Comparison the effect of sucking ice containing peppermint extract with cardamom extract on prevention of nausea and vomiting after laparoscopic cholecystectomy in patients hospitalized to general surgery wards in Hamadan Besat hospital -2019. General surgery section of Besat Hospital in Hamedan at 2019 conducted a comparison study between sucking mint & cardamom flavored ice to avoid nausea & vomiting after laparoscopic cholecystectomy operation.
Comparison the effect of sucking ice containing peppermint extract with cardamom extract on prevention of nausea and vomiting after laparoscopic cholecystectomy in patients hospitalized to general surgery wards
Design
Randomized clinical trial with parallel groups, 90 patients.
Settings and conduct
The place of the study is the general surgery wards in Hamadan Besat hospital. In the ice group containing peppermint extract, 6 drops of peppermint extract 10%, mixed with 1 cc of water, we'll pour within round plastic containers, and we'll put it within the hospital's refrigerator. Finally, we will prepare 4 pieces of ice with this method, which every 15 minutes will put one of these ices under the tongue of the patient, and we will ask him until its complete solution, do not swallow it. These ices will be used for an hour (a total of 4 pieces of ice).Intervention group: In the cardamom group, will be used 4 pieces of ice containing 6 drops of 10% cardamom extract, which will be ready like as peppermint extract.Intervention group: In the placebo group will be used 4 pieces of ice, without any additive substance, which will be ready in dimensions of two previous groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having nausea before the intervention; age over 18 years old; not sensitive to peppermint and cardamom extract. Exclusion criteria: discharge before the end of the intervention
Intervention groups
Three groups, ice group containing peppermint extract, ice group containing cardamom extract, and placebo group
Main outcome variables
nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170123032129N7
Registration date:2019-07-17, 1398/04/26
Registration timing:registered_while_recruiting
Last update:2019-07-17, 1398/04/26
Update count:0
Registration date
2019-07-17, 1398/04/26
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
2019-07-11, 1398/04/20
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of sucking ice containing peppermint extract with cardamom extract on prevention of nausea and vomiting after laparoscopic cholecystectomy in patients hospitalized to general surgery wards in Hamadan Besat hospital -2019. General surgery section of Besat Hospital in Hamedan at 2019 conducted a comparison study between sucking mint & cardamom flavored ice to avoid nausea & vomiting after laparoscopic cholecystectomy operation.
Public title
Comparison the effect of sucking ice containing peppermint extract with cardamom extract on prevention of nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old.To be more than 18 years old
Having nausea before the intervention. vomiting before intervention.
Not sensitive to peppermint and cardamom extract
Exclusion criteria:
Discharge before the end of the intervention.Release prior end of intervention process
Vomiting without nausea before or during the intervention.Vomiting not coupled with nausea before or meantime of intervention.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Using blocking method (three-block method), three letters A, B, and C with different permutations will be placed in blocks, then 35 blocks will be randomly selected, then participants will be assigned to three groups based on selected triple blocks.
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
2019-06-15, 1398/03/25
Ethics committee reference number
IR.UMSHA.REC.1398.233
Health conditions studied
1
Description of health condition studied
Cholecystitis
ICD-10 code
K80.0
ICD-10 code description
Calculus of gallbladder with acute cholecystitis
Primary outcomes
1
Description
nausea
Timepoint
1 and 3 hours after intervention
Method of measurement
visual analogue scale to measure severity of nausea
2
Description
Vomiting
Timepoint
1 and 3 hours after intervention
Method of measurement
Count of frequency of vomiting
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (ice containing peppermint extract): 6 drops of peppermint extract 10%, mixed with 1 cc of water will be poured inside round plastic containers, and will be put inside the hospital's refrigerator. then 4 pieces of ice will be put every 15 minutes under the tongue of the patient. Patient will be asked not to swallow it until complete solution. These ices will be used for an hour (a total of 4 pieces of ice).
Category
Prevention
2
Description
Intervention group (cardamom group): 4 pieces of ice containing 6 drops of 10% cardamom extract, will be prepared and administered similar to peppermint extract.
Category
Prevention
3
Description
Intervention group: In the placebo group will be used 4 pieces of ice, without any additive substance, which will be ready similar to two previous groups.
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
Hamadan
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 81 3838 0535
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