Determining the effect of sour lemon scent on vomiting nausea and anxiety of patients undergoing chemotherapy
Design
In this randomized clinical trial, patients will be randomly assigned to two groups of 25 people.
Settings and conduct
Aromatherapy during chemotherapy will be performed for 4 weeks in the chemotherapy department of Shahid Beheshti Hospital in Kashan.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age over 18 years؛Patients with breast and esophageal, gastric and intestinal cancers؛Healthy sense of smell؛No history of asthma or chronic obstructive pulmonary disease؛ Lack of sensitivity to plant essential oils؛Have a nausea score of at least 2؛Do not take sedatives or other medications to reduce anxiety for six weeks before the procedure؛Not addicted to drugs؛Chemotherapy once a week؛Patients with stage I, II cancer؛The goal of chemotherapy is therapy؛Exclusion criteria:Vomiting due to other diseases diagnosed by an oncologist؛The patient's inability to determine the severity of nausea despite the instructions؛Use complementary medicine methods to relieve anxiety or nausea and vomiting
Intervention groups
In the intervention group, its lemon scent will be used for 4 weeks during chemotherapy. In the control group, placebo will be used for 4 weeks.
Main outcome variables
Nausea and vomiting and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111210008348N45
Registration date:2020-07-06, 1399/04/16
Registration timing:registered_while_recruiting
Last update:2020-07-06, 1399/04/16
Update count:0
Registration date
2020-07-06, 1399/04/16
Registrant information
Name
Neda Mirbagher
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
mirbagher_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-06, 1399/03/17
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with lemon essential oils on nausea, vomiting and anxiety in patients undergoing chemotherapy
Public title
The effect of aromatherapy with lemon essential oils on nausea, vomiting and anxiety in patients undergoing chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years
Patients with breast and esophageal, gastric and intestinal cancers (due to the same drugs used)
Healthy sense of smell: Measurement by smelling alcohol
No history of asthma or chronic obstructive pulmonary disease
Lack of sensitivity to plant essential oils
Having a minimum nausea score of 2 based on vas criteria on the first day of study
No more anxiety score of 63
Do not take sedatives or other medications (such as using herbal essential oils, regular exercise) to reduce anxiety for six weeks before the intervention
Not addicted to drugs
Perform chemotherapy once a week
Patients with stage I, II cancer
The goal of chemotherapy is therapy
Exclusion criteria:
Use of other Complementary therapies
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation in two groups of intervention and control will be simple randomization. Randomization is carried out by creating a random sequence of numbers using on an line randomizer tool (https://www.randomizer.org).
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
Ethics committee of Kashan University of Medical Sciences
Street address
Ravand Street, Kashan University of Medical Sciences.
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2020-06-06, 1399/03/17
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1399.019
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, vomiting
Timepoint
Before and during the intervention
Method of measurement
Visual criteria for nausea and vomiting
Secondary outcomes
1
Description
Aََnxiety
Timepoint
Before and during the study
Method of measurement
Spielberger's Anxiety Questionnaire
Intervention groups
1
Description
In addition to the usual care of the ward (Geranisetron and Dexamethasone), the researchist pours a drop of sour lemon essential oil onto a paper towel with a drip during chemotherapy and attaches it to the collar of the research unit with a pin, then asks him to breathe normally. This method will be used once a week (during chemotherapy) for 4 weeks. The intervention of 5 minutes before the start of chemotherapy until receiving chemotherapy treatment for patients will be done. Aromatherapy with lemon essential oil is performed when the patient is lying on the bed and the paravan is lying around his bed.
Category
Treatment - Other
2
Description
Control group: In addition to the usual care of the ward (Geranisetron and Dexamethasone), the researchist pours 3 ml of water (placebo) poured on the paper and the collar is connected sick during chemotherapy.This method will be used once a week (during chemotherapy) for 4 weeks. The intervention of 5 minutes before the start of chemotherapy until receiving chemotherapy treatment for patients will be done. Aromatherapy with lemon essential oil is performed when the patient is lying on the bed and the paravan is lying around his bed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Chemotherapy, Shahid Beheshti Hospital, Kashan
Full name of responsible person
Morteza Moghari
Street address
Ravand street,Shahid Beheshti Hospital
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 31 5554 6633
Email
mortezamoghari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafsheh
Street address
Ravand Street, Kashan University Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 31 5554 6633
Email
mortezamoghari@gmail.com
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
Morteza Moghari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
15 Khordad Blvd., Alley 54, Alley 12, No. 8
City
Qom
Province
Ghoum
Postal code
3714834141
Phone
+98 25 3722 3661
Email
mortezamoghari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Moghari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
15 Khordad Blvd., Alley 54, Alley 12, No. 8
City
Qom
Province
Ghoum
Postal code
3714834141
Phone
+98 25 3722 3661
Email
mortezamoghari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Moghari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
15 Khordad Blvd., Alley 54, Alley 12, No. 8
City
Qom
Province
Ghoum
Postal code
3714834141
Phone
+98 25 3722 3661
Email
mortezamoghari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Data of participants are confidential
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available