Objective: This study aimed to determine the effect of lemon aromatherapy is designed for nausea and vomiting of pregnancy in pregnant women. This study is an interventional study and design for the two groups (control group) with two pre-test and post-test. Community to pregnant women referred to health centers in Hamadan. Random sampling by allocation concealment with a numerical table random will be allocated to intervention and control groups. A sample is determined of 48 patients in the intervention group and 48 patients in the control group is determined.After completing the test group PUQE-24 questionnaire before the study for 4 and every day as soon as nausea and vomiting Cleaning cloth and poured two drops of lemon on Tuesday takes a deep breath and, if necessary, it is repeated five minutes later, and in the days PUQE-24 questionnaire complements. The primary outcome variable of nausea and vomiting and lemon aromatherapy is secondary outcome variables. Using descriptive and inferential statistics to compare the two groups will be discussed. SPSS20 software will be used for data analysis software.
General information
Acronym
effect Lemon aromatherapy on nausea and vomiting in pregnancy
IRCT registration information
IRCT registration number:IRCT201605026888N15
Registration date:2016-07-06, 1395/04/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-06, 1395/04/16
Registrant information
Name
Fatemeh Shobeiri
Name of organization / entity
Hamadan Universiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
shobeiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of Research Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy lemon on nausea and vomiting of pregnancy in pregnant women referred to health centers
Public title
The effect of aromatherapy lemon on nausea and vomiting of pregnancy in pregnant women referred to health centers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included women ages 16 to 40 years 6 to 16 weeks gestational age; ability to read and write; singleton pregnancy by ultrasound in health records; mild to moderate nausea with or without vomiting (minimum score of 3 and a maximum score of 12, based on relevant tools); non-use of anti-nausea or vomiting within the last 24 hours, non-smoking, lack of psychological disorder or traumatic event over the last 6 months; lack of molar pregnancy and symptoms of threatened abortion and diseases such as pyelonephritis, thyroid disorders, gastrointestinal disease or any other disease with nausea and vomiting show (according to the patient and medical examination center); having phone calls, lack of problem in the olfactory system (according to patient) exclusion criteria included symptoms of allergy or intolerance to lemon during the study, not wanting to continue the study; if you use other medications during the study
Age
From 16 days old to 31 days old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan Medical Sciences University ethics committee
Street address
Hamadan Medical Sciences University ethics committee
City
Hamedan
Postal code
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
IR.UMSHA.REC.1395.34
Health conditions studied
1
Description of health condition studied
Nausea and Vomiting
ICD-10 code
021
ICD-10 code description
Mild hyperemesis gravidarum
Primary outcomes
1
Description
nausea and vomiting
Timepoint
6-16 weeks of pregnancy
Method of measurement
PUQE-24 questionnaire.
Secondary outcomes
1
Description
Lemon aromatherapy
Timepoint
6-16 weeks of pregnancy
Method of measurement
Drops
Intervention groups
1
Description
Intervention Group:After obtaining informed consent from participants, For four days and each day as soon as nausea and vomiting by mother, two drops of lemon at a concentration of 2% of the company Barij Esans poured onto a clean tissue Three takes a deep breath and, if necessary, be repeated every five minutes and Per day once the questionnaire is completed by the cases..
Group control: For four days and each day as soon as nausea and vomiting by mother, two drops of placebo solution that is in the same container of lemon poured onto a clean tissue Three takes a deep breath and, if necessary, be repeated every five minutes.
Category
Treatment - Drugs
2
Description
Control group: After obtaining informed consent from participants, Mothers controlled group placebo(water) to be delivered within the bottle similar to the intervention group.For four days and each day as soon as nausea and vomiting by mother, Two drops of the contents of the glass poured onto a clean tissue Three takes a deep breath and, if necessary, be repeated every five minutes and Per day once the questionnaire is completed by the control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center Samii 2
Full name of responsible person
Fahimeh Ezzati arasteh
Street address
Taleghani street, alley Mirzaee
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Hamedan University of Medical Sciences
Full name of responsible person
doctor Saeed Bashirian
Street address
Street Shahid Fahmideh, Hamedan University Medical Sciences, Research and Technology Deputy Hamedan
City
Hamedan
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 and Technology Hamedan 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
Hamedan Medical Sciences University
Full name of responsible person
Fatemeh Shobeiri
Position
PhD Maternal and Child Health / Associate Professor
Other areas of specialty/work
Street address
treet Shahid Fahmideh, Faculty of Nursing, Hamedan Medical Sciences University
City
Hamedan
Postal code
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan Medical Sciences University
Full name of responsible person
Fatemeh Shobeiri
Position
PhD Maternal and Child Health / Associate Professor
Other areas of specialty/work
Street address
treet Shahid Fahmideh, Faculty of Nursing, Hamedan Medical Sciences University
City
Hamedan
Postal code
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan Medical Sciences University
Full name of responsible person
Fatemeh Shobeiri
Position
PhD Maternal and Child Health / Associate Professor
Other areas of specialty/work
Street address
treet Shahid Fahmideh, Faculty of Nursing, Hamedan Medical Sciences University
City
Hamedan
Postal code
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)