Objective: Determine the effect of inhalation of lavender on nausea and vomiting and pain after hernia surgery
Study design: Randomized triple-blind study, Two group (experimental and control group) before and after
Population: Patients undergoing ventral (abdominal) hernia
Inclusion criteria: Avoiding use of drugs that causes nausea and vomiting up to two days before surgery; patients in the age range 65-18 years; lack of chronic obstructive pulmonary disease
Exclusion criteria: Addiction to drugs such as opium, morphine that affect nausea and vomiting; a history of allergies and sensitivities to lavender; pre-operative nausea and vomiting
Sample size: 110
Interventions: Six liters per minute of oxygen via a face mask combined with lavender essential oil for 20 minutes
Intervention time: After entering patient to postoperative care unit (PACU) after surgery
Main outcome measures (variables): Nausea, Vomiting, Pain of surgery site
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602103064N1
Registration date:2016-06-25, 1395/04/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-25, 1395/04/05
Registrant information
Name
Hossein Bagheri
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
bagheri@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shahroud University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey and comparison the effect of inhalation of lavender on nausea, vomiting and pain after hernia surgery
Public title
Survey and comparison the effect of inhalation of lavender on nausea, vomiting and pain after hernia surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Avoiding use of drugs that causes nausea and vomiting up to two days before surgery; patients in the age range 65-18 years; lack of chronic obstructive pulmonary disease
Exclusion criteria: Addiction to drugs such as opium, morphine that affect nausea and vomiting; a history of allergies and sensitivities to lavender; pre-operative nausea and vomiting
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In the present study, due to very light smell of lavender and because after anesthesia patient is totally unconsciousness when receiving inhaled lavender and also 4 drops of essential oil of lavender will be diluted with oxygen, therefore, the smell of lavender is not recognizable for patient. On the other hand, data collector and data analyst (trained staff) will be unaware of groups (experimental and control group). Therefore, this is a triple-blind study.
In this study, randomly and based on the software (allocation), will be placed patients in experimental group (oxygen with lavender group) and control group (oxygen without lavender or routine group).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Hafte-Tir square, Shahrood University of Medical Sciences
City
Shahroud
Postal code
3614773955
Approval date
2016-06-18, 1395/03/29
Ethics committee reference number
IR.SHMU.REC.1395.41
Health conditions studied
1
Description of health condition studied
Inguinal hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
2
Description of health condition studied
Femoral hernia
ICD-10 code
K41
ICD-10 code description
Femoral hernia
3
Description of health condition studied
Umbilical hernia
ICD-10 code
K42
ICD-10 code description
Umbilical hernia
4
Description of health condition studied
Ventral hernia
ICD-10 code
K43
ICD-10 code description
Ventral hernia
Primary outcomes
1
Description
Nausea
Timepoint
The time of patient exit from recovery: 2, 6 and 24 hours after intervention study
Method of measurement
Visual analogue scale VAS
2
Description
Vomiting
Timepoint
Time patient leaving recovery room, 2, 6 and 24 hours after anesthesia
Method of measurement
Visual Analogue Scale (VAS)
3
Description
Pain of surgery site
Timepoint
Time patient leaving recovery room, 2, 6 and 24 hours after anesthesia
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
For each of subjects in the experimental group, 4 drops of lavender oil will add to oxygen container in recovery room and oxygen will be prescribed through a face mask combined with lavender essential oil at a rate of six liters per minute for 20 minutes
Category
Treatment - Drugs
2
Description
For each of subjects in the control group, oxygen will be prescribed through a face mask without lavender essential oil at a rate of six liters per minute for 20 minutes.