This is a double blind clinical trial to evaluate the effect of supermint oil on nausea & vomiting of pregnancy in prenatal ward at health clinics of Babol University. Eighty pregnant women who suffer from nausea & vomiting of pregnancy will be selected according to inclusion and exclusion criteria and will be divided into two groups (supper mint oil and placebo) randomly. Super mint group will put a glass of water containing 4-6 drops of super mint oil beside their bed before sleeping during 4 nights, in addition to getting routine educations about decreasing nausea & vomiting. In control group, normal saline will be used in the same way as the placebo. Nausea intensity will be evaluated by VAS (Visual Analog Scale) and vomiting intensity will be evaluated by counting the vomiting number per day.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810163004N1
Registration date:2010-05-29, 1389/03/08
Registration timing:na
Last update:
Update count:0
Registration date
2010-05-29, 1389/03/08
Registrant information
Name
Fereshteh Behmanesh
Name of organization / entity
Babol university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1322 5585
Email address
midwifery@mubabol.ac.ir
Recruitment status
Not enough for processing
Funding source
Babol university of medical sciences
Expected recruitment start date
2009-10-12, 1388/07/20
Expected recruitment end date
2009-07-11, 1388/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of super mint oil on nausea & vomiting of pregnancy, Babol, 2009
Public title
Evaluation the effect of suppermint oil on nausea & vomiting of pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18-35 years old, single pregnancy, first trimester of pregnancy.
Exclusion criteria: pregnant women with other diseases or hypertension of pregnancy, dead fetus or diagnosed malformation of fetus, hyper emesis gravidarum, multiple pregnancy and molhydatiform.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol university of medical sciences
Street address
Kargar square
City
Babol
Postal code
Approval date
2010-01-17, 1388/10/27
Ethics committee reference number
5330
Health conditions studied
1
Description of health condition studied
pregnancy nausea & vomiting
ICD-10 code
O21.9
ICD-10 code description
Vomiting of pregnancy, unspecified
Primary outcomes
1
Description
pregnancy nausea & vomiting
Timepoint
18 days
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Wellbeing of pregnancy
Timepoint
1 month
Method of measurement
Questionnaire
Intervention groups
1
Description
In intervention group: using 4-6 drops of suppermint oil in water bowl and putting it beside the bed before sleeping
Category
Other
2
Description
In control group: using 4-6 drops of normal saline in water bowl and putting it beside the bed before sleeping
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Healthy centers of Babol University of Medical Sciences
Full name of responsible person
Fereshteh Behmanesh
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol univarsity of medical sciences
Full name of responsible person
Amrolah Mostafazadeh
Street address
Vice chancellor for research, Babol University of Medical Sciences
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol univarsity 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
Babol univarsity of medical sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Msc in midwifery/Faculty member
Other areas of specialty/work
Street address
Babol univarsity of medical sciences midwifery group
City
Babol
Postal code
Phone
+98 11 1322 5585
Fax
Email
f24farzan45@gmail.com - midwifery@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol univarsity of medical sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Msc in midwifery
Other areas of specialty/work
Street address
Babol univarsity of medical sciences midwifery group
City
Babol
Postal code
Phone
+98 911 213 5312
Fax
Email
f24farzan@yahoo.com - f24farzan45@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol univarsity of medical sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Msc in midwifery/faculty member
Other areas of specialty/work
Street address
Babol univarsity of medical sciences
City
Babol
Postal code
4718779969
Phone
+98 11 1322 5585
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)