this study was designed to investigate and compare the effect of inhaled aromatherapy using lavender, rose, and a combination of lavender and rose essential oils on anxiety before surgery in patients undergoing adenotonsillectomy.
Design
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 120 patients. sealedenvelope.com was used for randomization.
Settings and conduct
The study location is Matini Hospital in Kashan.in the inpatient ward, the researcher drops 5 drops of the aromatic product prepared for each patient (blind to the type of essential oil) according to the color code and using a dropper on a non-absorbent tissue and attaches it to the patient's collar at a distance of twenty centimeters from the participants' noses. It is recommended that they inhale it normally for 15 minutes. After fifteen minutes, upon entering the operating room and separating from their parents, and then during the anesthesia process, the Yale Anxiety Questionnaire will be completed by an independent researcher who is unaware of the type of essential oil, and physiological indicators will also be measured and recorded.
Participants/Inclusion and exclusion criteria
No history of previous surgery or anesthesia
No history of allergic rhinitis,
No history of respiratory and skin allergies in the child and mother,
No chronic pain in the child
No long-term history of digestive problems
Accompanying a first-degree parent
Informed consent to participate in the study
Exclusion criteria include the following:
Lack of cooperation during the study.
Occurrence of allergic symptoms during the intervention process
Intervention groups
Aromatherapy group with lavender essential oil
Aromatherapy group with rose essential oil
Aromatherapy group with combined lavender and rose essential oil
Control group
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240419061523N3
Registration date:2026-04-29, 1405/02/09
Registration timing:prospective
Last update:2026-04-29, 1405/02/09
Update count:0
Registration date
2026-04-29, 1405/02/09
Registrant information
Name
Nahid Norouzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5510 3142
Email address
norouzi-na@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-22, 1405/03/01
Expected recruitment end date
2026-09-23, 1405/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of lavender and rose Essential oil on preoperative anxiety in children undergoing adenotonsillectomy surgery
Public title
The effect of aromatherapy with lavender and rose essential oils on preoperative anxiety in children undergoing adenotonsillectomy surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children who are candidates for tonsillectomy
No history of previous surgery or anesthesia
No history of allergic rhinitis
No history of respiratory or skin allergies in the child or mother
No chronic pain in the child
No long-term history of digestive problems
Accompanying a first-degree parent
Informed consent to participate in the study
Exclusion criteria:
Age
From 3 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, a member of the research team, acting as a nutritionist, will use four color labels, red, orange, yellow, and blue, to code each bottle containing the essential oil. Each bottle will then be placed inside a box, and each box will be labeled with the same color label according to the color of the bottle. Participants will be randomly assigned to the treatment or placebo group using balanced block randomization (https://www.sealedenvelope.com/trials/) and color-coded.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, healthcare personnel (physicians, operating room nurses) responsible for patient care, and data collectors who assess the outcome are kept blind to the type of essential oil used.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Pezeshk Blvd, Qotb–e Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2026-03-15, 1404/12/24
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1404.075
Health conditions studied
1
Description of health condition studied
Anxiety before surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score on the Modified-Yale preoperative anxiety scale (YPAS) questionnaire
Timepoint
Measuring anxiety after the start of the intervention and before entering the operating room
Method of measurement
Preoperative anxiety will be measured using the standardized Modified Yale Preoperative Anxiety Scale (m-YPAS) questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Aromatherapy group with lavender essential oil
Category
Prevention
2
Description
Second intervention group: Aromatherapy group with rose essential oil
Category
Prevention
3
Description
Third intervention group: Aromatherapy group with combined lavender and rose essential oil
Category
Prevention
4
Description
Control group: received placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Matini Hospital
Full name of responsible person
Nahid Norouzi
Street address
Kashan, Amir Kabir Street, Matini Hospital
City
Kashan
Province
Isfehan
Postal code
8719674591
Phone
+98 31 5534 2020
Email
matinihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Hamidi
Street address
Kashan - 5th km. of Qotb Ravandi Boulevard - Kashan University of Medical Sciences - Research Office
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9399
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Nahid Norouzi
Position
instructor
Latest degree
Master
Other areas of specialty/work
Operating room technology
Street address
Pezeshk Blvd, Qotb–e Ravandi Blvd, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 3142
Email
n.noroozi1992@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Nahid Norouzi
Position
instructor
Latest degree
Master
Other areas of specialty/work
Operating room technology
Street address
Pezeshk Blvd, Qotb–e Ravandi Blvd, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 3142
Email
n.noroozi1992@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Nahid Norouzi
Position
instructor
Latest degree
Master
Other areas of specialty/work
Operating room technology
Street address
Pezeshk Blvd, Qotb–e Ravandi Blvd, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 3142
Email
n.noroozi1992@yahoo.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
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
Access period starts 6 months after results are published.
To whom data/document is available
Our data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In order to conduct scientific research
From where data/document is obtainable
Please send a message to the following email address: n.noroozi1992@yahoo.com
What processes are involved for a request to access data/document
The required files will be sent immediately after receiving the applicant's message and providing documentation regarding the research work.