In this randomized clinical study,single blind for experimental groups, 120 eligible patient will randomly be allocated between the intervention and the control group. After surgical procedure, When patients are transferred to the recovery room, in the intervention group 2 drops of ginger essence will be dripped on A2*2 gaze and this will be repeated every 15 minute during 2 hours of patients stay in recovery room. Nausea and vomiting will be checked every 15 minute for 2hours and then after 6 hours when the patients are transferred to ward. In the control group the same procedure will be done but 2 drops of normal saline will be used instead of ginger. Nausea will be assessed using a Visual analog scale.
General information
Acronym
Effect of ginger essence on PONV
IRCT registration information
IRCT registration number:IRCT2014080218650N1
Registration date:2014-09-07, 1393/06/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-07, 1393/06/16
Registrant information
Name
Fatemeh Sadat Hosaini
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2632 1942
Email address
fatemehhosaini57@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Kashan University of Medical Sciences
Expected recruitment start date
2014-09-01, 1393/06/10
Expected recruitment end date
2015-01-02, 1393/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of inhalation of ginger essence on nausea and vomiting after nephrectomy
Public title
Effect of inhalation of ginger essence on nausea and vomiting after nephrectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age of 18 years or older; any known allergy to ginger; not having motion sickness (car-sea); not receiving anti-emetic drugs; not receiving warfarin, heparin, aspirin 325 mg;no receiving chemotherapy drugs; being NPO for at least 8 hours before surgery, not having a history of asthma and other respiratory disorder; not having an olfactory sensation disorders, ability to read and write; not having disorders of brain stem and cerebellum, not having a coagulopathy.
Exclusion criteria: occurring any allergic reaction to ginger during the study; intolerance to ginger essence odor.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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 Kashan University of Medical Sciences"
Street address
Ghotbe ravandi road, km 5.
City
Kashan
Postal code
8715981151
Approval date
2014-07-22, 1393/04/31
Ethics committee reference number
29/5/1/1899/p
Health conditions studied
1
Description of health condition studied
Nausea and Vomiting
ICD-10 code
R11
ICD-10 code description
Other diseases of the digestive system
2
Description of health condition studied
kidney surgery
ICD-10 code
XIV
ICD-10 code description
Other disorders of kidney
Primary outcomes
1
Description
Nausea
Timepoint
Every 15 minute during surgery and 2 hours and 6 hours after surgery.
Method of measurement
Visual Analog Scale
2
Description
Vomiting
Timepoint
number in the first 2 hours after the nefrectomy and after 6 hours
Method of measurement
Counting the number of vomiting
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: 2 drops of 100% ginger essence will be used on a piece of gauze that will be attached to the collar of the patients clothes every 15 minute for 2 hour in the recovery room.
Category
Treatment - Drugs
2
Description
control:normal saline,2 drop normal saline 9% every 15 minute for 2 hour to recovery room
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Labafenezhad Hospital
Full name of responsible person
Fatemeh Sadat hosaini
Street address
Valley 9, Pasdaran street, Tehran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Hamidi
Street address
Ghotb ravandi bolvard, Kashan
City
Kashan
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 of Kashan 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
"Kashan University of Medical Sciences"
Full name of responsible person
Fatemeh Sadat Hosaini
Position
Bachelor Of Science
Other areas of specialty/work
Street address
Ghotb ravandi bolvard, Kashan
City
Kashan
Postal code
8715981151
Phone
+98 315550021
Fax
+98 315556633
Email
fatemehhosaini57@kaums.ac.ir
Web page address
http://nursing.kaums.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
"Kashan University of Medical Sciences"
Full name of responsible person
Dr. Mohsen Adib-Hajbaghery
Position
Professor, faculty member
Other areas of specialty/work
Street address
Ghotb ravandi bolvard, Kashan
City
Kashan
Postal code
8715981151
Phone
+98 315550021
Fax
+98 315556633
Email
adib1344@yahoo.com
Web page address
http://nursing.kaums.ir
Person responsible for updating data
Contact
Name of organization / entity
"Kashan University of Medical Sciences"
Full name of responsible person
Fatemeh Sadat Hosaini
Position
Bachelor Of Science
Other areas of specialty/work
Street address
Ghotb ravandi bolvard, Kashan
City
Kashan
Postal code
8715981151
Phone
+98 315550021
Fax
+98 315556633
Email
fatemehhosaini57@kaums.ac.ir
Web page address
http://nursing.kaums.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)