This clinical trial is performed on 120 patients admitted in the surgical ward of Imam Reza Hospital of Kermanshah. During this randomized clinical trials, the sample of research included abdominal surgery patients who experienced nausea in addition of other entrance criterion to be included in the study. First, the samples are chosen consciously and special features are recorded on an observational paper then, randomly divide into three groups(two intervention group and a control group). In the first group that received inhalation aromatherapy, we Used the solution that contains Peppermint extract(0/2 ml of peppermint solution 10% in 2 ml of distilled water) for 5 minute. In the other group that received inhalation aromatherapy, we used the solution that contains Peppermint extract(0/2 ml of peppermint solution 30% in 2 ml of distilled water) for 5 minute.The Desired solutions(0/2 ml of peppermint solution in 2 ml of distilled water) were shed on the non Sterile gaz and the non sterile gazis subjected to the patient's nose in a distance of 5 cm for 5 minutes. This done after patient transferring from operating room to the surgical ward and stabilizing their vital signs. Nausea severity is Measured 5 and 10 min after the intervention. In the control group, at the same intervals, distilled water is used. Before and after intervention, nausea severity is measured in each group and comparison is done between 3 group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041417267N1
Registration date:2014-05-25, 1393/03/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-25, 1393/03/04
Registrant information
Name
Jahangir Rezaie
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1828 2102
Email address
j-rezaie@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of inhalation aromatherapy on nausea severity in patients admitted for abdominal surgery
Public title
The effect of peppermint on nausea severity.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients has been undergoing abdominal surgery; Having a good sense of smell(Ability to detect the scent of peppermint); Ages between 15 to 65 years; Having a good eyesight(to detect the severity of nausea on VAS); Having consciousness; Not suffering from asthma and other allergic diseases; Non-smoking; Receiving a type of anesthesia(general); Receiving a group of drug during anesthesia(Nesdonal and Isoflurane). Exclusion Criteria: Patient with lack of cooperation during the study; Loss of consciousness; Receiving Antiemetic drugs; Receiving narcotic drug(Morphine and Pethidine)during the study.
Age
From 15 years old to 65 years old
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)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Postal code
6777136866
Approval date
2014-03-04, 1392/12/13
Ethics committee reference number
1691
Health conditions studied
1
Description of health condition studied
Nausea
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Nuasea severity
Timepoint
Before the intervention, 5 and 10 minutes after intervention
Method of measurement
Visual Analog Scale to assessment of nausea
Secondary outcomes
empty
Intervention groups
1
Description
In this study the researcher, after patients transferring from operating room to the surgical ward and stabilizing their vital signs performs the intervention between 2 groups. In the first group that received inhalation aromatherapy,we used the solution that contains Peppermint extract(0/2 ml of peppermint solution 10% in 2 ml of distilled water) for 5 minute. In the other group that received inhalation aromatherapy, we used the solution that contains Peppermint extract(0/2 ml of peppermint solution 30% in 2 ml of distilled water) for 5 minute.The Desired solutions(0/2 ml of peppermint solution in 2 ml of distilled water) were shed on the non Sterile gaz and the non sterile gaz is subjected to the patient's nose in a distance of 5 cm for 5 minutes.
Category
Treatment - Other
2
Description
In the control group, distilled water is used. two ml of distilled water were shed on the non Sterile gaz and the non sterile gaz is subjected to the patient's nose in a distance of 5 cm for 5 minutes. Nausea severity is measured 5 and 10 min after the intervention with VAS(Visual Analog Scale) in control group and comparison is done between 3 group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Kermanshah
Full name of responsible person
Yasin Ahmadi
Street address
Imam Reza Hospital, Nurse Blvd, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Research and Technology Affair, No 2 Building, Shahid Beheshti Blvd,
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Yasin Ahmadi
Position
Nurse
Other areas of specialty/work
Street address
Shahid Ahmadi Alley,Shahid Rajaie Street, Salas Babajani, Kermanshah
City
Salas Babajani
Postal code
67771-36866
Phone
+98 932 672 2330
Fax
+98 83 2722 5254
Email
mallagyan492@gmail.com;
sobaydarin@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Yasin Ahmadi
Position
Nurse
Other areas of specialty/work
Street address
Shahid Ahmadi Alley,Shahid Rajaie Street, salas babajani
City
Salas Babajani
Postal code
67771-36866
Phone
+98 83 2672 2330
Fax
+98 83 2722 5254
Email
mallagyan492@gmail.com;sobaydarin@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Yasin Ahmadi
Position
Nurse
Other areas of specialty/work
Street address
Shahid Ahmadi Alley,Shahid Rajaie Street, Salas Babajani
City
Salas Babajani
Postal code
67771-36866
Phone
+98 83 2672 2330
Fax
Email
mallagyan492@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)