Objectives: The aim of this study is comparison of the effect of aromatherapy Lavender and Peppermint on nausea, vomiting and anxiety in pregnant women. Design: This randomized clinical trial; single-center; placebo-controlled included 99 pregnant women who will be referred to the prenatal care clinic. Participants randomly will be allocated into 2 interventions and a control group (placebo). Inclusion criteria: Pregnant women in 6 to 16 weeks of gestational age with a mild to moderate nausea and vomiting; single pregnancy with an alive and healthy fetus according to the Ultrasound. Exclusion criteria: not to have any tendency to continue participating in the study; severe nausea and vomiting that needs to use drugs. Researcher explains routine cares to participants. Participants in two intervention groups will be dropped Lavender or Peppermint oil (made by Barij Company) on a piece of cotton pad and will attach to their dress collar within 20 cm distance from nose and they will breathe normally for 20 minutes. This process continues 2 times a day for 1week. The control group does the same process with placebo instead. Main outcome: nausea, vomiting and anxiety. Rhodes index questionnaire that include 8 questions will be given to all participants to be complete before bedtime. Alsoby STAIT anxiety questionnaire will be completed by the research assistant before and at the end of the interventions. The scores will be calculate and compared together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306082324N12
Registration date:2014-09-23, 1393/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-23, 1393/07/01
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1813
Email address
keshavarz@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2014-06-05, 1393/03/15
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Lavender and Mint oil on nausea, vomiting and anxiety in pregnant women
Public title
Comparison the effect of Lavender and Mint oil on nausea, vomiting and anxiety in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age 6-16 weeks based on LMP or Ultrasound; Age 15-34 year ; Having mild to moderate nausea and vomiting (based on Rhodes index); Ashpylberger Anxiety Scale scores will obtained from less than 53 in state anxiety; Single pregnancy with an alive and healthy fetus based on ultrasound; Ability to read and write; No olfactory disorder (according to pregnant women reporting); Not having physical, mental and emotional diseases; Lack of stressful events during the past 6 months; Not to have any allergy to herbal drugs; Not using anti emetic or emetic drugs( herbal or chemical drugs) over the previous 24 hours; lack of sedative drugs or other therapeutic measures (such as the use of vegetable oils, regular exercise) to reduce anxiety before six weeks; Desire for pregnancy. Exclusion criteria: Not to have tendency to continue participating in the study; Crises and stressful events during the study; Lack of regular use of aromatherapy; Other signs like diarrhea that show nausea and vomiting are pathological; Each disease which makes or increases nausea and vomiting; Use drugs during study; Alergy during aromatherapy.
Age
From 15 years old to 34 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
99
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
Ethical commitment of Tehran University of Medical Sciences
Street address
Sixth floor, Central office, Ghods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2014-02-17, 1392/11/28
Ethics committee reference number
2478/130/ص/92
Health conditions studied
1
Description of health condition studied
Nausea and vomiting of pregnancy
ICD-10 code
Z34.9
ICD-10 code description
Supervision of normal pregnancy, unspecified
2
Description of health condition studied
Anxiety in Pregnancy
ICD-10 code
F40, F41,
ICD-10 code description
Neurotic, stress-related and somutoform disorders
Primary outcomes
1
Description
vomiting distress
Timepoint
every 24 hours
Method of measurement
Rhodez index
2
Description
anxiety
Timepoint
before intervention and one week after the intervention (End of intervention)
Method of measurement
Spielberg State Anxiety Inventory questionnaire.
3
Description
duration of nausea
Timepoint
every 24 hours
Method of measurement
Rhodes index
4
Description
frequency of nausea
Timepoint
every 24 hours
Method of measurement
Rhodes index
5
Description
distress from retching
Timepoint
every 24 hours
Method of measurement
Rhodes index
6
Description
frequency of retching
Timepoint
every 24 hours
Method of measurement
Rhodes index
7
Description
amount of vomiting
Timepoint
every 24 hours
Method of measurement
Rhodes index
8
Description
distress of nausea
Timepoint
every 24 hours
Method of measurement
Rhodes index
9
Description
frequency of vomiting
Timepoint
every 24 hours
Method of measurement
Rhodes index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Participants will be dropped Lavender oil (made by Barij Company) on a piece of cotton pad and will attach to their dress collar within 20 cm distance from nose and they will breathe normally for 20 minutes. This process continues 2 times a day for 1week.
Category
Treatment - Drugs
2
Description
intervention group 2: Participants will be dropped Mint oil (made by Barij Company) on a piece of cotton pad and will attach to their dress collar within 20 cm distance from nose and they will breathe normally for 20 minutes. This process continues 2 times a day for 1week
Category
Treatment - Drugs
3
Description
control group(placebo): Participants will be dropped Sesame oil (made by Barij Company) on a piece of cotton pad and will attach to their dress collar within 20 cm distance from nose and they will breathe normally for 20 minutes. This process continues 2 times a day for 1week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharloo hospital
Full name of responsible person
Maryam keshavarz
Street address
Behdari St, Rah Ahan Sq
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr Fotoohi Akbar
Street address
Sixth floor, Central office, Ghods St, Keshavarz Blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran 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
Tehran University of Medical Science
Full name of responsible person
Azam Amzajerdi
Position
MA
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat ST, Tohid Sq, Tehran
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
Azamamzajerdi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam keshavarz
Position
Assistant Professor in Midwifery education
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Rashid Yasami Av, Upper Vanak Sq, Vali-e-Asr St,Tehran
City
Tehran
Postal code
Phone
+98 21 6105 4219
Fax
Email
Keshavarz.m@iums.ac.ir ; m_keshir@yahoo.com
Web page address
www.fnm.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Maryam keshavarz
Position
Assistant Professor in Midwifery education
Other areas of specialty/work
Street address
Midwifery dep, School of Nursing Midwifery, Tehran University of Medical Sciences, West Nosrat St,Tehran
City
Tehran
Postal code
Phone
+98 21 6105 4219
Fax
+98 21 6690 4252
Email
keshavarz@iums.ac.ir ; m_keshir@yahoo.com
Web page address
www.fnm.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)