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Comparison of topical effect of aloe vera gel and lavender essential oil in faster healing and reduction of episiotomy inflammation in patients referred to Hajar Hospital in Shahrekord

Protocol summary

Study aim
Comparison of topical effect of Aloe-vera gel and lavender essential oil in faster healing and reduction of episiotomy inflammation in patients referred to Hajar Hospital in Shahrekord
Design
Double-blind, randomized phase 3 clinical trial on 195 patients. A table of random numbers is used for randomization.
Settings and conduct
A double-blind study in which researchers and participants are unaware of the drug used on women referred to Hajar Hospital in Shahrekord. Patients are randomly divided into 3 groups: control group receiving routine care (lubricant gel) for 10 days The first group of routine care + aloe vera gel (2 cm from the gel inside the tube) episiotomized for 10 days The second group of routine care + 5% lavender essential oil gel for 10 days Finally, the extent of inflammation and infection of the episiotomy wound is examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria included age 18 to 35 years, BMI 19.8 to 26 kg / m2, gestational age 37-42 weeks, infant weight between 2500 to 4000 g, singleton pregnancy, primiparous, no specific disease (cardiovascular disease) , Liver, kidney, diabetes, immunodeficiency, depression), no smoking, alcohol and drugs, no long-term rupture of the membrain> 18 hours. Exclusion criteria include hematoma, infection, obstruction of labor (prolongation of labor and dystocia), need for resuscitation, extended episiotomy, heavy postpartum hemorrhage, vacuum use, postpartum perineal manipulation, allergy to aloe vera or lavender
Intervention groups
Control group receiving routine care (lubricant gel) for 10 days The first group of routine care + aloe vera gel (2 cm from the gel inside the tube) episiotomized for 10 days The second group of routine care + 5% lavender essential oil gel for 10 days
Main outcome variables
Inflammation and infection of the episiotomy wound

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210607051509N1
Registration date: 2021-11-21, 1400/08/30
Registration timing: prospective

Last update: 2021-11-21, 1400/08/30
Update count: 0
Registration date
2021-11-21, 1400/08/30
Registrant information
Name
zahra abedi koupaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3335 1044
Email address
st-abedikoupaee.z@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of topical effect of aloe vera gel and lavender essential oil in faster healing and reduction of episiotomy inflammation in patients referred to Hajar Hospital in Shahrekord
Public title
Comparison of Aloe-vera gel and lavender essential oil on inflammation of episiotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index 19.8 to 26 kg per square meter Gestational age 37-42 weeks Baby weight between 2500 and 4000 grams Single pregnancy Primi-para No specific disease (cardiovascular disease, liver, kidney, diabetes, immunodeficiency, depression) No smoking, alcohol and drugs No long-term rupture of the membrain for more than 18 hours
Exclusion criteria:
Hematoma, Infection, Disorders of labor (prolongation of labor and vestibule), Neonatal resuscitation, Episiotomy, Excessive postpartum hemorrhage, Vacuum use, Postpartum perineal manipulation, Aloe-vera or lavender allergy
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 195
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is divided using code 1 and code 2 cards and selected by the patient. And the rest enter in groups one by one.
Blinding (investigator's opinion)
Double blinded
Blinding description
The tube is packaged and coded by a pharmacist colleague. The patient and the researcher are unaware of its contents.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Parastar Aven.Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Approval date
2021-06-23, 1400/04/02
Ethics committee reference number
IR.SKUMS.REC.1400.081

Health conditions studied

1

Description of health condition studied
Episiotomy
ICD-10 code
O71
ICD-10 code description
Other obstetric trauma

Primary outcomes

1

Description
Infection rate
Timepoint
The third, seventh and tenth day
Method of measurement
REEDA scale

Secondary outcomes

1

Description
Inflammation rate
Timepoint
Day 3- 7 -10
Method of measurement
Iran Phlebitis Checklist

Intervention groups

1

Description
Control group: Patients receiving routine care (receiving lubricant gel) daily for up to 10 days
Category
Treatment - Drugs

2

Description
Intervention group 1: Routine care + aloe vera gel (2 cm from the gel inside the tube) episiotomized for 10 days
Category
Treatment - Drugs

3

Description
Intervention group 2: Routine care + 5% lavender essential oil gel daily for 10 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar Hospital, Shahrekord
Full name of responsible person
Lobat Jafarzade
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
shivaabedik@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghy
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
shivaabedik@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Abedi Koupaee
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
shivaabedik@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Abedi Koupaee
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
shivaabedik@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Abedi Koupaee
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
shivaabedik@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
2022-2023
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
I have not decided yet
From where data/document is obtainable
I have not decided yet
What processes are involved for a request to access data/document
I have not decided yet
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