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The survey of the effect of aromatherapy with Rosa damascena essence on chemotherapy-induced nausea and vomiting: a randomized clinical trial

Protocol summary

Study aim
Determining the effect of aromatherapy with Rosa damascena essence on chemotherapy-induced nausea and vomiting
Design
Phase 3 randomized clinical trial on 62 patients
Settings and conduct
This study will be conducted on cancer patients undergoing chemotherapy in the oncology department of Shahid Jalil Hospital in Yasuj city. In the intervention group, a cotton ball soaked in five drops of rose essential oil will be placed 30 centimeters away from the patient's nose. Patients will be instructed to breathe naturally for 20 minutes twice a day, and this process will be continued for three consecutive days
Participants/Inclusion and exclusion criteria
Confirmation of cancer diagnosis by an oncologist. Completion of at least one cycle of chemotherapy, despite the use of chemotherapy-induced antiemetic drugs, including cyclophosphamide, cisplatin, carboplatin, and doxorubicin, either as single-agent or multi-agent chemotherapy. No history of nausea and vomiting due to reasons other than chemotherapy. Absence of gastrointestinal issues and diarrhea. Age above 18 years. Non-pregnant and not breastfeeding. No use of sedative or antidepressant medications.
Intervention groups
In this study, participants will be selected through a convenient sampling method and will be randomly assigned to either the intervention or control group. In the intervention group, aromatherapy with rose essential oil will be combined with routine treatments, while the control group will receive the standard treatments (Granisetron, Dexamethasone, and Aprepitant).
Main outcome variables
Chemotherapy-induced nausea and vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121208011692N4
Registration date: 2025-02-18, 1403/11/30
Registration timing: prospective

Last update: 2025-02-18, 1403/11/30
Update count: 0
Registration date
2025-02-18, 1403/11/30
Registrant information
Name
Ardeshir Afrasiabifar
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 2223 4115
Email address
afrasiabifar.ardashir@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2025-05-21, 1404/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of the effect of aromatherapy with Rosa damascena essence on chemotherapy-induced nausea and vomiting: a randomized clinical trial
Public title
The survey of the effect of aromatherapy on patients undergoing chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of cancer by an oncologist Completed at least one course of chemotherapy with antiemetic chemotherapy drugs including cyclophosphamide, cisplatin, carboplatin and doxorubicin in a single or multiple regimen No history of nausea and vomiting for reasons other than chemotherapy No digestive problems or diarrhea Age over 18 Not pregnant or breastfeeding Not taking sedatives and antidepressants
Exclusion criteria:
Lack of study inclusion criteria Unwillingness to participate in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Participants eligible for the study will be selected using convenience sampling and will be randomly assigned to one of two intervention or control groups through block random assignment. First, we calculate the number of samples in each block by multiplying the number of study groups (two groups) by 2, resulting in a block size of 4. Next, we determine the total number of arrangements of individuals using a factorial calculation (1×2×3×4=4!=24), which indicates there will be 24 different blocks. Each block will contain 4 participants (2 from each group), arranged differently. The blocks will be randomly selected for placement, meaning that when a block is chosen, it will contain those 4 participants. The allocation method is clearly defined. The potential arrangements of participants within the blocks are as follows: ABCD, ABDC, ACBD, ACDB, ADBC, ADCB, BACD, BADC, BCAD, BCDA, BDAC, BDCA, CABD, CADB, CBAD, CBDA, CDAB, CDBA, DABC, DACB, DBAC, DBCA, DCAB, and DCBA. The group labels will be randomly assigned and drawn, with A representing the intervention group, while B and C designate the control group, and D also represents the intervention group. Each participant will be given a code, which corresponds with the block random allocation list, enabling them to be assigned to either the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Participants eligible for the study will be selected through convenience sampling and will be randomly assigned to one of the two intervention and control groups through block random assignment. The total number of samples is 62, with 31 in each group.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591615486
Approval date
2025-01-29, 1403/11/10
Ethics committee reference number
IR.YUMS.REC.1403.121

Health conditions studied

1

Description of health condition studied
Cancer
ICD-10 code
R97.1
ICD-10 code description
Elevated cancer antigen 125 [CA 125]

Primary outcomes

1

Description
Chemotherapy-induced nausea and vomiting score on the MAT questionnaire
Timepoint
In 3 cycles of chemotherapy, 2 times per cycle (in the first 24 hours and after the first 24 hours after chemotherapy)
Method of measurement
Multinational Association of Supportive Care in Cancer Antiemesis Tool

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, aromatherapy with Rosa damascena essence will be performed alongside routine treatments. The intervention will be carried out from the day of chemotherapy until the third day after chemotherapy and will continue for 3 consecutive cycles. To ensure that the participants are not allergic to the essential oil, a skin test will be performed on all patients in the intervention group. In this test, a drop of Rosa damascena essence with a concentration of 40% will be placed on the back of the patient's hand. After two minutes of contact with the skin, the back of the patient's hand will be examined for any allergic reaction (such as redness, hives, itching, etc.). Only those who do not have any allergy symptoms will be included in the study. In the next step, a cotton ball soaked in five drops of Rosa damascena essence will be placed 30 centimeters from the patient's nose. Patients are advised to breathe normally twice a day, for 20 minutes each time, and continue this process for three consecutive days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Jalil Hospital, Yasuj
Full name of responsible person
Afrasiabirar Ardashir
Street address
Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591615486
Phone
+98 917 341 1267
Email
afrasiabifar.ardashir@yums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hosseini Motlagh
Street address
Motahari Blvd, Research and Technology Department, Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
aminhomo@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Afrasiabifar Ardashir
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591615486
Phone
+98 74 3323 4115
Email
afrasiabifar.ardashir@yums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Afrasiabifar Ardashir
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591615486
Phone
+98 74 3323 4115
Email
afrasiabifar.ardashir@yums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Afrasiabifar Ardashir
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591615486
Phone
+98 74 3323 4115
Email
afrasiabifar.ardashir@yums.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
Yes - There is 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
Access period starts 6 months after results are published.
To whom data/document is available
For scientific researchers
Under which criteria data/document could be used
...
From where data/document is obtainable
09173411267 afrasiabifar.ardashir@yums.ac.ir
What processes are involved for a request to access data/document
By email and phone call
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