Protocol summary

Summary
The aim of this study is to determine the effects of Cardamom aromatherapy on the nausea and vomiting induced by chemotherapy in cancerous patients. The design is a categorized-blocked randomized clinical trial conducted through the single-blinded randomized with a placebo control group. The categorized-blocked allocation method will be based on the type of chemotherapy medication and gender. 58 cancer patients undergoing chemotherapy in the Shaheed Beheshti Hospital and of Imam Khomeini Clinic in Hamadan will be participated. Inclusion criteria are: having aged 65-18 years and nausea in the acute phase of chemotherapy no history of asthma and vegetable essence oils allergies. Exclusion criteria include: having vomiting without nausea before performing the intervention. The patients will be randomly assigned to the experimental group or the control group after expressing their nausea and signing the informed consent. The patients’ nausea is determined by VAS at the entrance to the study. Then, the patients in the experimental group will receive three deep breaths with the essential oil of cardamom soaked pads and the patients in the control group will receive three deep breaths with the placebo (distilled water) soaked pads. 5 minutes later, the nausea of the patients in the both groups are measured by VAS. If nausea remains, the intervention will be repeated and again after 5 minutes the nausea is measured according to VAS. The frequency of their retching and vomiting in the acute phase of chemotherapy are assessed after the implementation of research protocols in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013071013936N1
Registration date: 2013-12-06, 1392/09/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-12-06, 1392/09/15
Registrant information
Name
Zahra Khalili
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1828 0332
Email address
z.khalili@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Hamadan University of Medical Sciences
Expected recruitment start date
2013-12-06, 1392/09/15
Expected recruitment end date
2014-05-05, 1393/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cardamom aromatherapy on nausea and vomiting induced by chemotherapy in cancerous patients
Public title
The effects of the Cardamom aroma on the nausea and vomiting induced by chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-65 years old; having a healthy olfactory; no history of asthma; no allergies to herbal essences; no history of chronic obstructive pulmonary disease; absence nausea due to the other reason verified by the physician; expression nausea after starting chemotherapy in the acute phase. Exclusion criterion: vomiting without nausea before the intervention protocol.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
None
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 the Hamadan University of Medical Sciences
Street address
Fahmideh St., University of Medical Sciences, Hamedan
City
Hamaden
Postal code
8698365178
Approval date
2013-09-09, 1392/06/18
Ethics committee reference number
1683/9/35/16/پ

Health conditions studied

1

Description of health condition studied
Malignant neoplasm
ICD-10 code
C00-97
ICD-10 code description
Malignant neoplasms

Primary outcomes

1

Description
The severity of nausea induced by chemotherapy
Timepoint
Before the experiment, 5 minutes after the first intervention, and 5 minutes after second intervention
Method of measurement
Visual Analog Scale (VAS)

Secondary outcomes

1

Description
Number of vomiting
Timepoint
In the acute phase after research protocol intervention
Method of measurement
Frequency and/or multiple-choice questionnaire

2

Description
Number of retching
Timepoint
In the acute phase of chemotherapy after protocol implementation
Method of measurement
Frequency and/or multiple-choice questionnaire

Intervention groups

1

Description
The patients in the control group will receive the placebo. In order to prepare the placebo, two 2" × 2" gas pads will be soaked with 2 ml of distilled water put in a zipper plastic bag. The patients asked to inhale three deep breaths of placebo after rating her/him nausea severity according to VAS. 5 minutes later, the nausea of the patients is measured by VAS. Then, if nausea remains, the intervention will be repeated and again after 5 minutes the nausea is measured according to VAS. The frequencies of their retching and vomiting in the acute phase of chemotherapy are assessed after the implementation of research protocol.
Category
Placebo

2

Description
The patients in the experimental group will receive the essential oil of cardamom. In order to prepare the essential oil of cardamom, two 2" × 2" gas pads will be soaked with 2 drops of essential oil of cardamom and 2 ml of distilled water put in a zipper plastic bag. The patients asked to inhale three deep breaths of the cardamom essential oil pads after rating her/him nausea severity according to VAS. 5 minutes later, the nausea of the patients is measured by VAS. Then, if nausea remains, the intervention will be repeated and again after 5 minutes the nausea is measured according to VAS. The frequencies of their retching and vomiting in the acute phase of chemotherapy are assessed after the implementation of research protocol.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Educational and Medical Center
Full name of responsible person
Zahra Khalili
Street address
Hamedan, Eram Blv. Beheshti Educational and Medical Center
City
Hamadan

2

Recruitment center
Name of recruitment center
Clinic of Imam Khomeini
Full name of responsible person
Zahra Khalili
Street address
Hamadan, Mirzadeheshghi St. Clinic of Imam Khomeini
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University of Medical Sciences, Vice chancellor for Research.
Full name of responsible person
Dr. Saeed Bashirian
Street address
Fahmideh St., University of Medical Sciences, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences, Vice chancellor for Research.
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
Hamadan, University of Medical Sciences
Full name of responsible person
Zahra Khalili
Position
Critical Care Nursing Graduate Student
Other areas of specialty/work
Street address
Fahmideh St., Hamadan University of Medical Sciences
City
Hamadan
Postal code
8698365178
Phone
+98 81 1838 0319
Fax
+98 81 1838 0447
Email
z.khalili@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mother and Child Care Research Center, Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Khatiban
Position
Ph.D. in Nursing
Other areas of specialty/work
Street address
Fahmideh St., Hamadan University of Medical Sciences
City
Hamadan
Postal code
8698365178
Phone
+98 81 1838 0150
Fax
+98 81 1838 0447
Email
m-khatiban@umsha.ac.ir; mahnaz.khatiban@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Zahra Khalili
Position
Critical Care Nursing Graduate Student
Other areas of specialty/work
Street address
Fahmideh St., Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 81 1838 0319
Fax
+98 81 1838 0447
Email
z.khalili@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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