The purpose of this research was to investigate the effect of Massage Aromatherapy with lavandula the duration of first and second stage of labor in nulliparous women. design:randomized, single blind,control with placebo,single center,Phase one trial Method:a)population:Term pregnant women who admitted to mahdieh hospital in tehran city in 2008 that referred to vaginal delivery.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.3)Sample size:90 people.b) Intervention:Ninety women divided into three groups.First group took only massage.Second group took massage with Almond oil,and third group took massage aromatherapy with Lavender oil.Each group received back effleurage massage. c)Intervention of Time: Massage Was performed during the three stages, dilatation (4-5 and 6-7 and 8-10) for 20 minutes.Primary outcome measure:Lenght of active phase and second stage of labor.Secondary outcome measure:pain intensity of active phase on labor and Satisfaction of intervention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209107727N2
Registration date:2012-09-22, 1391/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-22, 1391/07/01
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 Aromatherapy with lavandula on Decrease Lenght of First And Second Stage of Labor In Nulliparous Women
Public title
Effect of Lavender on Duration Of Labor
Purpose
Prevention
Inclusion/Exclusion criteria
The main criteria for inclusion to study: signing informed consent; age between 18-35 years old; gestational age between 37-42 weeks; 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
Lenght of Second Stage of Labor
ICD-10 code
O63.1
ICD-10 code description
Prolonged Second Stage (of labour)
2
Description of health condition studied
Lenght of Active Phase of Labor
ICD-10 code
063.0
ICD-10 code description
Prolonged First Stage (of labour)
3
Description of health condition studied
Pain of Labor
ICD-10 code
075/9
ICD-10 code description
Complication Of Labour And Delivery,Unspecified
Primary outcomes
1
Description
Lenght of Active Phase of Labor
Timepoint
From 4 cm dilatation to 10 cm dilatation
Method of measurement
By Citizen timer
2
Description
Lenght of Second Stage Of Labor
Timepoint
From 10 cm dilatation to delivery
Method of measurement
By Citizen timer
Secondary outcomes
1
Description
Pain Intensitye of Labor
Timepoint
Before and after the 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
2
Description
Satisfaction of intervention
Timepoint
About 1 to 2 hours after delivery, the parturient was prepared, by the help of a researcher is completed.
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 Mohammadkhani Shahri
Street address
Fadaeyan Eslam Aven - Shush Square
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 University Karaj Branch
Full name of responsible person
Leila Mohammadkhani Shahri
Position
Instructor Of Midwifery - Midwifery Of Ms Degree
Other areas of specialty/work
Street address
Nursing And Midwifery College- On The Corner Of Esteghlal And Shahid Moazen Blvd, End Of Rajaee Shahr
City
Karaj
Postal code
313 - 31485
Phone
+98 26 3440 3251
Fax
Email
support@kiau.ac.ir
Web page address
http://www.kiau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Karaj Branch
Full name of responsible person
Leila Mohammadkhani Shahri
Position
Instructor Of Midwifery - Midwifery Of Ms Degree
Other areas of specialty/work
Street address
Nursing And Midwifery College- On The Corner Of Esteghlal And Shahid Moazen Blvd, End Of Rajaee Shahr
City
Karaj
Postal code
Phone
+98 26 3440 3251
Fax
Email
info@kiau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Karaj Branch
Full name of responsible person
Leila Mohammadkhani Shahri
Position
Instructor Of Midwifery- Midwifery Of Ms Degree
Other areas of specialty/work
Street address
Nursing and Midwifery College- on the corner of Esteghlal And Shahid Moazen Blvd, End Of Rajaee Shahr
City
Karaj
Postal code
Phone
+98 26 3440 3251
Fax
Email
info@kiau.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)