This study is a randomized single-blind controlled clinical trial that aimed to determine the effects of inhaling peppermint aroma on the severity of nausea and vomiting of pregnancy that will include 56 pregnant women (28 patients in the intervention group and 28 patients in the control group) with following criteria : Age18 to 35 years, Iranian and has the ability to read and write, basic level of nausea and vomiting according to (PUQE) questionnaire before intervention in range mild to moderate (points 12-3), 6 to 20 weeks of gestational age, non-smoker and non-alcoholic, lack of sensitivity to herbal medicines according to her manifest. Pregnant women in the event of severe nausea and vomiting of pregnancy, allergic to peppermint oil and signs of threatened abortion will be excluded. In both groups, inhaling aromatherapy will be done over a period of four days. Women in intervention group at the time of nausea will pour 5 drops of Peppermint essential oil on a cotton ball and put it 0.5 centimeter below their nose then will inhale three deep breaths through the nose. Aromatherapy in the control group will perform similarly with sweet almond oil. Finally, to determine the severity of nausea and vomiting, pregnant women will fill out PUQE questionnaire at the end of each day and will deliver them to the researcher after the end of the intervention period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412043860N9
Registration date:2014-12-31, 1393/10/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-12-31, 1393/10/10
Registrant information
Name
Gity Ozgoli
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
gozgoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination the effect of inhaled peppermint aroma on the severity of nausea and vomiting of pregnancy in women
Public title
Effect of peppermint aroma on the severity of nausea and vomiting of pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
nclusion criteria: Age 18-35 years, Iranian and has the ability to read and write, Basic severity of nausea and vomiting according to (PUQE) questionnaire before intervention in range mild to moderate (score 3-12), 6 to 20 weeks of gestational age (based on the first day of the last menstrual period or first trimester sonography), Having at least one sonography to determine the number and health of the fetus, Wanted pregnancy, The lack of sense of smell problems, A normal single pregnancy in every respect and without a history of obstetric complications during pregnancy (no symptoms of threatened abortion, lack of molar pregnancy), Healthy pregnant women without a history of known diseases according to the information in the maternal health file, Non-smoker and non-alcoholic, Lack of sensitivity to herbal medicines according to her, Avoiding the use of any chemical or herbal antiemetics during the 24 hours before the start of study, Lack of mental health problems and disaster during the six months before the start of study according to her. Exclusion criteria: Severe nausea and vomiting of pregnancy (scoring 13 or higher according to PUQE questionnaire)during the study period, Allergic to peppermint essential oil or peppermint fragrance intolerance, Use any chemical or herbal antiemetics, Aromatherapy less than three times during the day, Signs and symptoms of threatened abortion during the study period, Unwillingness to continue to participate in the studExclusion criteria: severe nausea and vomiting of pregnancy (scoring 13 or higher according to PUQE questionnaire), allergic to peppermint oil or peppermint fragrance intolerance, use any chemical or herbal anti-nausea medication, signs and symptoms of threatened abortion during the study period, unwillingness to continue to participate in the study.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, next to Talqany hospital, Yaman street, Shahid Chamran highway, Tehran
City
Tehran
Postal code
1985717443
Approval date
2014-11-23, 1393/09/02
Ethics committee reference number
161
Health conditions studied
1
Description of health condition studied
Nausea and vomiting of pregnancy
ICD-10 code
O21.0
ICD-10 code description
Mild hyperemesis gravidarum
Primary outcomes
1
Description
severity of nausea and vomiting of pregnancy
Timepoint
Before the intervention, after the intervention at the end of each day for 4 days.
Method of measurement
The Pregnancy Unique Quantification of Emesis/Nausea questionnaire
Secondary outcomes
1
Description
Satisfaction of the treatment course
Timepoint
At the end of intervention period ( after 4 days)
Method of measurement
Researcher made questionnaire at the end of intervention
2
Description
Possible side effects of intervention
Timepoint
At the end of intervention period ( after 4 days)
Method of measurement
Researcher made questionnaire at the end of intervention
Intervention groups
1
Description
Intervention group: In this group, Aromatherapy with Peppermint essential oil will be done for 4 days. Pregnant women will inhale 1 milliliter of bottle content (containing 2 drops of peppermint essential oil) daily in 4 times and each time 5 drops.
Category
Treatment - Drugs
2
Description
Control group: The method of aromatherapy in the control group will be the same as intervention group with the difference that in this group sweet almond oil will be used alone.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Research Deputy of Nursing and Midwifery College, dr Simbar M
Street address
Vice Chancellor for research of Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Joulaee rad
Position
Graduate student of midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
Email
sbnmf@sbmu.ac.ir ; n.joulaeerad@yahoo.com
Web page address
http://nm.sbmu.ac.ir/?siteid=244
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gity Ozgoli
Position
Assistant Professor of Reproductive health
Other areas of specialty/work
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 218865536671
Fax
+98 21 8820 2521
Email
sbnmf@sbmu.ac.ir ; g.ozgoli@gmail.com
Web page address
http://nm.sbmu.ac.ir/?siteid=244
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)