The objective of this study was to compare routine wound care with Povidone Iodine with using Lavender essential oil in episiotomy. 120 primiparous mothers with singleton pregnancy for whom episiotomy had been done after uncomplicated normal vaginal delivery were randomly allocated into either intervention or control group. Subjects with any acute or chronic systemic diseases, hypersensitivity, severe wound infection at fifth day after delivery or allergy to lavender derivatives were excluded. Intervention under study was using Lavender essential oil (5-7 drops in 4 liter water two times per day) as sit bath. Patients in control group received routine episiotomy wound care with Povidone Iodine. Main outcome measures were pain on wound site, wound site edema, wound infection, suppurative secretion, number of remained sutures at tenth day, and wound dehiscence.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138710281557N1
Registration date:2009-05-16, 1388/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-05-16, 1388/02/26
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
Arak University of Medical Science and Health Services and Barij Essence Pharmacology Company
Expected recruitment start date
2007-06-08, 1386/03/18
Expected recruitment end date
2007-09-21, 1386/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of Lavender essencial of oil and Povidon Iodine in wound healing of episiotomy
Public title
Comparison of effect of Lavender essencial oil and Povidon Iodine in wound healing of episiotomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : singleton pregnancy, primiparous, episiotomy
Exclusion criteria : severe infection in 5th day after episiotomy, any acute or chronic diseases or allergy to Lavender oil
Age
From 15 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Arak University of Medical Sciences and Health Services
Street address
Alamolhoda St.
City
Arak
Postal code
Approval date
2007-04-08, 1386/01/19
Ethics committee reference number
227
Health conditions studied
1
Description of health condition studied
Disruption of perineal obstetric wound
ICD-10 code
O90.1
ICD-10 code description
Disruption of perineal obstetric wound. episiotomy
Primary outcomes
1
Description
Edema
Timepoint
5 and 10 days after repair
Method of measurement
Diameter of edema on wound site in Centimiter
2
Description
Remaied sutures
Timepoint
10th day after repair
Method of measurement
number of remained sutures
3
Description
Pain
Timepoint
5th and 10th day after episiotomy
Method of measurement
visual analogue scale
4
Description
Redness
Timepoint
5 and 10 days after repair
Method of measurement
Diameter of redness in millimeter
5
Description
Discharge
Timepoint
5 and 10 after repair
Method of measurement
Presence of suppurative vaginal discharge
6
Description
Dehiscence
Timepoint
10th day after repair
Method of measurement
Incidence of wound dehiscence
Secondary outcomes
1
Description
Infection
Timepoint
5th and 10th day after child birth
Method of measurement
Presence of infective discharge and dehiscence of wound
Intervention groups
1
Description
Essential oil of Lavender 5-7 drops in 4 liter of water as sit bath two times a day for 2 weeks
Category
Prevention
2
Description
Povidon Iodine 4 spoon in 4 litter of water as sit bath for 2 weeks
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak University of Medical Sciences and Health Services
Full name of responsible person
Katayon Vakilian
Street address
Alamolhoda St.
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical sciences and Health Services
Full name of responsible person
Katayon Vakilian
Street address
Alamolhoda St.
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical sciences and Health Services
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Pharmacol Company of Barij Essence
Full name of responsible person
dr. Reza Bekhradi
Street address
Delijan, Pharmacol Company of Barij Essence
City
Delijan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmacol Company of Barij Essence
Proportion provided by this source
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
Arak University of Medical Sciences and Health Services
Full name of responsible person
Katayon Vakilian
Position
Master of Midwifery and Faculty Member
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Sardasht
City
Arak
Postal code
Phone
+98 912 324 9840
Fax
Email
k_vakili@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences and Health Services
Full name of responsible person
Katayon Vakilian
Position
Master of Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery Collage, Sardasht
City
Arak
Postal code
Phone
Fax
Email
k_vakili@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences and Health Services
Full name of responsible person
Katayon Vakilian
Position
Master of Midwifery and Faculty Member
Other areas of specialty/work
Street address
Arak University of Medical Sciences and Health Services, Alamolhoda St.
City
Arak
Postal code
Phone
+98 912 324 9840
Fax
Email
k_vakili@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)