This study is a randomized single blind clinical trial carried out in order to estimate the effect of breath technique and aromatherapy by essence of lavender on labor pain in an educational hospital of Shahrood. Subjects were primiparous pregnant women, without acute or chronic disease or allergy with singleton fetus and candidate for vaginal delivery. 240 women (60 in each group) were allocated into 4 groups based on blocks randomization method: breathe technique with essence of lavender conducted by nebulizer, only breath technique, essence of lavender conducted by nebulizer, water conducted by nebulizer for control group of Lavender. Breathing technique was educated to women before starting active phase (4 centimeters dilatation). Lavender 1.5% and usual water were used. Pain was measured by visual analog scale in dilatations 4-6, 6-8 and 8-10 centimeter, one time in each dilatation category. Participants were excluded if they showed allergy to Lavender or were candidate of caesarean section.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138804031557N2
Registration date:2009-07-21, 1388/04/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-07-21, 1388/04/30
Registrant information
Name
Katayon Vakilian
Name of organization / entity
Arak University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3502
Email address
k_vakili@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrood University of Medical Sciences and Health Services
Expected recruitment start date
2009-01-30, 1387/11/11
Expected recruitment end date
2010-01-30, 1388/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of breath technique and aromatherapy by essence of Lavender on labor pain
Public title
The effect of breath technique and aromatherapy by essence of Lavender on labor pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Primiparous pregnancy, lack of, allergy, singelton fetus, candidate for vaginal delivery
Exclusion Criteria: Any acute or chronic disease, hypersensitivity to Lavender, candidate for caesarean section due to maternal and fetal indication
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrood University of Medical Sciences and Health Services
Street address
Shahrood University of Medical Sciences and Health Services
City
Shahrood
Postal code
Approval date
empty
Ethics committee reference number
8702
Health conditions studied
1
Description of health condition studied
labor pain
ICD-10 code
O75.0
ICD-10 code description
Maternal distress during labour and delivery
Primary outcomes
1
Description
pain
Timepoint
during cervix dilatations of 4-6, 6-8 ,8-10 centimeter, one time in each period
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Duration of the first phase of labor
Timepoint
From hospitalization to full dilatation
Method of measurement
labor time in hour
Intervention groups
1
Description
essential oil of lavender(1.5%) with breath technique via nebulizer during conteractions active phase labor
Category
Treatment - Drugs
2
Description
breath technique group during conteractions active phase labor
Category
Treatment - Devices
3
Description
Essential oil of Lavender via nebulizer during contractions of active phase labor
Category
Treatment - Drugs
4
Description
water via nebulizer during contractions of active phase labor
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital, Shahrood University of Medical Sciences and Health Services
Full name of responsible person
Street address
Shahrood University of Medical Sciences and Health Services, Hafte tir Square,
City
Shahrood
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrood University of Medical Sciences and Health Services
Full name of responsible person
Katayon Vakilian
Street address
Shahrood University of Medical Sciences and Health Services, Hafte tir Square
City
Shahrood
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrood University of Medical Sciences and Health Services
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
Shahrood University of Medical Sciences and Health Services
Full name of responsible person
Katayon Vakilian
Position
Faculty member/ Midwifery Msc
Other areas of specialty/work
Street address
Shahrood University of Medical Sciences and Health Services, Hafte tir Square
City
Shahrood
Postal code
Phone
+98 21 2285 3567
Fax
Email
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mesical Science and Health Servise of Shahrood University
Full name of responsible person
Katayon Vakilian
Position
Faculty member / Midwifery Msc
Other areas of specialty/work
Street address
Hafte tir Squer -Mesical Science and Health shahrood University
City
Shahrood
Postal code
Phone
+98 21 2285 3567
Fax
Email
k_vakili@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrood University of Medical Sciences and Health Services
Full name of responsible person
Katayon Vakilian
Position
Faculty member/ midwifery Msc/ Ph.D student in reproductive health
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)