This clinical trial study will do to assess the effect of aromatherapy with rose water on pain and duration of the stages of labor in nulliparous women. Main inclusion criteria include normal range of estimated weight of neonate (2500-4000 gr) ؛cephalic presentation؛ gestational age of 37-40 weeks؛ single pregnancy؛ active phase of labor (dilation of 4 cm and uterine contraction for at least 30 seconds and 3 contractions in 10 minutes) and normal body mass index in the first trimester (19.8-26). Main exclusion criteria include receiving analgesic drugs during the 3 hours before the study and during the study؛ use of sedative and narcotic drugs and use of oxytocin for induction or augmentation of labor. In this study, 80 nulliparous women referred to Ahvaz Amir-al Moemenin hospital will select randomly based on table of random numbers and will divide to equal groups of intervention and control. In intervention group, aromatherapy with rose water will do during initiation of active phase of labor and initiation of second phase of labor. In control group, routine cares such as regular vaginal examination will do and women will sympathize. Pain severity will assess with visual analogue scale in 3 phases of dilatation: 4-6 cm, 6-8 cm and 8-10 cm in both groups. Also, duration of active phase of labor and second phase of labor will measure with chronometer in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102919744N1
Registration date:2015-10-31, 1394/08/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-31, 1394/08/09
Registrant information
Name
Shima Vahaby
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8331
Email address
s.vahaby@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahwaz Judishapur University of Medical Sciences
Expected recruitment start date
2015-01-05, 1393/10/15
Expected recruitment end date
2015-04-04, 1394/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of aromatherapy with rose water and routine cares on pain and duration of the stages of labor in nulliparous women
Public title
The effect of aromatherapy with rose water on pain and duration of the stages of labor in nulliparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Primiparous pregnancy؛ normal range of estimated weight of neonate (2500-4000 gr) ؛age of 18-35 years old؛ cephalic presentation؛ gestational age of 37-40 weeks؛ single pregnancy؛ active phase of labor (dilation of 4 cm and uterine contraction for at least 30 seconds and 3 contractions in 10 minutes)؛ low risk pregnancy؛ normal body mass index in the first trimester (19.8-26) ؛having at least read and write literacy.
Exclusion criteria: Being an athlete؛ having drug addiction؛ receiving analgesic drugs during the 3 hours before the study and during the study؛ use of sedative and narcotic drugs؛ history of infertility؛ history of eczema and allergies to plants؛ use of oxytocin for induction or augmentation of labor؛ narrow pelvis
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ahwaz Jundishapur University of Medical Sciences, Ahvaz, Khozestan
City
Ahvaz
Postal code
Approval date
2015-02-22, 1393/12/03
Ethics committee reference number
1393.325
Health conditions studied
1
Description of health condition studied
Pain and duration of labour
ICD-10 code
O60.2
ICD-10 code description
Preterm spontaneous labour with term delivery
Primary outcomes
1
Description
Pain severity
Timepoint
Arrival time of cervical dilation to 6-4 cm, 8-6 cm and 10-8 cm during labor
Method of measurement
Visual analogue scale
2
Description
Duration of labour
Timepoint
Every one to two hours
Method of measurement
Examination and recording in the examination form
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, aromatherapy with rose water will do during initiation of active phase of labor and initiation of second phase of labor
Category
Treatment - Other
2
Description
In control group, routine cares such as regular vaginal examination will do and women will sympathize.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-al Moemenin hospital
Full name of responsible person
Shima Vahaby
Street address
Shahid Rajae area, Sepidar, Ahvaz, Khuzestan
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahwaz Judishapur University of Medical Sciences
Full name of responsible person
Dr. Ahmad Hosseini
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahwaz Judishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shima Vahaby
Position
Student
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan.
City
Ahvaz
Postal code
Phone
+98 61 3373 8331
Fax
Email
shvahaby@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Parvin Abedi
Position
P.H.D of Nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
Phone
+98 61 3373 8331
Fax
Email
Parvinabedi@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shima Vahaby
Position
Student
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
Phone
+98 61 3373 8331
Fax
Email
shvahaby@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)