Determining the comparison of nausea of patients undergoing chemotherapy in the scent group of Ishtakhdos and the group of Mohammadi flowers.
Design
A controlled, symmetrical, single-blind, randomized, phase 3 clinical trial of 120 patients. A sealed envelope is used for randomization.
Settings and conduct
The study aims to reduce nausea in patients undergoing chemotherapy in Shahid Beheshti Hospital.
Three drops of the relevant essential oil (2 drops of rose and 1 drop of lavender in the combined group) and distilled water in the placebo group are poured on a napkin and placed at a distance of 10-15 cm from the nose on the first night of chemotherapy by taking 5 deep breaths and He inhales from 10 pm to 6 am.
Participants/Inclusion and exclusion criteria
Not using aromatherapy in the last month and complementary medicine during the intervention
No allergic rhinitis, asthma, chronic lung disease, and no allergy to medicinal herbs
Symptoms of sensitivity to the used fragrance
Intervention groups
The intervention groups include: the lavender group, rose flower group, a combination of lavender and rose flower (3 drops of rose flower and 2 drops of lavender), and placebo group (distilled water). The patients in each group are asked to inhale the desired substance for three consecutive nights when they have received chemotherapy, pour it on a napkin and place it at a distance of 8 cm from the nose and inhale it from 10:00 PM to 6:00 AM.
Main outcome variables
Reduce nausea
General information
Reason for update
Acronym
LRH
IRCT registration information
IRCT registration number:IRCT20220528055008N1
Registration date:2022-07-17, 1401/04/26
Registration timing:registered_while_recruiting
Last update:2022-07-17, 1401/04/26
Update count:0
Registration date
2022-07-17, 1401/04/26
Registrant information
Name
Zahra Kordvarkaneh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3274 7386
Email address
zahrakordvarkane955@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-10, 1401/04/19
Expected recruitment end date
2022-10-11, 1401/07/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparion of aromatherapy with essential oils of Lavender and Rose on nausea and vomiting in patients undergoing chemotherapy
Public title
The effect of lavender and rosemary essential oil on nausea and vomiting in chemotherapy patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Do not use aromatherapy in the past month
No allergic rhinitis, asthma, chronic lung disease, sleep disorders, and other chronic diseases that affect the sense of smell
No history of allergy to medicinal plants
Have a course of at least 3 days of chemotherapy.
Exclusion criteria:
Occurrence of a stressful event: death of relatives, divorce, etc. during the study
Using other complementary medicine interventions while studying
Symptoms of sensitivity to the used fragrance
Having pain while studying
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be available and then random allocation will be done, and every day each of the research samples that meet the criteria for entering the study will randomly select an envelope from among the sealed envelopes. In this way, the group Rosemary, Stochodos, placebo, and mixed (rosemary and Stochodos in a ratio of 3 to 2) are assigned to complete the sample size in each group and all 4 groups.
The method of blinding is in the form of a blind. Only the patients did not know which group they were in. Patients receiving the scent are hospitalized in separate rooms.
Blinding (investigator's opinion)
Single blinded
Blinding description
Glasses of essential oils and distilled water have the same shape, size, and color.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Hamadan University of Medical Sciences
Street address
No. 47,Tima One Alley, Al-Ghadir Boulevard, Imam Hossein Square, Hamedan.
City
Hamadan
Province
Hamadan
Postal code
6513745373
Approval date
2022-05-06, 1401/02/16
Ethics committee reference number
IR.UMSHA.REC.1401.147
Health conditions studied
1
Description of health condition studied
Nausea of chemotherapy patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nausea score on visual analog scale is less than 5.
Timepoint
Measurement of nausea at the beginning of the intervention (before the intervention) and 1, 2, 3 and the day after inhalation of lavender, rose and placebo essential oils
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Lavender essential oil group, chemical compounds linalyl acetate 25-47, linalool 20-45, cineol maximum 2.5%, limonene maximum 1%, camphor maximum 1.2%, alpha-terpineol maximum 2%, baric essential oil company, 3 drops of essential oil Shed 10-15 cm from the nose is inhaled from 22 to 6 in the morning for 8 hours.
Category
Rehabilitation
2
Description
Rose essential oil group, 100% distilled rose essential oil compositions, and 3 drops of rose essential oil from Barich Essential Oil Company are poured on a napkin and placed at a distance of 10-15 cm from the nose from 22:00 to 6:00 in the morning and inhaled for 8 hours. Be.
Category
Rehabilitation
3
Description
Intervention group: Combined group of ostrich essential oil and rose, 2 drops of ostrich essential oil of Barich Essential Oil Company, including linalyl acetate 25-47, linalool 20-45, cineol maximum 2.5%, limonene maximum 1%, camphor maximum 1.2%, alpha-terpineol maximum 2% and 3 rose essential oils Baric Company puts 100% rose essential oil on a napkin at a distance of10-15 cm from the nose and is inhaled from 22:00 to 6:00 in the morning.
Category
Rehabilitation
4
Description
Control group: Placebo group: 3 drops of distilled water is placed on a napkin at a distance of 10-15 cm from the nose and is inhaled from 8 pm to 6 am for 8 hours.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Zahra Kordvarkaneh
Street address
No. 47,Tima One Alley, Al-Ghadir Boulevard, Imam Hossein Square, Hamedan.
City
Hamadan
Province
Hamadan
Postal code
6513745373
Phone
+98 81 3274 7386
Email
zahrakordvarkane955@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shirin Sharifi
Street address
No. 47,Tima One Alley, Al-Ghadir Boulevard, Imam Hossein Square, Hamedan.
City
Hamadan
Province
Hamadan
Postal code
6513745373
Phone
+98 81 3274 7386
Email
zahrakordvarkane955@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
80
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
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Kordvarkaneh
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 47,Tima One Alley, Al-Ghadir Boulevard, Imam Hossein Square, Hamedan.
City
Hamadan
Province
Hamadan
Postal code
6513745373
Phone
+98 81 3274 7386
Email
zahrakordvarkane955@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Kordvarkaneh
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 47,Tima One Alley, Al-Ghadir Boulevard, Imam Hossein Square, Hamedan.
City
Hamadan
Province
Hamadan
Postal code
6513745373
Phone
+98 81 3274 7386
Email
zahrakordvarkane955@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Kordvarkaneh
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 47,Tima One Alley, Al-Ghadir Boulevard, Imam Hossein Square, Hamedan.
City
Hamadan
Province
Hamadan
Postal code
6513745373
Phone
+98 81 3274 7386
Email
zahrakordvarkane955@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
Undecided - It is not yet known if there will be 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
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
All potential data can be shared after unidentified individuals. Includes: study results, severity of nausea of drugs, age of people, types of cancer and nausea of related drugs
When the data will become available and for how long
6 months after printing
To whom data/document is available
All researchers and patients
Under which criteria data/document could be used
It can be used if the results are generalized to the type of drug, not the type of cancer and its association with nausea.
From where data/document is obtainable
By e-mail address
What processes are involved for a request to access data/document
After sending an email from the applicant, the file will be provided to the person 1 month later.