The effect of citrus aurantium essential oil on the severity of pain in the first and second stages of labor and childbirth Satisfaction with delivery in primegravida women
the effect of Spring orange essential oil on the severity of pain in the first and second stages and satisfaction of childbirth
Design
the researcher will start sampling available (easy) after obtaining the informed consent of the eligible women. The research units will then be assigned to two intervention and control groups using quadruple blocks.
Settings and conduct
In Allameh Behlool Gonabadi Hospital, the samples were randomly assigned to one of the two experimental or control groups. After obtaining informed consent at the beginning of the active delivery phase (3-4 cm dilatation) in the intervention group, 4 ml of spring orange essential oil is poured on the absorbable, odorless and one-size napkin and attached to the collar of their clothes with a pin. In the control group, instead of spring essential oil, distilled water is given to mothers.
Participants/Inclusion and exclusion criteria
Nulliparous or multi gaviid one to three; age between 18-18 years old; education in reading and writing; pregnancy age between 40-38 weeks; live embryo; single, ceramic display and without abnormalities; fetal weight between 4000-2500 g; uterine contractions spontaneously; cervical dilatation 5-4 cm; healthy embryonic embryos; no clear pelvic stenosis; fetal heart rate in the normal range; lack of a history of diseases such as heart disease, diabetes, .....; no history of pregnancy problems and complications such as hypertension, preeclampsia …; no history of mental disorders; no addiction to drugs; absence of cesarean section or stimulation of labor pains; lack of olfactory problems and sensitivity to herbal medicines, not taking certain medications.
Intervention groups
Giving spring orange essential oil to participants in the intervention group and giving distilled water to research units in the control group.
Main outcome variables
The severity of labor pains and childbirth satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190123042469N2
Registration date:2020-06-13, 1399/03/24
Registration timing:registered_while_recruiting
Last update:2020-06-13, 1399/03/24
Update count:0
Registration date
2020-06-13, 1399/03/24
Registrant information
Name
Sedighesadat Kazeminia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4467 1441
Email address
kazemigh60@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-22, 1399/03/02
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of citrus aurantium essential oil on the severity of pain in the first and second stages of labor and childbirth Satisfaction with delivery in primegravida women
Public title
The effect of spring orange essential oil on the severity of pain and maternity satisfaction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Nulliparous or Multi Gravid are one to three
The age should be between 35-18 years.
Pregnancy based on early pregnancy or LMP ultrasound between 40-38 weeks.
The weight of the fetus should be between 4000-2500 grams according to Johnson's law.
The uterine contractions have started automatically. Alternate every 5 to 10 minutes and the duration is 20 to 35 seconds.
Cervical dilatation should be 5-4 cm.
The fetal membranes are healthy or if the rupture of the mammals is not more than 12 hours after the rupture of the mammals.
It should not be obvious in the examination of pelvic stenosis.
The fetal heart rate should be in the normal range and there should be no abnormal pattern of heart rate.
History of diseases such as heart disease, diabetes, hypertension, name, anemia, hepatitis
No history of pregnancy problems and complications such as hypertension, preeclampsia, no threat of miscarriage.
No history of mental disorders.
Odor problems and sensitivity to herbal medicines, do not have perfumes according to the person's opinion.
Do not take any special medicine.
Exclusion criteria:
Prohibited for normal delivery
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Research units are not informed of their placement in one of the study groups.
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
Imam Street, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2020-01-27, 1398/11/07
Ethics committee reference number
IR.GMU.REC.1398.151
Health conditions studied
1
Description of health condition studied
The severity of pain and the satisfaction of childbirth
ICD-10 code
O60-75
ICD-10 code description
Complications of labour and delivery
Primary outcomes
1
Description
The severity of labor pains
Timepoint
From the beginning of the active phase of labor until the end of the second stage of labor
Method of measurement
Visual scale of pain
2
Description
Childbirth Satisfaction
Timepoint
6 hours after delivery
Method of measurement
McKay Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: From the beginning of the active phase of delivery until the end of the second stage of delivery in the intervention group, 4 ml of spring orange essential oil is poured on the absorbable handkerchief, smells and is the same size and is attached to the collar of their clothes with a pin.
Category
Treatment - Other
2
Description
Control group: From the beginning of the active phase of delivery until the end of the second stage of delivery in the intervention group, 4 ml of distilled water is poured on the non-absorbable, odorless and one-size-fits-all handkerchief and attached to the collar of their clothes with a pin Is replaced.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Behlool Gonabadi Hospital
Full name of responsible person
Narges Bahri
Street address
Imam Street, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 5027
Email
nargesbahri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Javad Bazeli
Street address
Imam Street, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 5027
Email
Riasat@gmu.ac.ir
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
Narjes Bahri
Position
Associate Professor of Gonabad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Imam Street, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 5027
Email
nargesbahri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Narjes Bahri
Position
Associate Professor of Gonabad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Imam Street, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
397
Phone
+98 51 5722 5027
Email
nargesbahri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Narjes Bahri
Position
Associate Professor of Gonabad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Imam Street, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 5027
Email
nargesbahri@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD