Objective: determine the effect of combined inhaler aromatherapy (lemon and peppermint) on nausea and vomiting of pregnancy. Design: this study is a randomized controlled trial. Setting and conduct: this study is carried out on pregnant women from the public health centers in Birjand, Iran. Eligible patients who tended to participate are asked to answer the PUQE-24 questionnaire, related to the assessment of NVP in past 24 hours, and if their scores be mild to moderate, after taking written informed consent, will be asked to fill out questionnaire about their demographic and FSS questionnaire. Allocating the participants in the two groups will be done in the random allocation method using computerized random number table and the four and six blocking method with allocation ratio of 1:1. For allocation concealment, dark and similar packaged containers sequentially numbered from one will be used. It will be executed by a person uninvolved in the study. The researcher and participants will be unaware of the content of the containers. The participant will complete PUQE-24 questionnaire daily during 4 days of intervention and at the end of intervention, FSS and final questionnaire will be completed. Participants: 90 Pregnant women with Singleton and normal pregnancy with 6 to16 weeks gestation; With mild to moderate nausea with or without vomiting (based on 3-12 PUQE-24 scores); Without any antiemetic or emetic drug use in the past 24 hours; Without tobacco use; Without psychological problems and unpleasant event during last 6 months; pregnancy without signs of molar pregnancy and threatened abortion and any other dis¬ease with nausea and vomiting as a symptom. Interventions: the participants in both groups when feel nausea, place 3 drops of solution on the cotton, and keep it in distance of 3cm of their nose, and then breathe three times deeply through the nose and If necessary repeat it five minutes later. Main outcome measures variables: Severity of nausea and vomiting of pregnancy and fatigue.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014062914324N2
Registration date:2014-09-03, 1393/06/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-09-03, 1393/06/12
Registrant information
Name
Farzaneh Safajou
Name of organization / entity
Birjand University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 56 1442 2113
Email address
fsafajo@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Birjand University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined inhaler aromatherapy on nausea and vomiting of pregnancy: A randomised controlled trial
Public title
The effect of combined inhaler aromatherapy on nausea and vomiting of pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women who are 16 to 40 years old, with 6 to16 weeks gestation; With literacy; With Singleton pregnancy; With mild to moderate nausea with or without vomiting (based on 3-12 PUQE-24 scores); Without any antiemetic or emetic drug use in the past 24 hours; Without tobacco use; Without psychological problems and unpleasant event during last 6 months; Pregnancy without signs of molar pregnancy and threatened abortion and pyelonephritis, thyroid dysfunction and digestive diseases and any other dis¬ease with nausea and vomiting as a symptom (vomiting according to pregnant women and physician examination); With phone number; Without olfactory disorder (according to patient). Exclusion criteria: Allergy or drug intolerance during intervention; Unwillingness to continue the study; using other drugs during the study.
Age
From 16 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Ethics committee of Birjand University of Medical Sciences
Street address
Ghafari street, Birjand University of Medical Siences
City
Birjand
Postal code
Approval date
2014-07-05, 1393/04/14
Ethics committee reference number
1393-04-02
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 fatigue
Timepoint
Before and after intervention
Method of measurement
FSS questionnaire
2
Description
Severity of nausea and vomiting of pregnancy
Timepoint
Before and during intervention
Method of measurement
PUQE-24 questionnaire
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 combined lemon and peppermint essential oil, participants when feel nausea, place 3 drops of solution on the cotton, and keep it in distance of 3cm of their nose, and then breathe three times deeply through the nose
Category
Treatment - Drugs
2
Description
Control group:Aromatherapy with placebo, participants when feel nausea, place 3 drops of solution on the cotton, and keep it in distance of 3cm of their nose, and then breathe three times deeply through the nose
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health care center number 3
Full name of responsible person
Farzaneh Safajou
Street address
21 Kargaran street, Kargaran street
City
Birjand
2
Recruitment center
Name of recruitment center
Health care center number 4
Full name of responsible person
Farzaneh Safajou
Street address
Sajad Shahr, Ghadir Blvd
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Birjand University of Medical Sciences
Full name of responsible person
Dr Asghar Zarban
Street address
Gafari street, Birjand University of Medical Siences, Vice chancellor for research
City
Birjand
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, Birjand 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
Birjand University of Medical Siences
Full name of responsible person
Farzaneh Safajou
Position
Master of Sciences in midwifery
Other areas of specialty/work
Street address
Ghafari street, Birjand University of Medical Siences, Faculty of Nursing and Midwifery
City
Birjand
Postal code
Phone
+98 56 1882 5000
Fax
+98 56 1443 0076
Email
fsafajou@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Siences
Full name of responsible person
Farzaneh Safajou
Position
Master of Sciences in midwifery
Other areas of specialty/work
Street address
Ghafari street, Birjand University of Medical Siences, Faculty of Nursing and Midwifery
City
Birjand
Postal code
Phone
+98 56 1882 5000
Fax
+98 56 1443 0076
Email
fsafajou@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Siences
Full name of responsible person
Farzaneh Safajou
Position
Master of Sciences in midwifery
Other areas of specialty/work
Street address
Ghafari street, Birjand University of Medical Siences, Faculty of Nursing and Midwifery
City
Birjand
Postal code
Phone
+98 56 1882 5000
Fax
+98 56 1443 0076
Email
fsafajou@bums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)