Evaluating the effect of Frankincense ointment on pain intensity and improving Episiotomy injury
Design
A clinical trial with a control group, with a parallel, triple blind, randomized clinical trial
Settings and conduct
Research in Mehdiye Shoosh hospital will be performed on episiotomy ulcer.
This is a triple blind study, and the researcher, patient, and analyst will be blind
Participants/Inclusion and exclusion criteria
age18-35 years
Intervention groups
In the intervention group, the Frankincense ointment was used on episiotomy ulcers on days 1-5-10 postpartum. In the control group, ointment containing vaseline was also used in the same way.
Main outcome variables
reada score
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190110042320N1
Registration date:2019-03-09, 1397/12/18
Registration timing:registered_while_recruiting
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Elham laki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 0061
Email address
elham.laki@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Frankincense Ointment on pain intensity and improving Episiotomy injury in primiparous women
Public title
The effect of Frankincense Ointment on pain intensity and improving Episiotomy injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 - 35 years
Not having any hazardous background (Anemia, Infection, Diabetes and Etc
Be Primiparous
Gestational age 37 - 42 weak
Cephalic
Single baby and alive
Non-instrumental vaginal delivery with mediolateral episiotomy
Exit spontaneously of placenta
Maternal BMI between 19 / 8 - 26
Normal process of labor(In accordance with the plotogram chart)
Rupture of the bag under 18 hours
Exclusion criteria:
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are in accordance with a randomized pre-set table
, Were placed in one of the intervention or control groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
For the purpose of blindness, the drugs prepared with codes A and B that were prepared by a pharmacist of the project and The researcher and consultant of statistics and patients did not know the type of Ointment.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commite of Shahid beheshti university of medical sciences
Street address
Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-10-09, 1396/07/17
Ethics committee reference number
IR.SBMU.PHNM.13960848
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
O70.1
ICD-10 code description
Second degree perineal laceration during delivery
2
Description of health condition studied
Postpartum pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Healing Episiotomy location
Timepoint
on 1-5-10 day of postpartum
Method of measurement
Perineal Improvement Assessment Scale( REEDA )
2
Description
Intensity of pain
Timepoint
on 1-5-10 day of postpartum
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Episiotomy wound healing
Timepoint
On days 1, 5 and 10 after delivery
Method of measurement
Perineal Wound Healing Score (REEDA)
Intervention groups
1
Description
Therapeutic intervention group: Extract of Ointment Extract 2 times a day for 10 days (prepared and packed by the Faculty of Pharmacy of Shahid Beheshti University) at a rate of one finger (equivalent to one gram) will be applied locally to episiotomy.
Category
Treatment - Drugs
2
Description
Control group: placebo Ointment Extract 2 times a day for 10 days (prepared and packed by the Faculty of Pharmacy of Shahid Beheshti University) at a rate of one finger (equivalent to one gram) will be applied locally to episiotomy.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdiyeh Hospital
Full name of responsible person
Shahnaz Tork Zahrani
Street address
Valiasr ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2521
Email
zahranishahnaz@yahoo.com
2
Recruitment center
Name of recruitment center
Mahdiye hospital
Full name of responsible person
Shahnaz Tork Zahrani
Street address
Valiasre ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2521
Email
zahranishahnaz@yahoo.com
3
Recruitment center
Name of recruitment center
Mahdiye Hospital
Full name of responsible person
Shahnaz tork zahrani
Street address
valiasr ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2521
Email
zahranishahnaz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Tork Zahrani
Street address
Velynjak Ave., Chamran Highway, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2521
Email
zahranishahnaz@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham laki
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Valiasr ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2521
Email
Elham.laki70@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahnaz tork zahrani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
valiasr ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
zahranishahnaz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Laki
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Valiasr St. Al-Zahra dormitory
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2521
Email
Elham.laki@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available