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The effect of lavender essential oil and olive oil on perineal care after delivery

Protocol summary

Summary
In this double blind randomized trial, the effect of lavender essential oil (lavandulla officinallis) and olive oil will be evaluated to treat perineal tear after delivery. Inclusion criteria: NVD without instrument and perineal tear (mediolateral episiotomy, 1 & 2 degree perineal rupture). Exclusion criteria: diabetes, kidney diseases, severe anemia (Hb<9 mg/dl in admission time), 3 & 4 degree perineal rupture. Ninety females will be selected after NVD and will be put in three groups: lavender essential oil based on olive oil, olive oil and placebo (normal saline). After educating health tips to women, we will educate them to use 10 drops of drug in 5 liters warm water as sitz bath during 15 minutes 2 times per day. Also, the researcher will evaluate perineal pain severity with VAS (Visual Analog Scale) scale and tear improvement sign with REEDA (redness, edema, Ecchymosis, discharge, approximation) scale in three groups 2 hours and 5 & 10 days after delivery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138902083004N2
Registration date: 2010-05-21, 1389/02/31
Registration timing: prospective

Last update:
Update count: 0
Registration date
2010-05-21, 1389/02/31
Registrant information
Name
Fereshteh Behmanesh
Name of organization / entity
Babol university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1322 5585
Email address
midwifery@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol univercity of medical sceinces
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2010-09-23, 1389/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender essential oil and olive oil on perineal care after delivery
Public title
Evaluation the effect of lavender essential oil and olive oil on perineal care after delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: NVD without instrument and perineal tear (mediolateral episiotomy, perineal 1 & 2 degree rupture). Exclusion criteria: acute or chronic disease such as diabetes, kidney diseases, severe anemia (Hb<9 mg/dl in admission time), history of allergy and perineal 3 & 4 degree rupture.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Babol univercity of medical sceinces
Street address
Babol univercity of medical sceinces
City
Babol
Postal code
Approval date
2010-02-16, 1388/11/27
Ethics committee reference number
5795

Health conditions studied

1

Description of health condition studied
Perineal care after delivery
ICD-10 code
090.1
ICD-10 code description
Disruption of perineal wound

Primary outcomes

1

Description
repair of perineal tear
Timepoint
5 days
Method of measurement
REEDA scale

Secondary outcomes

1

Description
perineal tear pain
Timepoint
5 days
Method of measurement
VAS scale

Intervention groups

1

Description
First group: sitz bath with 4 litr warm water and 10 drops lavender essensial oil1/5% based with olive oil
Category
Treatment - Drugs

2

Description
Third group: sitz bath with 4 litr warm water and 10 drops normal saline
Category
Placebo

3

Description
Second group: sitz bath with 4 litr warm water and 10 drops olive oil
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers of Babol university of medical sciences
Full name of responsible person
Fereshteh Behmanesh
Street address
Babol university of medical sciences
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol university of medical sciences
Full name of responsible person
Amrollah Mostafazadeh
Street address
Vice chancellor for research, Babol university of medical sciences
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol university of medical sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Midwifery msc/faculty member
Other areas of specialty/work
Street address
Midwifery group, Babol university of medical sciences
City
Babol
Postal code
Phone
+98 11 1219 0597
Fax
Email
f24farzan45@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol university of medical sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Midwifery msc
Other areas of specialty/work
Street address
Babol university of medical sciences midwifery group
City
Babol
Postal code
Phone
+98 11 1219 0597
Fax
Email
f24farzan45@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol university of medical sciences
Full name of responsible person
Dr Mahtab Zeinalzadeh
Position
Obstetric & Gynecologist/faculty member
Other areas of specialty/work
Street address
Babol university of medical sciences
City
Babol
Postal code
Phone
+98 111219935
Fax
Email
ZEINALMAHTAB@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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