Comparison of the effects of aromatherapy with Salvia officinal, Jasmine officinal and distilled water on pain severity and delivery out comev in nulliparous women referred to Shooshtary hospital in Shiraz 1388
The aim of this study was to investigate the effect of herbal therapy on pain severity of delivery. The participants in this study were 156 primiparous pregnant women with gestational age more than 37 weeks having single fetus with vertex position and were not candidate for elective caesarean section. The participants were randomly assigned into the following three groups to receive salvia officinal aroma, jasmine officinal aroma, or evaporation of distilled water for 15 minutes during active phase of delivery. Pain intensity, fetal heart rate, Apgar score, method of delivery, and duration of first and second stages of labor were compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811192515N1
Registration date:2011-01-13, 1389/10/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-13, 1389/10/23
Registrant information
Name
Maasumeh Kaviani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4251
Email address
kavianm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2009-11-22, 1388/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of aromatherapy with Salvia officinal, Jasmine officinal and distilled water on pain severity and delivery out comev in nulliparous women referred to Shooshtary hospital in Shiraz 1388
Public title
Comparison of the effects of aromatherapy with Salvia officinal and Jasmine officina on pain severity in nulliparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: primiparous, gestational age more than 37 weeks, vertex position, no candidate for elective caesarean section, single fetus, dilatation 3-4 cm, signing the informed consent
Exclusion criteria: bleeding, fetal distress, respiratory allergy, tetanic contraction during the intervention
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
156
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Next to Red Crescent center, Zand St., Shiraz
City
Shiraz
Postal code
71345-1978
Approval date
2009-06-22, 1388/04/01
Ethics committee reference number
CT-88-4712
Health conditions studied
1
Description of health condition studied
Aromatherapy effect on delivery pain
ICD-10 code
E084, E080
ICD-10 code description
single spontaneous delivery
Primary outcomes
1
Description
severity of pain
Timepoint
severity of pain before intervention, 30 and 60 minutes after intervention .
Method of measurement
by visual analog scale
2
Description
duration of first and secound stages of delivery
Timepoint
after delivery
Method of measurement
in minutes
3
Description
FHR
Timepoint
before intervention, 30 and 60 minutes after intervention
Method of measurement
Fetal heart rate by fetoscope
4
Description
method of delivery
Timepoint
After delivery
Method of measurement
Rate of different delivery methods
5
Description
Apgar score
Timepoint
before intervention, 30 and 60 after intervention
Method of measurement
Apgar scale
Secondary outcomes
empty
Intervention groups
1
Description
3 cc Jasmine essence with 50 cc distilled water evaporation during 15 minutes
Category
Treatment - Drugs
2
Description
3cc Salvia officinal essence with 50cc distilled water evaporation during 15 minutes.
Category
Treatment - Drugs
3
Description
50cc distilled water evaporation for 15 minutes
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shoshtary hospital of Shiraz
Full name of responsible person
Ms Asefy
Street address
Shiraz, Bascol nader st
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mostafavy
Street address
Next to Red Crescent center, Zand St., Shiraz
City
Shiraz
Grant name
88/54869
Grant code / Reference number
4712
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and midwifery faculty, Shiraz University of Medical Sciences
Full name of responsible person
Masoume Kaviani
Position
Midwife (master degree)
Other areas of specialty/work
Street address
Nursing and midwifery faculty
City
Shiraz
Postal code
71345-1978
Phone
+98 71 1647 4254
Fax
+98 71 1627 9135
Email
kanianm@sums.ir
Web page address
www.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery faculty, Shiraz University of Medical Sciences
Full name of responsible person
Masoume Kaviani
Position
Midwife (master degree), Instructor
Other areas of specialty/work
Street address
Namazi Sq., Shiraz
City
Shiraz
Postal code
71345-1978
Phone
+98 71 1647 4254
Fax
+98 71 1627 9135
Email
kavianm.sums.ac.ir
Web page address
www.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)