The aim of this study is to determine the effect of lemon inhaler aromatherapy on nausea and vomiting of pregnancy. We will recruit pregnant woman from the
public health centers in Birjand, Iran. Pregnant woman that have eligible criteria will compelet PUQE-24 questionnaire which assess the severity of nausea and vomiting over the previous 24 hour. After getting written informed consent, we will randomly allocate them into intervention and control groups with assignment ratio of 1:1 using permuted block randomization with block sizes of four and six.
For allocation of concealment we will use in sequentially numbered identical containers that are administered serially to participants. In this study we keep blinding for participants and researcher.
in two group Once the feeling of nausea 2 drop of solution are placed on the cotton and held 3 cm under nose. Participant were instructed to take three slow, deep breaths and if necessary, repeat it after 5 minute. The participant will compelet PUQE-24 questionnaire daily during 4 days of intervation and at the end of intervention, researcher will complete the final questionnaire and the difference of mean in severity of nausea and vomiting are compared before and after of intervention and among two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202297418N2
Registration date:2012-05-10, 1391/02/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-05-10, 1391/02/21
Registrant information
Name
Parisa Yavarikia
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
yavarikiap@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Nursing and Midwifery Faculty of Tabriz University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lemon inhaler aromatherapy on nausea and vomiting of pregnancy: A randomised controlled trial
Public title
The effect of lemon inhaler aromatherapy on nausea and vomiting of pregnancy: A randomised controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 16 to 40 years old; Singleton and normal pregnancy with 6 to16 weeks based on LMP and ultrasound; Being able to compelet questionnaire; Having mild to moderate nausea and vomiting without hyperemesis gravidarum symptoms (based on 3-12 PUQE-24 scores); Not using anti emetic or emetic drugs( herbal or chemical drugs) over the previous 24 hour; Not having psychological problems and unpleasant event over 6 months ago according to pregnant women reporting; Not using tobacco; Not having molar pregnancy; Not having symptoms of Threatened abortion; Not having acute Pyelonephritis; Not having thyroid dysfunction; Not having identified digestive diseases which may cause nausea and vomiting; Having phone; No olfactory disorder. Exclusion criteria: Alergy during aromatherapy; use anti emetic herbal or chemical drugs during study
Age
From 16 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
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
Research Deputy of Tabriz University of Medical Sciences
Street address
Tabriz- Golgasht st-Tabriz University Of Medical Sciences-No 2 Building -3 floor -Deputy Of Research
City
Tabriz
Postal code
51665118
Approval date
2012-03-12, 1390/12/22
Ethics committee reference number
916
Health conditions studied
1
Description of health condition studied
Nausea and vomiting of pregnancy
ICD-10 code
O21.0
ICD-10 code description
Hyperemesis gravidarum, mild or unspecified, starting before the end of the 22nd week of gestation
Primary outcomes
1
Description
Severity of nausea and vomiting of pregnancy
Timepoint
Before and during intervention
Method of measurement
24-hour Pregnancy Unique Quantification of Emesis
Secondary outcomes
1
Description
Side effects
Timepoint
After intervention
Method of measurement
Final questionnaire
2
Description
Satisfaction
Timepoint
After intervention
Method of measurement
Final questionnaire
Intervention groups
1
Description
Intervention group:Aromatherapy with essential oil, Once the feeling of nausea 2 drop of solution are placed on the cotton and held 3 cm under nose. Participant were instructed to take three slow, deep breaths and if necessary, repeat it after 5 minute.
Category
Other
2
Description
Control group:The use of placebo(normal salin): Once the feeling of nausea 2 drop of solution are placed on the cotton and held 3 cm under nose. Patients were instructed to take three slow, deep breaths and if necessary, repeat it after 5 minute.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra health care center
Full name of responsible person
Farzaneh Safajou
Street address
21 Kargar street
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Golgashat Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Farzaneh Safajou
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati street
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
fsafajo@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Parisa Yavarikia
Position
Master of Sciences in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati street
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
yavarikiap@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)