Comparison effect of Calendula and Turmeric(Curcuma Longa) ointment on healing and pain severity of episiotomy in primiparous women attending selected hospital of shiraz university of medical sciences 2015-1016.
My objective is to test the comparison effect of Calendula and Turmeric(Curcuma Longa) ointment on healing and pain severity of episiotomy in primiparous women. 90 women who have episiotomy will be randomly divided into 2 intervention and 1 control group. one of the Intervention group will use Calendula ointment the other group will use Turmeric(Curcuma Longa) ointment on episiotomy incision every 8 hours.Control group will use Placebo on episiotomy incision. All groups in the ointment, receive routine care hospital.Our scale to check the wound healing is REEDA table. We check the healing process before and 3,7,10 , 14 days after intervention.Our scale to check the pain reliving is VAS ruler.We check the pain before and 3,7,10 , 14 days after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072023265N1
Registration date:2015-08-10, 1394/05/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-10, 1394/05/19
Registrant information
Name
Elahe Mahmoudi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 4352 6842
Email address
stud2420062868@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of Calendula and Turmeric(Curcuma Longa) ointment on healing and pain severity of episiotomy in primiparous women attending selected hospital of shiraz university of medical sciences 2015-1016.
Public title
Comparison effect of Calendula and Turmeric(Curcuma Longa) ointment on healing and pain severity of episiotomy.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: being primiparous; gestational age 37 to 42 weeks; vaginal delivery with episiotomy medio-lateral; havinng a singleton live child; cephalic presentation; pre-pregnancy body mass index less than 30; absence of reconstructive surgery on the vagina and perineum; do not use medications that effect wound healing; no specific disease( Anemia, cardiovascular disease, diabetes, immune dificiency, liver disease, depression, absence of coagulation disorders, preeclampsia, infectious diseases); lack of extending the incision and into the 3, 4 grade laceration or rupture exist except episiotomy. Exclusion criteria: manual removal of placenta; postpartum hemorrhage; hematoma formation; postpartum fever and chills(fever>38); manipulation of the perinum after delivery; episiotomy infections; need to re-stitch the episiotomy; the use of any ointment or cream other than what the researcher recives, Cause skin allergy by the use of ointment; unwillingness to continue to participate in the study.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2015-06-21, 1394/03/31
Ethics committee reference number
IR.SUMS.REC.1394.40
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
O90.1
ICD-10 code description
Disruption of perineal obstetric wound
Primary outcomes
1
Description
Severity of episiotomy pain
Timepoint
Before intervention then 3,7,10,14 days after intervention
Method of measurement
Visual Analouga Scale(VAS)
Secondary outcomes
1
Description
Healing of episiotomy
Timepoint
Before intervention then 3,7,10,14 days after intervention