The effect of olive cream on pain intensity and cesarean section in women
Design
semi-experimental design with the control group, the sample size will be108 patients.
Each group consists of 36 people.
Settings and conduct
This is a quasi-experimental design that will be performed on 108 women who have a cesarean section and who are referred to Arak Taleghani Hospital, Arak University of Medical Sciences, Arak, Iran. Sampling will be done by the available method. Random blocking will be done in the form of four blocks and women will randomly be divided into three groups: olive cream (n = 36), placebo group (n = 36)
And the control group (n = 36). The intervention group will use the olive cream twice a day from the second day of surgery until the tenth day after surgery, and the placebo group, which has a cream-like olive cream in terms of color and odor and appearance, like the olive cream and from day two to day 10, it will be used twice daily and the control group will receive routine care after surgery. Assessing the severity of pain and wound healing on days 2 and 10 will be done by the researcher using the Visual Analogue Scale (VAS). The duration of surgical wound healing from the onset of the study to 10 days after surgery will be calculated and will be compared in three groups.
Participants/Inclusion and exclusion criteria
Inclusion and exclusion criteria: Term pregnancy with BMI less than 30 and undergo cesarean section for the first or second time. If there is any disease or drug-related to wound healing, the sample will be excluded.
Intervention groups
Intervention group: use olive cream twice a day from the second day after cesarean to 10 days.
Placebo group: Use placebo 2 times a day from the second day after cesarean section to 10 days.
Control group: only routine post-operative care.
Main outcome variables
Pain Intensity ؛ Wound Healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180427039436N6
Registration date:2019-12-20, 1398/09/29
Registration timing:prospective
Last update:2019-12-20, 1398/09/29
Update count:0
Registration date
2019-12-20, 1398/09/29
Registrant information
Name
Leila Amiri Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1139
Email address
l.amirifarahani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Olive Cream on Pain Intensity and Cesarean Section Wound Healing among Women
Public title
The Effect of Olive Cream on Pain Intensity and Cesarean Section Wound Healing among Women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian
gestational age between 37 and 42 complete weeks
BMI less than 30
No history of cesarean section more than twice
Exclusion criteria:
chorioamnionitis
history of known diseases or drugs disrupting wound healing
Occurrence of any abnormalities that result in hospitalization of the neonatal intensive care unit (NICU)
excessive bleeding and theneed for blood transfusion
Hysterectomy or myomectomy Simultaneously with cesarean section
smoking or drug abuse
Prolonged rupture (more than 18 hours) of pre-operative amniotic fluid sac
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a quadratic block randomization method will be used.
Randomization tool is statistical software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Iran University of Medical Sciences
Street address
Hemat Highway next to Milad Tower, Tehran
City
tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-09-24, 1398/07/02
Ethics committee reference number
IR.IUMS.REC.1398.651
Health conditions studied
1
Description of health condition studied
cesarean section
ICD-10 code
o82
ICD-10 code description
Single delivery by caesarean section
Primary outcomes
1
Description
wound healing
Timepoint
2 days after cesarean section and 10 days after cesarean section
Method of measurement
REEDA Scale
2
Description
Pain Intensity
Timepoint
2 days after cesarean section and 10 days after cesarean section
Method of measurement
VAS scale (visual analogue scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: From the mothers of the intervention group who meet for the first time 2 hours after surgery, they will be asked to use 2 times oil creams at the site of the caesarean wound from day 2 after cesarean section until 10 days after surgery.
Category
Other
2
Description
Intervention group: The mothers in the placebo group will use a placebo twice a day after the second day of surgery, until the 10th day. A placebo that looks like a cream similar to the olive cream.
Category
Placebo
3
Description
Control group: The control group received neither local honey nor any of thelocal disinfectant materials (such as povidone iodine).The control group will receive routine postoperative care only.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
mahdiyeh taheri
Street address
Arak, the western side of Imam Khomeini Street next to the gas company, Taleghani Educational Center
City
arak
Province
Markazi
Postal code
3816149369
Phone
+98 86 3277 6065
Email
It-taleghani@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Iran University of Medical Sciences
Street address
Shahid Hemmat highway, District 2
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6650 9024
Fax
+98 21 6650 9024
Email
malakoutik@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mahdiye Taheri
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Rashid Yasemi st
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
taheri.mh1995@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahdiye Taheri
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Rashid Yasemi
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
taheri.mh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Rashid Yasemi
City
TEHRAN
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1139
Email
l.amirifarahani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available