Determine the effect of inhalation of ginger extract with peppermint extract on postoperative nausea and vomiting of cholecystectomy
Design
Randomized clinical trial with parallel group design of 90 patients.
Settings and conduct
The aim of this study is determine the effect of inhalation of ginger extract with peppermint extract on postoperative nausea and vomiting of cholecystectomy at Besat hospital. Patients will be randomly divided into three groups.In the group of ginger and peppermint extract, the patients were intercepted with zipped bags containing 2 pads impregnated with 6 drops of ginger extract and peppermint extract, and in the placebo group, pads stained with 1 cc normal saline in zipper bags . Inhale the pads 3 times per minute through the nose and slowly exhale through the mouth. These interventions will continue for 5 minutes. Ten and 30 minutes after the intervention, the severity of nausea will be evaluated based on the VAS scale and 5-point likert scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having nausea before the intervention; age over 18 years old; not sensitive to essential oils.
Exclusion criteria: discharge before the end of the intervention; vomiting without nausea before or during the intervention.
Intervention groups
In the group of ginger and peppermint extract, the patients were intercepted with zipped bags containing 2 pads impregnated with 6 drops of ginger extract and peppermint extract, and in the placebo group, pads stained with 1 cc normal saline in zipper bags . Inhale the pads 3 times per minute through the nose and slowly exhale through the mouth. These interventions will continue for 5 minutes.
Main outcome variables
Nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170123032129N4
Registration date:2018-02-11, 1396/11/22
Registration timing:registered_while_recruiting
Last update:2018-02-11, 1396/11/22
Update count:0
Registration date
2018-02-11, 1396/11/22
Registrant information
Name
Azim Azizi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
a.azizi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-13, 1396/10/23
Expected recruitment end date
2019-01-13, 1397/10/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison effect of ginger and peppermint inhalation on nausea and vomiting after post-operative Cholecystectomy
Public title
Effect of ginger and peppermint inhalation on nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old
Having nausea before the intervention
Not sensitive to essential oils
Exclusion criteria:
Discharge before the end of the intervention
Vomiting without nausea before or during the intervention
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
With simple randomization method, patients are randomly assigned to one of the three groups of ginger extract, peppermint extract and placebo.
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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2018-01-13, 1396/10/23
Ethics committee reference number
IR.UMSHA.REC.1396.668
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
nausea and vomiting
Timepoint
10 and 30 minutes after intervention
Method of measurement
visual analogue scale to measure severity of nausea
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the group of ginger and peppermint extract, the patients were intercepted with zipped bags containing 2 pads impregnated with 6 drops of ginger extract and peppermint extract. Inhale the pads 3 times per minute through the nose and slowly exhale through the mouth. These interventions will continue for 5 minutes.
Category
Treatment - Other
2
Description
Control group: Pads stained with 1 cc normal saline in zipper bags and inhale the pads 3 times per minute through the nose and slowly exhale through the mouth. These interventions will continue for 5 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Azim Azizi
Street address
Shahid Fahmideh Street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
A.azizi@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh Street, Hamadan University of Medical Sciences, Hamadan
City
Hamdan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s.bashirian@umsha.ac.ir
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
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
Hamedan University of Medical Sciences
Full name of responsible person
Azim Azizi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
:38698-65178
Phone
+98 81 3838 0535
Email
A.azizi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azim Azizi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
:38698-65178
Phone
+98 21 8670 5503
Email
A.azizi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azim Azizi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
:38698-65178
Phone
+98 81 3838 0535
Email
A.azizi@umsha.ac.ir
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
There is no more information.
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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