2018-04-05, 1397/01/16
Update count: 0
Registration date
2018-04-05, 1397/01/16
Registrant information
Name
Recai Dagli
Name of organization / entity
Ahi Evran University Faculty of Medicine
Country
Turkey
Phone
+90 386 213 45 15
Email address
recai.dagli@ahievran.edu.tr
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-01, 1397/03/11
Expected recruitment end date
2018-12-31, 1397/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of aromatherapy using rose oil (Rosa damascena Mill.) on preoperative anxiety: A prospective randomized clinical trial
Public title
Rose oil aromatherapy treatments for preoperative anxiety
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The patients who will have Septorhinoplasty operation ASA (American Society of Anesthesiologists) I-II risk group Between the ages of 18-40
Exclusion criteria:
Hypertension, Cardiac dysrhythmia Chronic depression and anxiety treatment Allergy to aromatherapy oils Bronchospasm Anosmia
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Microsoft Exel random number generator function will be used with blocks of 30 for randomization as the control group (Group C), the sham group (Group S) and the rose oil group (Group R). The volunteers will be randomized with closed envelope method (number of 1-30) as 1: 1: 1 in operation morning. Randomization will be repeated every 30 patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Heart rate, systolic-diastolic blood pressure of patients will be measured when patients arrive at the otorhinolaryngology clinic service. The first STAI TX-1 (State-Trait Anxiety Inventory) (preop 1) test will be performed by a researcher and responses will be recorded in the case report form. The patients do not know which they are groups due to closed envelop method. Aromatherapy will be implemented according to the patient's group by the care provider. The other investigator and outcome assessor will be in the operating room. In the operating room, the second STAI TX-1 test will be performed by the researcher who does not know in which group the volunteers are in the group. Preoperative heart rate, systolic-diastolic blood pressure of patients will be measured and recorded as preop 2.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahi Evran University Clinical Investigations Ethics Committee
Street address
Bagbasi Mh.
City
Kirsehir
Postal code
40100
Approval date
2017-10-31, 1396/08/09
Ethics committee reference number
(Decision Number:2017-16-192)

Health conditions studied

1

Description of health condition studied
Preoperative anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
The first STAI TX-1 (State-Trait Anxiety Inventory) (preop 1) test will be performed by a researcher and responses will be recorded in the case report form.
Timepoint
In the operating room, the second STAI TX-1 test will be performed by the researcher who does not know in which group the volunteers are in the group.
Method of measurement
STAI TX-1 (State-Trait Anxiety Inventory) test

2

Description
Heart rate, systolic-diastolic blood pressure of patients will be measured when patients arrive at the otorhinolaryngology clinic service.
Timepoint
In the operating room, preoperative heart rate, systolic-diastolic blood pressure of patients will be measured and recorded as preop 2.
Method of measurement
Blood pressure using sphygmomonometer , heart rate using ECG

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: rose oil group (Group R)
Category
Treatment - Other

2

Description
Intervention group: the sham group (Group S)
Category
Placebo

3

Description
Control group: the control group (Group C)
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahi Evran University Training and Research Hospital Department of Otorhinolaryngology
Full name of responsible person
Mehmet Metin
Street address
Kervansaray Mh.
City
Kirsehir
Postal code
40200
Phone
+90 386 213 45 15
Email
drmehmetmetin@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahi Evran University Training and Research Hospital Department of Otorhinolaryngology
Full name of responsible person
Mustafa Avcu
Street address
Kervansaray
City
Kirsehir
Postal code
40100
Phone
+90 386 213 45 15
Email
dravcu@yahoo.com.tr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahi Evran University Training and Research Hospital Department of Otorhinolaryngology
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Ahi Evran University
Full name of responsible person
Recai Dagli
Position
Assistant proffessor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kervansaray Mh.
City
Kirsehir
Province
Kirsehir
Postal code
40100
Phone
+90 386 213 45 15
Email
recai.dagli@ahievran.edu.tr

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahi Evran University
Full name of responsible person
Mehmet Metin
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Kervansaray
City
Kirsehir
Province
Kirsehir
Postal code
40100
Phone
+90 386 213 45 15
Email
drmehmetmetin@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahi Evran University Faculty of Medicine
Full name of responsible person
Recai Dagli
Position
Ass.Prof.Dr.
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bagbasi street.
City
Kirsehir
Province
Kirsehir
Postal code
40100
Phone
+90 386 213 45 15
Fax
Email
recai.dagli@ahievran.edu.tr

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
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be shared by the open access manuscript.And the corresponding author can send all data or documents by e-mail.
When the data will become available and for how long
All data will be shared by the open access manuscript.And the corresponding author can send all data or documents by e-mail.
To whom data/document is available
All data will be shared by the open access manuscript.
Under which criteria data/document could be used
All data will be shared by the open access manuscript.And the corresponding author can send all data or documents by e-mail.
From where data/document is obtainable
All data will be shared by the open access manuscript.And the corresponding author can send all data or documents by e-mail.
What processes are involved for a request to access data/document
All data will be shared by the open access manuscript.And the corresponding author can send all data or documents by e-mail.
Comments
All data will be shared by the open access manuscript. And the corresponding author can send all data or documents by e-mail.
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