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Evaluation of the effect of aromatherapy with Narcissus Essence oil on labor pain in nulliparous women

Protocol summary

Study aim
Determining the effect of aromatherapy with Narcissus essential oil on labor pain in nulliparous women
Design
Clinical randomized control trial with control group, parallel groups, without blinding, 80 participants
Settings and conduct
The study population consisted of 80 nulliparous women referred to Farideh Behbahani Obstetrics and Gynecology Hospital in Behbahan. pain intensity is taught to people using the visual pain scale. In dilatation 4 cm before the intervention, pain intensity is measured. For the intervention group, during the active phase of labor, 3 cc of narcissus essential oil is continuously poured into 100 cc of headquarters water and dispersed in the space . After intervening in dilatation of 6, 8 and 10 cm, the intensity of pain is determined by the client on the pain ruler. For the control group, routine procedures are performed and pain intensity is measured in 6, 8 and 10 cm dilatation.
Participants/Inclusion and exclusion criteria
Age 18-35 years, single pregnancy, cephalic presentation, gestational age 37-41 weeks, low risk pregnancy, dilatation 4 cm, no narcotics, fetal developmental disorders, infertility history, smell problems, allergy to plants
Intervention groups
Pain intensity is taught to people using the visual pain scale. In dilatation 4 cm before the intervention, pain intensity is measured. For the intervention group, during the active phase of labor, 3 cc of narcissus essential oil is continuously poured into 100 cc of headquarters water and dispersed in the space. After intervening in dilatation of 6, 8 and 10 cm, the intensity of pain is determined by the client on the pain ruler. For the control group, routine procedures are performed and pain intensity is measured in 6, 8 and 10 cm dilatation.
Main outcome variables
Pain intensity, length of active phase of labor, length of second phase of labor

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200928048863N1
Registration date: 2021-03-21, 1400/01/01
Registration timing: registered_while_recruiting

Last update: 2021-03-21, 1400/01/01
Update count: 0
Registration date
2021-03-21, 1400/01/01
Registrant information
Name
ّFatemeh Tanoureh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5280 2748
Email address
fatemehtanoureh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-28, 1399/12/10
Expected recruitment end date
2021-08-01, 1400/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of aromatherapy with Narcissus Essence oil on labor pain in nulliparous women
Public title
Effect of aromatherapy with Narcissus Essence oil on labor pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single pregnancy Cephalic Presentation Gestational age 37-41 weeks Dilatation 4 cm Low risk pregnancy Literacy for reading and writing Live fetus without anomaly Do not take narcotics
Exclusion criteria:
Cephalopelvic disorders Fetal developmental disorders Drug addiction History of infertility Smell problems Sensitivity to plants Maternal medical disease
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals with inclusion criteria are divided into two groups of control and intervention by double blocking method. For random allocation, two envelopes A and B are used. The control and intervention group is placed in each envelope by a second person who does not know the subject of the research and is closed. One envelope is selected every day and on that day two qualified people The conditions are assigned to the selected group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
No. 11, Shahid Safari Alley; Hojjat Alley
City
Behbahan
Province
Khouzestan
Postal code
6361743345
Approval date
2021-01-24, 1399/11/05
Ethics committee reference number
IR.AJUMS.REC.1399.829

Health conditions studied

1

Description of health condition studied
Labor pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
labor pain
Timepoint
In dilatation 4 cm (before intervention) in dilatation 6, 8 and 10 (after intervention)
Method of measurement
Vas questionnaire

Secondary outcomes

1

Description
Dose not have
Timepoint
Dose not have
Method of measurement
Dose not have

Intervention groups

1

Description
Intervention group: In dilatation of 6, 8 and 10, 3 cc of narcissus essential oil in 100 cc of distilled water is poured into the incense burner and participants are asked to take deep breaths with each contraction. Then the severity of the pain is measured.
Category
Treatment - Other

2

Description
Control group: In dilatation of 6, 8 and 10 cm, pain intensity in participants is measured.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farideh Behbahani Hospital
Full name of responsible person
Fatemeh Tanoureh
Street address
No. 11, Shahid Safari Alley; Hojjat Alley
City
Behbahan
Province
Khouzestan
Postal code
6361743345
Phone
+98 61 5280 2748
Email
fatemehtanoureh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
No. 11, Shahid Safari Alley; Hojjat Alley
City
Behbahan
Province
Khouzestan
Postal code
6361743345
Phone
+98 61 5280 2748
Email
fatemehtanoureh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Parvaneh Mousavi
Position
supervisor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 11, Shahid Safari Alley; Hojjat Alley
City
Behbahan
Province
Khouzestan
Postal code
6361743345
Phone
+98 61 5280 2748
Email
mousavip2009@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
parvaneh Mousavi
Position
supervisor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 11, Shahid Safari Alley; Hojjat Alley
City
Behbahan
Province
Khouzestan
Postal code
6361743345
Phone
+98 61 5280 2748
Email
mosavip2009@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parvaneh Mousavi
Position
Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 11, Shahid Safari Alley; Hojjat Alley
City
Behbahan
Province
Khouzestan
Postal code
6361743345
Phone
+98 61 5280 2748
Email
mousavip2009@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 more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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