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Evaluation effect of aromatherapy with rose essential on nausea and vomiting in patients undergoing chemotherapy: A randomized control trial

Protocol summary

Study aim
Determining the effect of aromatherapy with rose essential on the severity of nausea and vomiting in patients undergoing chemotherapy.
Design
Clinical trial with control group, with parallel group, no blinding, Randomized, phase 3 on 66 patients, for randomization, Sealed Envelope Ltd's online randomization service will be used
Settings and conduct
This research will be carried out in Rasht's Beesat Clinic in the chemotherapy unit. The severity of nausea and vomiting is evaluated once three hours before chemotherapy, after that 5 minutes before the start of chemotherapy, 3 drops of rose essential with a concentration of 40% were poured on sterile gauze 5x5. It is connected to the patient's collar with a safety pin . This intervention is performed before each cycle of chemotherapy. Then the severity of nausea and vomiting is evaluated in three six-hour intervals. But in the control group, no intervention is used as a placebo because of the smell of roses.
Participants/Inclusion and exclusion criteria
Inclusion criteria : age over 18 years, ability to understand and speak persian, having the experience of at least one cycle of chemotherapy and prescribing chemotherapy drugs that are classified as severe in terms of nausea and vomiting. Non-entry criteria: allergy to herbal medicines and essential oils, suffering from brain malignancies and other metastases, presence of hepatitis and lack of sense of smell.
Intervention groups
In this study, the intervention group receives aromatherapy, routine care and routine nausea and vomiting medications. The severity of nausea and vomiting is evaluated before and after chemotherapy. The control group is a group that receives routine care and medication, but does not receive aromatherapy.
Main outcome variables
Nausea and vomiting severity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100921004787N7
Registration date: 2022-08-31, 1401/06/09
Registration timing: prospective

Last update: 2022-08-31, 1401/06/09
Update count: 0
Registration date
2022-08-31, 1401/06/09
Registrant information
Name
Tahereh Khaleghdoost Mohammadi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1555 5058
Email address
khaleghdoost@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effect of aromatherapy with rose essential on nausea and vomiting in patients undergoing chemotherapy: A randomized control trial
Public title
Effect rose essential on nausea and vomiting of chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Having the experience of at least one cycle of chemotherapy The ability to understand and speak Persian Prescribing chemotherapy drugs that are classified as severe in terms of nausea and vomiting.
Exclusion criteria:
The presence of hepatitis Suffering from brain malignancies and other metastases Allergy to herbal medicines and essential oils Lack of sense of smell
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible patients will be divided using the block randomization method with the size of 4 and 6 blocks equally (ratio 1:1) into aromatherapy groups with rose essence and control. Sealed Envelope Ltd.'s online randomization service will be used to generate the randomization list. Also used for concealment are sequentially numbered opaque sealed envelopes(SNOSE).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical sciences
Street address
Student of Nursing and Midwifery faculty, Shahid Beheshti Highway, Rasht
City
Rasht
Province
Guilan
Postal code
4146939841
Approval date
2022-07-13, 1401/04/22
Ethics committee reference number
IR.GUMS.REC.1401.220

Health conditions studied

1

Description of health condition studied
Nausea and vomiting severity after chemotherapy
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting

Primary outcomes

1

Description
Nausea and vomiting severity
Timepoint
Measuring the severity of nausea and vomiting once three hours before the intervention and then in three six-hour intervals after the intervention
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The group in which severity of nausea and vomiting are evaluated once in three hours before chemotherapy. Then, in the patient's room, five minutes before the start of chemotherapy, 3 drops of rose essential with a concentration of 40%, which is from an Iranian plant company(Lavender), is poured on sterile gauze 5*5, then the gauze is adjusted so that it is connected to the patient's collar by a pin at the closest distance (twenty centimeters) to the patient's nose. then the patient is asked to breathe normally for three minutes, and this is done every time before each cycle of chemotherapy. After the end of the chemotherapy session, the severity of nausea and vomiting of the client will be evaluated during three six-hour intervals using the Visual Analogue Scale tool. These patients will follow all the doctor's prescriptions and usual care such as taking anti-nausea drugs, corticosteroids, benzodiazepines and other drugs.
Category
Prevention

2

Description
Control group: A group in which no intervention is used as a placebo because of the smell of roses. So the severity of nausea and vomiting will be assessed once in a three-hour period before chemotherapy. Also, after the end of the chemotherapy session, the severity of nausea and vomiting of the patients will be examined during three six-hour intervals using the Visual Analogue Scale tool. These patients will follow all the doctor's prescriptions and usual care such as taking anti-nausea drugs, corticosteroids, benzodiazepines and other drugs.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Subspecialty Clinic Beesat
Full name of responsible person
Pouria Takasi
Street address
Subspecialty Clinic Beesat, Enghelab Street, Rasht
City
Rasht
Province
Guilan
Postal code
4136617865
Phone
+98 13 3326 1451
Email
razihospital@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohamad Reza Naghipoor
Street address
Namjoo Street Rasht
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 6394
Email
naghi@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Pouria Takasi
Position
Master Science Student of Medical Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Daneshjoo Street, Shahid Beheshti Highway, Rasht
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3326 2950
Email
Pooryapin380@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Tahereh Khaleghdoost Mohammadi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Daneshjoo Street, Shahid Beheshti Highway, Rasht
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3355 3202
Email
khaleghdoost@gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Tahereh khaleghdoost Mohammadi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Daneshjoo Street, Shahid Beheshti Highway, Rasht
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+098 13 33553202
Email
khaleghdoost@gums.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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All original data can be shared after de-identifying individuals.
When the data will become available and for how long
Beginning of access from 2023
To whom data/document is available
Researchers of universities of medical sciences
Under which criteria data/document could be used
Raw data is not made available to everyone. If using published results, reference should be made to the article. The requesting researcher is allowed to carry out this method in similar studies.
From where data/document is obtainable
Pouria Takasi; email: pooryapin380@gmail.com Tahereh Khaleghdoost Mohammdi; email: khaleghdoost@gums.ac.ir
What processes are involved for a request to access data/document
First, send your request via email. If approved, the requested information will be sent in one working week.
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