Objective:The effect of massage aromatherapy with lavender oil on pain intensity of active phase of labor in nulliparous women.
Design:randomized, single blind, control with placebo, single center, Phase one trial
Method:
a)The study population:term pregnant women who admitted to Mahdiyeh Hospital in Tehran city in 2008 that referred to vaginal delivery .
1)The main criteria for inclusion to study: Private consent for the study; age between 18-35; gestational age between 37-42; cephalic presentation; singleton pregnancy ;cervical dilatation 4 cm; Iranian race; low-risk pregnancies; 19/8<BMI <26/4. 2)The main criteria for exclusion of study:athletes; addiction to narcotic; use of sedative drugs and also use of oxytocin as induction and agmentation.
3)Sample size:90 people
b )The study interventions:samples of eligible were divided into three groups as massage, massage with Almond oil, massage aromatherapy with lavender oil. Back massage was performed by effleurage.
c)The intervention of time:Massage was performed during 20 minutes in the three stages, dilatation 4-5 cm, dilatation 6-7 cm and dilatation 8-10 cm.
d)The primary outcome measure:Pain intensity of labor
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110057727N1
Registration date:2011-11-09, 1390/08/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-09, 1390/08/18
Registrant information
Name
Leila Mohammadkhani Shahri
Name of organization / entity
Islamic Azad University Karaj Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 7724 0711
Email address
l.mohamadkhani@gmail.com
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University Of Medical Sciences
Expected recruitment start date
2008-01-21, 1386/11/01
Expected recruitment end date
2008-06-20, 1387/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Massage Aromatherapywith Lavender Oil on pain intensity of active phase of labor in nulliparous women.
Public title
Effect of Lavender on pain of labor
Purpose
Prevention
Inclusion/Exclusion criteria
The main criteria for inclusion to study: signing informed consent; age between 18-35; gestational age between 37-42; cephalic presentation; singleton pregnancy; cervical dilatation 4 cm; Iranian race; low-risk pregnancies; 19 / 8< BMI <26 / 4.
The main criteria for exclusion of study:athletes; addiction to narcotic; use of sedative drugs and also use of oxytocin as induction and augmentation.
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:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University Of Medical Sciences
Street address
Deputy of Research and Technology, Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.- Ahvaz
City
Ahvaz
Postal code
61357-33184
Approval date
2008-01-15, 1386/10/25
Ethics committee reference number
7/8/پ/600
Health conditions studied
1
Description of health condition studied
Pain of labor
ICD-10 code
O75.9
ICD-10 code description
Complication of labour and delivery, unspecified
Primary outcomes
1
Description
Pain intensity of labor
Timepoint
Before and after of massage
Method of measurement
Visual analog scale pain in dilatation 5-4, 7-6 and 10-8 cm has been completed before and immediately after intervention (during contractions) between contractions by assistant in 6 times totally
Secondary outcomes
1
Description
Satisfaction of intervention
Timepoint
About 1 to 2 hours after delivery
Method of measurement
Satisfaction questionnaire
Intervention groups
1
Description
The intervention Group:The massage aromatherapy group with two drops of lavender oil solute in 50 cc bitter almond oil.
Kind of intervention group:drugs.
Efflorauge massage (rub) was performed gently and in medium press by rhythmic during three stages of dilatation 5-4 cm, dilatation 7-6 cm and dilatation 10-8 cm. These massages were performed in 20 minutes (during the intervals and between contractions).
The samples eligible have been massage at all of back in lateral position (semi-prone) and the assistant was standing or sitting.
Category
Treatment - Drugs
2
Description
The control group:The massage group without lavender oil.
Kind of control group:The previous executable program with mentioned specifications.
Efflorauge massage (rub) was performed gently and in medium press by rhythmic during three stages of dilatation 5-4 cm, dilatation 7-6 cm and dilatation 10-8 cm. These massages were performed in 20 minutes (during the intervals and between contractions).
The samples eligible have been massage at all of back in lateral position (semi-prone) and the assistant was standing or sitting.
Category
Treatment - Other
3
Description
The control group:The massage group with 15 cc of bitter almond oil .
Kind of control group: Placebo.
Efflorauge massage (rub) was performed gently and in medium press by rhythmic during three stages of dilatation 5-4 cm ,dilatation 7-6 cm and dilatation 10-8 cm. These massages were performed in 20 minutes (during the intervals and between contractions).
The samples eligible have been massage at all of back in lateral position (semi-prone) and the assistant was standing or sitting.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdiyeh Hospital
Full name of responsible person
Leila Mohamadkhani Shahri
Street address
Fadaeyan Eslam Ave., Shush Square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Abbaspoor
Street address
Unit 4, Deputy of Research and Technology,Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave., Ahvaz
City
Ahvaz
Grant name
--
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Islamic Azad Universuty Branch Of Birjand
Full name of responsible person
Samaneh Sabet Birgandi
Position
Master Of University, MS Degree Of Midwifery
Other areas of specialty/work
Street address
Ayatollah Ghaffari ave., Birjand
City
Birjand
Postal code
Phone
+98 56 1434 2260
Fax
+98 56 1434 2171
Email
Samane_Sabet5@yahoo.com
Web page address
www.Iaubir.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapure University Of Medical Sciences
Full name of responsible person
Zahre Abbaspoor
Position
Master Of University, MS Degree Of Midwifery
Other areas of specialty/work
Street address
Midwifery Group, Faculty Nursing And Midwifery, Ahvaz Jundishapure University Of Medical Sciences, Golestak Ave.
City
Ahvaz
Postal code
61357-33184
Phone
+98 61 1373 8331
Fax
+98 61 1336 1544
Email
Industry@ajums.ac.ir, Industry333@yahoo.com
Web page address
www.ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapure UniversityOf Medical Sciences
Full name of responsible person
Leila Mohamadkhani Shahri
Position
MS Degree of Midwifery, Instructor Of Midwifery
Other areas of specialty/work
Street address
Faculty Nursing And Midwifery, Ahvaz Jundishapure University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Postal code
61357-33184
Phone
+98 61 1373 8331
Fax
+98 61 1336 1544
Email
Industry@ajums.ac.ir, Industry333@yahoo.com
Web page address
www.ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)