Investigating the Effect of Aromatherapy on Pregnant mothers with Flavors of Citrus aurantium on the Apgar score of newborn infants during elective cesarean section surgery
Investigating the Effect of Aromatherapy on Pregnant mothers with Flowers of Citrus aurantium on the Apgar score of newborn infants during elective cesarean section surgery
Design
This is a double-blind randomized study. The study group consisted of 92 women referred to Jahrom Motahhari Hospital who underwent cesarean section.
Settings and conduct
The study will be carried out at Motahari Hospital in Jahrom. The person is asked to inhale essential oil for 30 minutes and this process will continue until entering the operating room. Then after the baby is born, Weight and apgar score will be recorded at one and five minutes after birth by a pre-trained researcher who has no knowledge of whether the patient and her infant are in the intervention or control group and Similarly, these steps perform using three drops of distilled water in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria included pregnant mothers' consent to participate in the study; 18-35 years of age; no sensitivity to spring orange; term pregnancy; no analgesic use in the past 8 hours and no respiratory disease.Exclusion criteria included patient dissatisfaction and respiratory problems during surgery.
Intervention groups
Half an hour before entering the operating room, the aromatherapy mixture containing 3 drops of 10% Citrus aurantium , prepared by Tebab Drug Company, is poured onto a cotton pad and we ask the person to breathe for 10 minutes from a distance of 10 cm(the essential oil cotton is attached to the collar of patients' operating room 10 cm from the nose) and this process will continue until entering the operating room. Then after the baby is born, her/his apgar score will be measured by the researcher at one and five minutes after birth.
Main outcome variables
Apgar score in infants one and five minutes after birth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130718014049N10
Registration date:2020-04-12, 1399/01/24
Registration timing:registered_while_recruiting
Last update:2020-04-12, 1399/01/24
Update count:0
Registration date
2020-04-12, 1399/01/24
Registrant information
Name
Ali Abbasi Jahromi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 79 1334 1501
Email address
abbasija@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-29, 1399/01/10
Expected recruitment end date
2020-06-30, 1399/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Aromatherapy on Pregnant mothers with Flavors of Citrus aurantium on the Apgar score of newborn infants during elective cesarean section surgery
Public title
The effect of aromatherapy in women undergoing cesarean section with spinal anesthesia on neonatal apgar score
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients undergoing cesarean section at Motahari Hospital of Jahrom University of Medical Sciences.
Spinal anesthesia for the mother has been approved by the anesthesiologist.
Term pregnancy
Patient Satisfaction to Participate in the Study and No Sensitivity to Citrus aurantium
Term pregnancy
Non-emergency surgery
Exclusion criteria:
Respiratory Disease
Pain medication for the past 8 hours
Incidence of labor complications such as vaginal bleeding during research
Addiction and psychotropic drugs
The patient and his wife declare their consent to continue the study
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the subjects, the dice will be divided into two groups: intervention and control.In this way, once a dice is thrown for each patient, the patient with will be in the even number will be in intervention group, and patient with odd number will be in the control group.In addition the person evaluating the consequence is unaware of the manner and results of this accident.
Blinding (investigator's opinion)
Double blinded
Blinding description
A double blind method was used for blinding in this study so that 1- volunteer 2- Neonatal Apgar Scale Measurer does not know about intervention and control groups.Both intervention and control groups will be told that drops of liquid will be poured onto the cotton and you will be asked to breathe in with normal breathing;So they won't know the type of drop.Due to the fact that the patient of the intervention group did not know the type of substance used in the patient, the control group (distilled water) and while our dependent variable is measured from the newborn؛Therefore, the mother and baby do not know their intervention group؛So if the mother's condition affects the dependent variable, which is measured from the baby, the mother still has no knowledge of her intervention or control group.،Because it does not know the type of material used in the control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Jahrom University of Medical Sciences
Street address
Ethic committee, Jahrom University of medical science, martyr Motaharie Blvd, Jahrom
City
Jahrom
Province
Fars
Postal code
4619974148
Approval date
2020-02-25, 1398/12/06
Ethics committee reference number
IR.JUMS.REC.1398.096
Health conditions studied
1
Description of health condition studied
Apgar score scale after maternal aromatherapy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Apgar score
Timepoint
The first minute after birth
Method of measurement
Based on Apgar Scale
2
Description
Apgar score
Timepoint
Fifth minute after birth
Method of measurement
Based on Apgar Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Half an hour before entering the operating room, 3 drops of distilled water are poured on a cotton pad and we ask the person to breathe for 10 minutes from a distance of 10 cm (cotton soaked in distilled water). It is attached to the collar of the patient's operating room collar (10 cm from the nose) and will continue until the operating room arrives. Then after the baby is born, Weight and apgar score will be recorded at one and five minutes after birth by a pre-trained researcher who has no knowledge of whether the patient and her infant are in the intervention or control group.
Category
N/A
2
Description
Intervention group: Half an hour before entering the operating room, the aromatherapy mixture containing 3 drops of 10% Citrus aurantium , prepared by Tebab Drug Company, is poured onto a cotton pad and the person is asked to rest for 30 minutes on a regular basis. Breathe in with a normal breath of 10 cm (the essential oil cotton is attached to the collar of patients' operating room 10 cm from the nose) and this process will continue until entering the operating room. Then after the baby is born, Weight and apgar score will be recorded at one and five minutes after birth by a pre-trained researcher who has no knowledge of whether the patient and her infant are in the intervention or control group.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Martyr Motaharie hospital
Full name of responsible person
ali reza momtahan
Street address
Master Motaharie Blvd, Jahrom
City
jahrom
Province
Fars
Postal code
74157-13597
Phone
+98 71 5433 3001
Email
alireza.momtahan4044@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Kavoos Solh joo
Street address
Research deputy, Jahrom University of medical science, martyr Motaharie Blvd, Jahrom
City
jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0406
Email
alireza.momtahan4044@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
En Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Ali Abasi Jahromi
Position
Science Committee
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Research deputy, Jahrom University of Medical science, martyr Motaharie Blvd, Jahrom
City
jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0406
Email
aliabbasijahromi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Ali Abasi Jahromi
Position
Science Committee
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Research deputy, Jahrom University of medical science, martyr Motaharie Blvd, Jahrom
City
jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0406
Email
aliabbasijahromi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
ali reza momtahan
Position
Collegian
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Research deputy, Jahrom University of medical science, martyr Motaharie Blvd, Jahrom
City
jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0406
Email
alireza.momtahan4044@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
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
IPD collected for the primary outcome measure only
When the data will become available and for how long
Six months after the results were published
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
Only scientific and practical use is permitted
From where data/document is obtainable
Jahrom university of medical sciences
What processes are involved for a request to access data/document