Determining the effect of topical use of rose oil in the stomach area on the severity of nausea and vomiting during pregnancy
Design
The clinical trial has a control group, with parallel groups, three blind strains, available sampling and the use of permutation blocks, the sample size will be 53 people in each group.
Settings and conduct
The location of the research was Ferdous City Social Security Clinic and sampling was done using the available method and using the permutation block method. They cover the stomach with 5 drops of the oil they have locally and without massage. This procedure will be continued three times a day, half an hour before meals, for one week. No intervention will be done in the control group. The researcher, the participants and the person responsible for analyzing the data will be unaware of the contents of each jar.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Normal pregnancy/gestational age 8-16 weeks/presence of mild to moderate nausea and vomiting based on the Rhodes index/thin, normal BMI range and weight gain based on pre-pregnancy BMI or before 12 weeks of pregnancy/insensitivity to rosehip compounds and edible liquid paraffin oil
Exit criteria:
- Occurrence of obstetrical problems such as miscarriage/suffering from severe nausea and vomiting during pregnancy/appearance of symptoms of allergy to rose oil or edible liquid paraffin oil.
Intervention groups
People will be assigned to three groups: intervention (rosehip oil), placebo (oral liquid paraffin oil) and control (no intervention).
Main outcome variables
severe nausea; severity of vomiting; burping intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240512061754N1
Registration date:2024-06-16, 1403/03/27
Registration timing:prospective
Last update:2024-06-16, 1403/03/27
Update count:0
Registration date
2024-06-16, 1403/03/27
Registrant information
Name
maryam moshfegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
m.moshfegh8627@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical use of rose oil in the stomach area on the severity of nausea and vomiting during pregnancy
Public title
The effect of topical use of rose oil in the stomach area on the severity of nausea and vomiting during pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent to participate in the study
Natural singleton pregnancy
Gestational age 8-16 weeks (based on ultrasound)
The presence of mild to moderate nausea and vomiting based on the Rhodes index
Non-smoking
Absence of mental problems or the use of psychiatric drugs
No stressful incident in the last 6 months
Thin, normal and overweight BMI ranges based on BMI before pregnancy or before 12 weeks of pregnancy
Absence of signs of threatened abortion
No urinary tract infection
No thyroid dysfunction
Absence of any digestive disease
Insensitivity to rose compounds according to mother's statement
Insensitivity to edible liquid paraffin oil according to the mother
Exclusion criteria:
- Occurrence of obstetrical problems (spotting, threat of abortion, etc.) during study
- Occurrence of nausea and vomiting due to causes other than pregnancy during the study as diagnosed by the doctor (including travel nausea and vomiting, overeating, gastrointestinal diseases; infectious, meningitis, influenza and other diseases that cause nausea and vomiting)
- Suffering from severe nausea and vomiting during pregnancy that requires treatment or hospitalization during the study
- Occurrence of symptoms of allergy to rose oil according to the mother's statement during the study
- The occurrence of allergy to edible liquid paraffin oil according to the mother's statement during the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
159
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to study groups using the permutation block method with a block size of 3. A randomization list will be generated by the analyzer before the study's commencement using the website "https://www.sealedenvelope.com".
This list will be sealed in opaque envelopes and provided to the researcher. Envelopes will be opened in the order of the entry of qualified participants into the study, and individuals will be allocated to the groups accordingly.
Blinding (investigator's opinion)
Triple blinded
Blinding description
ose oil and edible liquid paraffin oil will be packed in similar jars by Barij company, the jars will be marked with A, B labels by Barij company, and the participants, clinical care, researcher, outcome evaluator, data analyst from The contents of each jar will be unknown.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Islamic Republic Blvd., Shahid Gholam Hossein Imani St., Ferdous Social Security Clinic
City
Ferdows
Province
South Khorasan
Postal code
9771884633
Approval date
2024-03-12, 1402/12/22
Ethics committee reference number
IR.GMU.REC.1403.012
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Pregnancy nausea score and pregnancy vomiting score in Rhodes questionnaire
Timepoint
Before starting the intervention, daily during the intervention
Method of measurement
Rhodes Nausea and Vomiting Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, before the start of the intervention, in addition to the usual training on reducing nausea and vomiting of pregnancy according to the national protocol, it will be explained that after lying on the back, in the position of the stomach anatomically and in order to For the better understanding of the participants and according to the form provided to them, they will be taught that about 5 closed fingers above the navel, the upper middle and upper left part of the abdomen should be covered with oil, 5 drops of rose oil topically and Without massage, this procedure will continue three times a day, half an hour before meals for a week. Rosehip oil is the standard of Barij Essential Oil Company and it was prepared by Barij Essential Oil Company.
Category
Treatment - Drugs
2
Description
Control group: Before starting the intervention in this group, in addition to the usual education about reducing nausea and vomiting of pregnancy according to the national protocol, oral liquid paraffin oil will be given and it will be explained that after being placed in the position of lying on the back, in the place of being placed Stomach anatomically and in order to better understand the participants and according to the form provided to them, they will be taught that about 5 closed fingers above the navel, the upper middle and upper left part of the abdomen should be covered with oil, 5 drops of Edible liquid paraffin oil topically without massage, which will continue three times a day, half an hour before meals, for one week. Edible liquid paraffin oil is the standard of Barij Essential Oil Company and was prepared by Barij Essential Oil Company.
Category
Treatment - Drugs
3
Description
Control group: This group will only be given the usual education about reducing nausea and vomiting of pregnancy.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ferdows City Social Security Clinic
Full name of responsible person
Maryam Moshfegh
Street address
Islamic Republic Blvd., Shahid Gholam Hossein Imani St., Ferdous Social Security Clinic
City
Ferdows
Province
South Khorasan
Postal code
9771884633
Phone
+98 56 3272 6707
Email
m.moshfegh8627@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Narjes Bahri
Street address
Side of the Asian road
City
gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3815
Email
nargesbahri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Moshfegh
Position
Midwifery master's student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Islamic Republic Blvd., Shahid Gholam Hossein Imani St., Ferdous Social Security Clinic
City
ferdows
Province
South Khorasan
Postal code
9771884633
Phone
+98 56 3272 6707
Email
m.moshfegh8627@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Moshfegh
Position
Midwifery master's student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Islamic Republic Blvd., Shahid Gholam Hossein Imani St., Ferdous Social Security Clinic
City
ferdows
Province
South Khorasan
Postal code
9771884633
Phone
+98 56 3272 6707
Email
m.moshfegh8627@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Moshfegh
Position
Midwifery master's student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Islamic Republic Blvd., Shahid Gholam Hossein Imani St., Ferdous Social Security Clinic
City
Ferdows
Province
South Khorasan
Postal code
9771884633
Phone
+98 56 3272 6707
Email
m.moshfegh8627@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available