Comparison the effects of aromatherapy with peppermint oil and routine drug for chemotherapy induced nausea and vomiting in patients with breast cancer
The objective of this study is to determine the effect of Aromatherapy with peppermint oil on chemotherapy- induced nausea and vomiting in patients with Breast cancer. This study is a Randomized clinical trial. The study population included 100 women who referred to Rasoul Akram hospital and Cancer Institute of Iran. Inclusion criteria: patients Aged 18-65 years, who Receiving cisplatin and anthracycline for the first cycle of chemotherapy. Patients who are reluctant to complete the study or have allergy to peppermint oil will be excluded. After obtaining inform consent, convenience sampling method will be used to recruit the study subjects, then participants will randomly allocated to the intervention group and the control group. The intervention group, besides the standard medications prescribed by a doctor, will trained to pour 2 drops pure peppermint oil (Barij Essence Kashan) by dropper on a napkin (size 20 × 20 cm) and attach with a pin on their collar then will be asked for taking breathe normally for 20 minutes. They will teach to do it three times each day (morning, noon and evening) for five consecutive days. For control group will be used normal saline as a placebo. To assess the nausea and vomiting, Rhodes questionnaire will be completed for the subsequent 5 days by both the intervention and the control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050215649N2
Registration date:2014-11-14, 1393/08/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-14, 1393/08/23
Registrant information
Name
Mohammad Eghbali
Name of organization / entity
Torbat Heydariyeh University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5242 1257
Email address
m-eghbali@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Nursing and Midwifery, Tehran University of Medical Sciences
Expected recruitment start date
2014-11-01, 1393/08/10
Expected recruitment end date
2015-04-30, 1394/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of aromatherapy with peppermint oil and routine drug for chemotherapy induced nausea and vomiting in patients with breast cancer
Public title
The effects of aromatherapy with peppermint oil for chemotherapy induced nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients Aged 18-65 years, who Receiving cisplatin and anthracycline for the first cycle of chemotherapy, Healthy sense of smell.
Exclusion criteria: reluctant to complete the study or have allergy to peppermint oil.
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
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 Tehran University of Medical Science
Street address
Sixth Floor, Central Organization of University, Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2014-05-18, 1393/02/28
Ethics committee reference number
93/02/28/25630
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Acute and delayed nausea
Timepoint
Data are gathered for five days after starting chemotherapy
Method of measurement
Rhodes Questionnaire
Secondary outcomes
1
Description
Acute and delayed vomiting
Timepoint
Data are gathered for five days after starting chemotherapy
Method of measurement
Rhodes Questionnaire
Intervention groups
1
Description
The intervention group, besides the standard medications prescribed by a doctor, will trained to pour 2 drops pure peppermint oil (Barij Essence Kashan) by dropper on a napkin (size 20 × 20 cm) and attach with a pin on their collar then will be asked for taking breathe normally for 20 minutes. They will teach to do it three times each day (morning, noon and evening) for five consecutive days
Category
Prevention
2
Description
For control group will be used normal saline as a placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul akram hospital
Full name of responsible person
Mohammad Eghbali
Street address
Niayesh St, sattarkhan St.
City
Tehran
2
Recruitment center
Name of recruitment center
Cancer Institute of Imam Khomeini Hospital in Tehran
Full name of responsible person
Mohammad Eghbali
Street address
Cancer Institute Central 2, Dr. Gharib St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Doctor Masood Younesian - Vice President of Research and Technology
Street address
Keshavarz St, Qods St., Central Building, Sixth Floor, Tehran University of Medical Sciences, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Eghbali
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery Tehran University of Medical Sciences, Dr Mirkhani St, Tohid Sq Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
eghbali.msn@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Doctor Shokouh Varaei
Position
PhD in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery Tehran University of Medical Sciences, Dr Mirkhani St, Tohid Sq Tehran
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
Shvaraei@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Eghbali
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery Tehran University of Medical Sciences, Dr Mirkhani St, Tohid Sq, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)