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The effect of inhaled Rosa damascena (Damask Rose) aromatherapy on the severity of anxiety in adults following lower extremity orthopedic surgery

Protocol summary

Study aim
Analyzing the effect of aromatherapy using rose essential oil on anxiety levels after general anesthesia in ankle bimalleolar fracture surgery.
Design
A clinical trial with a control group, with parallel groups, without blinding, randomized using dice, in two groups of 50 people.
Settings and conduct
This study will be performed on ASA I, and II patients undergoing bimalleolar surgery. After obtaining consent, all patients over 18 who refer to the operating room of Imam Hossein (AS) Hospital in Tehran in 2022-2023 for surgery will be included in the study. Inhalation intervention will be performed 30 minutes before general anesthesia. An anesthesia technician randomly selects one of the groups for the patient with the help of a coin toss.
Participants/Inclusion and exclusion criteria
After the approval of the ethics committee of Shahid Beheshti University of Medical Sciences and after obtaining the informed consent of the patients, all patients over 18 years of age referred to the operating room for ankle bimalleolar surgery were examined. Patients with olfactory dysfunction, allergy to rose, smokers, and those using illicit drugs were excluded from the study.
Intervention groups
In the intervention group, thirty minutes before general anesthesia, three drops of essential oil of rose are poured on a napkin and the patient inhales it for ten minutes at a distance of 10 cm. In the control group, the same method was used, but instead of essential oil, three drops of drinking water will be used.
Main outcome variables
severity of the patient's anxiety after entering recovery, assess the amount of pain and the presence of nausea and vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120910010800N7
Registration date: 2022-11-07, 1401/08/16
Registration timing: prospective

Last update: 2022-11-07, 1401/08/16
Update count: 0
Registration date
2022-11-07, 1401/08/16
Registrant information
Name
Dariush Abtahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2263 2611
Email address
d.abtahi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-11, 1401/09/20
Expected recruitment end date
2023-02-09, 1401/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inhaled Rosa damascena (Damask Rose) aromatherapy on the severity of anxiety in adults following lower extremity orthopedic surgery
Public title
The effect of inhaling rose essential oil on postoperative agitation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA physical status classification I and II Bimalleolar ankle surgery Consent to participate to trial
Exclusion criteria:
Patients using other methods of relaxation Olfactory disorders Allergy to roses Smoking Drug abusers
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected by simple randomization method using a coin toss. In such a way that the selection of the case is done in the case of heads and the selection of control is done in the case of tales.
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
Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me
Street address
Emam Hossein Hospital, Shahid Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2022-10-02, 1401/07/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.472

Health conditions studied

1

Description of health condition studied
bimalleolar ankle surgery
ICD-10 code
S82.84
ICD-10 code description
Bimalleolar fracture of lower leg

Primary outcomes

1

Description
agitation
Timepoint
postoperative, in recovery room
Method of measurement
Observation and self-declaration

Secondary outcomes

1

Description
pain
Timepoint
postoperative, in recovery room
Method of measurement
Pain ruler, visual analog scale

2

Description
postoperative nausea and vomiting
Timepoint
at 24 hours after the end of surgery
Method of measurement
Observation and self-declaration

Intervention groups

1

Description
Intervention group: Thirty minutes before general anesthesia, three drops of 33% rose essential oil (Barij Essential Oil Company) are poured on a cloth and the patient takes it at a distance of ten centimeters and inhales it for ten minutes. The studied variables will be examined in the recovery room.
Category
Prevention

2

Description
Control group: Thirty minutes before general anesthesia, three drops of water are poured on a cloth and the patient takes it at a distance of ten centimeters and inhales it for ten minutes. The studied variables will be examined in the recovery room.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Emam Hossein
Full name of responsible person
Dariush Abtahi
Street address
Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Email
drdariushabtahi@yahoo.com
Web page address
https://www.ehmc.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshhin Zarghi
Street address
Tehran Province, Tehran, Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Web page address
https://en.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dariush Abtahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Hossein Hospital, Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 2263 2611
Fax
Email
d.abtahi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dariush Abtahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Hossein Hospital, Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 2263 2611
Fax
Email
d.abtahi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dariush Abtahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Hossein Hospital, Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 2263 2611
Fax
Email
d.abtahi@sbmu.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identified individuals.
When the data will become available and for how long
One year after the publication of the article.
To whom data/document is available
All jobs
Under which criteria data/document could be used
All non-personal patient information (anonymously) can be accessed by contacting the responsible author.
From where data/document is obtainable
email to: drdariushabtahi@yahoo.com
What processes are involved for a request to access data/document
Sending email and review by the responsible author.
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