evaluate the effect of sesame ointment on pain intensity of episiotomy and wound healing
Design
the study population consisted of women admitted to Akbar Abadi maternity hospital admitted for normal birth.The research sample consisted of 104 primiparous women who were randomly assigned to quadruple blocks.
Settings and conduct
Evaluation of healing of episiotomy and pain intensity before,7 and 10 days after intervention was done by a trained researcher and recorded in the form of healing wound of REEDA and pain form VAS.Ointments are packed in the same color and aroma with the same codes as A,B and will be placed on samples according to the letters inserted in the form of the drug form.
Participants/Inclusion and exclusion criteria
Age18-35؛gestational age42-37weeks؛lack of addiction and psychotropic drug؛single cephalic fetus؛no history of damage or previous surgery and visible lesions in the perineum؛lack of rectocele and severe cystosclerosis grade 2؛anesthesia with lidocaine1%؛episiotomy incision45°and medial؛lack of vaginal symptom inflammation؛having BMI lower than 30؛no coagulation؛connective tissue disorders؛diabetes؛Anemia؛immune deficiency؛malnutrition؛no amniotic rupture for more than 24 hours؛lack of long or fast delivery؛having separate sutures restored with CutCuteCotton.fever؛hemmatoma؛abnormal vaginal bleeding؛Postpartum curettage
Intervention groups
intervention group(sesame ointment)and control group(placebo) use ointments every 8 hours for10days.
Main outcome variables
pain intensity is different before and 7 days after treatment with sesame ointment and placebo;pain intensity7 and 10 days after treatment with sesame ointment and placebo;the wound healing before and 7 days after treatment s different from treatment with sesame ointment in placebo;The wound healing of episiotomy 7 and10 days is different from treatment with sesame ointment in placebo.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170112031902N2
Registration date:2018-04-09, 1397/01/20
Registration timing:retrospective
Last update:2018-04-09, 1397/01/20
Update count:0
Registration date
2018-04-09, 1397/01/20
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 91208360111
Email address
najmeseven@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the ointment of Sesamum on the intensity of episiotomy pain and wound healing
Public title
The effect of the ointment of Sesamum on the episiotomy wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 35 years old
gestational age of 42-37 weeks
lack of susceptibility to certain drugs in the past
living with a spouse
llack of addiction and psychotropic drugs
lack of history of hepatocellular disorders
single fetus with cephalic presentation
no history of damage Or previous surgery and visible lesions in the perineum
lack of rectocele and severe cystosclerosis grade 2 and upper wall or mass in the vaginaperineal anesthesia with lidocaine 1%
perineal anesthesia with lidocaine 1%
episiotomy incision 45 ° and medial lateral
lack of vaginal symptom inflammation At the onset of the study
having no BMI greater than 30
no coagulation and connective tissue disorders, diabetes Anemia, immune deficiency, malnutrition
no amniotic rupture for more than 24 hours
lack of long or fast delivery
having separate sutures that have been restored with Cut Cute Cotton.
Exclusion criteria:
presence of a fever
Hematoma formation
Perform curettage action
Abnormal vaginal bleeding
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
By random allocation method, blocked in one of the intervention and control groups by random block method with two patients.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to blind the study, the research and statistical analysis group and mothers will not be aware of the type of ointment used.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethicts committee of Iran University of Medical Sciences
Street address
Tehran, Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-12-03, 1396/09/12
Ethics committee reference number
IR.IUMS.REC 1396.9311373003
Health conditions studied
1
Description of health condition studied
episiotomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of pain in episiotomy
Timepoint
Before, 7 and 10 days after intervention
Method of measurement
Visual Analog Scale (VAS)
2
Description
Healing episiotomy
Timepoint
Before, 7 and 10 days after intervention
Method of measurement
REEDA tool
Secondary outcomes
empty
Intervention groups
1
Description
In this study, the sesame oil ointment brand Burnagol, a pharmaceutical company of Gol-Dara, was approved by the Food and Drug Administration of Iran, with beta-cytosterol at 0.25% as the main ingredient in the trace element of sesame oil. Four hours after episiotomy repair, use a cuff (equivalent to 25 mg) of ointmenton episiotomy location every 8 hours for ten days.
Category
Treatment - Drugs
2
Description
Control group: In this study, the placebo ointment in Shahid Beheshti Pharmaceutical Faculty was created at the faculty laboratory with the same amount, shape, odor, color and tube similar to the intervention drug, the main basis of which is vaseline (other materials are neutral compounds). It should be noted that the base of each ointment is one, so there is no need for another control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abadi Hospital
Full name of responsible person
Najme Amani Babadi
Street address
Tehran, Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
najmeseven@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Masoome Kheirkhah
Street address
Valis Asr Street, Above Vanak Square, Rashidiassemi Avenue, Iran Nursing and Midwifery Faculty
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
najmeseven@gmail.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
Najme Amani Babadi
Position
Student of Master of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Valis Asr Street, Above Vanak Square, Rashidiassemi Avenue, Iran Nursing and Midwifery Faculty