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Comparison the efficacy of lavender aroma and valerian in reducing labor pain and Progress of labor in nulliparous women

Protocol summary

Summary
The aim of this double blind randomized trial, is evaluation of the effects of Lavender aroma and Valerian in reducing labor pain and progress of labor in nulliparous women in Hazrate Fateme hospital in Miandoab. Enrolled mothers will be randomly allocated into 3 groups (Lavender, Valerian or placebo) using block randomization method. Lavender, Valerian and a placebo oils with similar glasses and appearance will be prepared by Bareej Essence Pharmacotical Company. The aromatic substance will be impregnated by the researcher assistant and the packets will be prepared. Participants will enter to the study in order number written on each envelope. Labor pain intensity will be evaluated using Visual Analogue Scale when cervix dilatation is 4 cm in 3 groups. Then researcher opens the corresponding subject envelope and places drops from Glass labeled 1, 2 or 3 on a cotton ball and the patient will smell it for 10 minutes every one hour. The amniotic fluid, duration of rupture of membranes, liquid paints, fetal heart rate, medications, cervical dilatation and fetal descent rate, number and duration of contractions, the baby's Apgar score at one and five minutes of observation and examination will be recorded. The Pain also will be measured by Visual Analog Scale in dilatations 6, 8, 9 and 10 centimeter.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201504236582N10
Registration date: 2015-05-30, 1394/03/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-05-30, 1394/03/09
Registrant information
Name
Mahin Kamalifard
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 414796770
Email address
kamalifardm@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of lavender aroma and valerian in reducing labor pain and Progress of labor in nulliparous women
Public title
Comparison the efficacy of lavender aroma and valerian in reducing labor pain and Progress of labor in nulliparous women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Primiparous pregnancy; age 18-35; gestational age of 37-41 w; singleton fetus; active phase; cephalic presentation; no smoking; no addiction; no Lack of vision; no history of chronic heart diseases, lung diseases, according to the patient's expression; the absence of eclampsia; and placenta previa; no PROM for more than 18 hours; no history of infertility; willingness to participate in the study; no history of sensitivity; the presence of low-risk pregnancies. Exclusion Criteria: Get analgesic medication during the 3 hours before the start of the study; systolic blood pressure less than 95 mm Hg.
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: 141
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Central Building No. 2, Research Administration,Tabriz University of Medical Sciences, Daneshgah st.
City
Tabriz
Postal code
Approval date
2015-03-09, 1393/12/18
Ethics committee reference number
93192

Health conditions studied

1

Description of health condition studied
Labor pain
ICD-10 code
O83.8
ICD-10 code description
Other specified assisted single delivery

Primary outcomes

1

Description
intensity of labor pain
Timepoint
before intervention, 6-8-10cm of cervix dilatasion
Method of measurement
VAS (Visual Analog Scale)

Secondary outcomes

1

Description
The duration of the active phase
Timepoint
each 2 hour
Method of measurement
vaginal examination

2

Description
Duration of the second stage of labor
Timepoint
from full dilatasion until lTime of Birth
Method of measurement
Questionnaire

3

Description
Neonatal outcomes (The first and fifth minute Apgar scores and Refer to the NICU)
Timepoint
After birth
Method of measurement
Questionnaire

4

Description
Type of delivery
Timepoint
After birth
Method of measurement
Questionnaire

5

Description
Side effects (Nausea and vomiting)
Timepoint
During the study
Method of measurement
cheklist

Intervention groups

1

Description
In Lavender group in dilatations 4 ;every hour, 3 drops of lavender aroma (Glass labeled 1) Drops on a cotton ball and the patient will be close to their nose and smell it for 10 minutes.
Category
Treatment - Drugs

2

Description
In valerian group in dilatations 4 cm; every hour, 3 drops of valerian aroma (Glass labeled 2) Drops on a cotton ball and the patient will be close to their nose and smell it for 10 minutes of every hour.
Category
Treatment - Drugs

3

Description
In Olive oil group in dilatations 4; every hour, 3 drops of Olive oil aroma (Glass labeled 3) Drops on a cotton ball and the patient will be close to their nose and smell it for 10 minutes.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Fatemeh Hospital
Full name of responsible person
Rana Dosty
Street address
Hazrat Fatemeh Hospital,Saheli St, Miandoab, East Azarbayjan.
City
Miandoab

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Street address
Nursing and Midwifery, South Shariati Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
Senior lecturer, Academician
Other areas of specialty/work
Street address
Nursing & Midwifery faculty of Tabriz Medical scienses
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
kamalifardm@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
Master Sciences of Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 914 314 6763
Fax
Email
kamalifard@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
Academic member,MS
Other areas of specialty/work
Street address
Nursing and Midwifery, Tabriz University of Medical Sciences, Shariaty st
City
tabriz
Postal code
Phone
+98 914 314 6763
Fax
Email
kamalifard@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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