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Comparison of aromatherapy with lavender and Nitrous oxide on labor pain

Protocol summary

Study aim
Comparison of the effect of aromatherapy with lavender and nitrous oxide on labor pain
Design
A clinical trial with a community-based control and control group, a blind, randomized, randomized clinical trial
Settings and conduct
Imam Khomeini Hospital of Shirvan Examples are blind to the study.
Participants/Inclusion and exclusion criteria
Age, gestational age, diploma literacy, single pregnancy, 4 cm dilatation, low risk pregnancy, informed consent and lack of: premature delivery, bleeding, pre-eclampsia, diabetes, seizure, history of acute and chronic pain, professional exercise, alcohol and cigarette addiction, receipt of pain medication, history of allergy to herbal, fetal distress, clear stenosis in the pelvic floor, known psychological disease and being in the active phase of labor
Intervention groups
In the aromatherapy group with lavender essential oil, mothers are required to smoke during cold shrinkage during shrinkage and pain. The use of nitrous oxide in the group begins with the onset of the active phase of labor.
Main outcome variables
Change in labor pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180610040032N1
Registration date: 2018-10-22, 1397/07/30
Registration timing: registered_while_recruiting

Last update: 2018-10-22, 1397/07/30
Update count: 0
Registration date
2018-10-22, 1397/07/30
Registrant information
Name
Mohammad Zarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3622 5602
Email address
m.zarei@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of aromatherapy with lavender and Nitrous oxide on labor pain
Public title
Comparison the effect of lavender and Nitrous oxide on labor pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age Between 37 and 42 weeks At least Diploma Literacy Singleton pregnancy 4 cm dilatation Low risk pregnancy (no rupture over 6 hours of water sac) Conscious consent of the individual to enter the study
Exclusion criteria:
Preterm delivery Third-trimester hemorrhage and intrauterine growth retardation Preeclampsia 24<BMI<18.5 History of acute and chronic pain such as migraine Performing professional exercise (due to changes in the threshold of pain and delivery phase) Drug Addiction, Alcohol and Smoking Receive analgesic within 3 hours before the onset of intervention History of allergy to herbal Diseases of internal and surgical diseases in mother and fetus Existence of fetal distress symptoms Clear stenosis in the pelvic floor Known mental disease Stay in active phase of labor Diabetes Seizure
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are randomly assigned to two groups of aromatherapy with lavender and nitrous oxide gas.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, the subjects will not be aware of the type of intervention they will receive.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of North Khorasan University of Medical Sciences
Street address
Dolat Ave.
City
Bojnurd
Province
North Khorasan
Postal code
9414975516
Approval date
2018-07-24, 1397/05/02
Ethics committee reference number
IR.NKUMS.REC.1397.031

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified

Primary outcomes

1

Description
Change in pain
Timepoint
Before the beginning of the study, at dilates 6-4, 8-6, 10-8 cm and immediately after intervention
Method of measurement
VAS

Secondary outcomes

1

Description
Satisfaction Survey
Timepoint
End of research
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: In the lavender aromatherapy group, the essential oil produced by Barij Essen was used in the stoechas species, which is distilled with a concentration of 1.5% of the unopened flowers, and is given to mothers by means of masked cold-smoked incense. Mothers are asked to smoke during a contraction and pain through a cold-smoked mask.
Category
Treatment - Drugs

2

Description
Control group: In the Nitrosoxide group, training on the use of masks and how to breathe during use in women is given, and starting with the onset of active phase of labor, nitrous oxide gas begins. Mothers inhale the gas at the onset of the pain and stop the inhalation with the end of the pain and this procedure continues until the end of the second phase of labor.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeyni hospital
Full name of responsible person
Salimeh Azizi
Street address
Imam Reza, Shirvan
City
Shirvan
Province
North Khorasan
Postal code
9461646974
Phone
+98 58 3622 5602
Email
azizi.s1990@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Seyed Kaveh Hojjat
Street address
Imam
City
Shirvan
Province
North Khorasan
Postal code
9471637557
Phone
+98 58 3622 5602
Email
m.zarei@nkums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Mohammad Zarei
Position
Educator
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam
City
Shirvan
Province
North Khorasan
Postal code
9471637557
Phone
+98 58 3622 5602
Email
m.zarei@nkums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Salimeh Azizi
Position
Educator
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam
City
Shirvan
Province
North Khorasan
Postal code
9471637557
Phone
+98 58 3622 5602
Email
azizi.s1990@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mohammad Zarei
Position
Educator
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam
City
Shirvan
Province
North Khorasan
Postal code
9471637557
Phone
+98 58 3622 5602
Email
m.zarei@nkums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Give raw data after removing sample instances
When the data will become available and for how long
At the request of the publication of the article
To whom data/document is available
Reviewers journals, planners and authors interested in writing meta-analysis articles
Under which criteria data/document could be used
Observing the rights of researchers
From where data/document is obtainable
Submit a written request to corresponding author
What processes are involved for a request to access data/document
Submit a written request to corresponding author
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