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Comparison of the Effect of Aromatherapy with Orange and Peppermint Essential Oils on Nausea, Vomiting, and Anxiety in Children with Cancer Undergoing Chemotherapy Referred to Hospitals and Clinics Affiliated with Shiraz University of Medical Sciences

Protocol summary

Study aim
Determine the effect of aromatherapy with orange and peppermint essential oils on nausea, vomiting, and anxiety in children with cancer undergoing chemotherapy
Design
Randomized, parallel group, placebo-controlled, single-blind clinical trial on 120 patients will use permutation block method for allocation
Settings and conduct
Aromatherapy will be performed on patients in the pediatric chemotherapy wards of Amir Oncology Hospital and Imam Reza (AS) Specialized and Subspecialized Clinic affiliated with Shiraz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
120 patients undergoing chemotherapy. Main inclusion criteria: Age 9-12 years, definitive diagnosis of cancer, Ability to speak Persian, healthy sense of smell, no respiratory problems, no diseases causing vomiting, no history of psychological problems, no use of sedatives or anti-anxiety medications. Main exclusion criteria: Unwillingness of the child or parents to participate, allergy to plant essential oils.
Intervention groups
In the peppermint essential oil aromatherapy group, in addition to routine ward care, aromatherapy will be administered using two drops of peppermint essential oil placed on a gauze pad. This pad will be attached to the child's collar with a pin, 20 cm from the child's nose. The child will be asked to breathe normally for twenty minutes. In the aromatherapy group with orange essential oil, two drops of orange essential oil will be used for aromatherapy, and in the placebo group, two drops of liquid paraffin will be used to create the appearance of essential oil.
Main outcome variables
Nausea and Vomiting Anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260414069075N1
Registration date: 2026-05-05, 1405/02/15
Registration timing: prospective

Last update: 2026-05-05, 1405/02/15
Update count: 0
Registration date
2026-05-05, 1405/02/15
Registrant information
Name
Narges Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
nargesrahimi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-24, 1405/03/03
Expected recruitment end date
2026-07-27, 1405/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Aromatherapy with Orange and Peppermint Essential Oils on Nausea, Vomiting, and Anxiety in Children with Cancer Undergoing Chemotherapy Referred to Hospitals and Clinics Affiliated with Shiraz University of Medical Sciences
Public title
The Effect of Aromatherapy with Orange and Peppermint Scents on Reducing Nausea, Vomiting, and Anxiety in Children Undergoing Chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 9–12 years of both genders Ability to understand and speak Persian No history of hypersensitivity, allergic rhinitis, and asthma or known respiratory problems Having a healthy sense of smell Receiving chemotherapy with drugs that have moderate to severe emetogenic potential Not having diseases that lead to vomiting The patient’s ability to determine the severity of nausea, vomiting, and anxiety according to the protocol No history of psychological problems or anxiety disorders according to self-report No use of sedative or anxiolytic drugs A history of receiving at least one session of chemotherapy, and reporting nausea and vomiting after that
Exclusion criteria:
Lack of willingness of the child and parents to perform the intervention Sensitivity to herbal essential oils Use of other complementary medicine methods
Age
From 9 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization process will utilize permuted block randomization to assign the participants to the three study groups. A total of 120 participants will be allocated using 20 blocks of size six.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst will be blinded to the allocation of groups to active intervention or placebo groups to prevent potential bias in interpretation the results. The allocation of groups will be disclosed to the analyst once the analysis is fully completed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Nursing and Midwifery school, Namazi square, Shiraz
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2026-01-31, 1404/11/11
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1404.140

Health conditions studied

1

Description of health condition studied
Nausea and Vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting

2

Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
Nausea score on the Adapted Rhodes Index of Nausea and Vomiting for Pediatric
Timepoint
Before intervention, 12 and 24 hours after chemotherapy
Method of measurement
Adapted Rhodes Index of Nausea and Vomiting for Pediatric

2

Description
Vomiting score on the Adapted Rhodes Index of Nausea and Vomiting for Pediatric
Timepoint
Before intervention, 12 and 24 hours after chemotherapy
Method of measurement
Adapted Rhodes Index of Nausea and Vomiting for Pediatric

3

Description
Anxiety score on the Spielberger's State-Trait Anxiety Inventory for Children
Timepoint
Before intervention, 12 and 24 hours after chemotherapy
Method of measurement
Spielberger's State-Trait Anxiety Inventory for Children

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the orange essential oil aromatherapy group, in addition to routine ward care, aromatherapy will be administered using two drops of orange essential oil placed on a 2x2 cm gauze pad. This pad will be attached to the child's collar with a pin, 20 cm from the child's nose. The child will be asked to breathe normally for twenty minutes.
Category
Rehabilitation

2

Description
Intervention group: In the peppermint essential oil aromatherapy group, in addition to routine ward care, aromatherapy will be administered using two drops of peppermint essential oil placed on a 2x2 cm gauze pad. This pad will be attached to the child's collar with a pin, 20 cm from the child's nose. The child will be asked to breathe normally for twenty minutes.
Category
Rehabilitation

3

Description
Control group: In the placebo group, in addition to routine ward care, aromatherapy will be simulated using two drops of liquid paraffin placed on a 2x2 cm gauze pad. This pad will be attached to the child's collar with a pin, 20 cm from the child's nose. The child will be asked to breathe normally for twenty minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Oncology Hospital
Full name of responsible person
Narges Rahimi
Street address
Amiral Oncology Hospital, Station 11, Farhang Shahr, Shiraz
City
Shiraz
Province
Fars
Postal code
7187915998
Phone
+98 71 3632 3532
Email
amirhp@sums.ac.ir
Web page address
https://amirhosp.sums.ac.ir

2

Recruitment center
Name of recruitment center
Imam Reza (AS) Specialized and Subspecialized Clinic
Full name of responsible person
Narges Rahimi
Street address
Imam Reza (AS) Specialized and Subspecialized Clinic, next to Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Email
emamreza@sums.ac.ir
Web page address
https://emamreza.sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Web page address
https://sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Narges Rahimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and midwifery school, Namazi square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
nargesrahimi.hr@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Neda Jamali Moghadam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery school, Namazi square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
nedajamali21@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Narges Rahimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery school, Namazi square, Shiraz.
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
nargesrahimi.hr@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
Data can be shared after de-identifying individuals.
When the data will become available and for how long
Six months after publication of the article
To whom data/document is available
Research team
Under which criteria data/document could be used
For the use of patients undergoing chemotherapy and to expand knowledge
From where data/document is obtainable
Research team
What processes are involved for a request to access data/document
Written request
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