Comparison of the effect of a combination cream of olive and honey versus routine care on episiotomy wound healing and its pain severity in primiparous women: a randomized clinical trial
To compare the effect of combination cream of olive and honey versus routine care on episiotomy wound healing and its pain severity in primiparous women
Design
This a randomized clinical trial, phase II, in which 80 eligible primiparous women will be randomly assigned to the intervention and control groups
Settings and conduct
The primiparous women with episiotomy who will refer to fatemieh Hospital during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of 18 to 40 years; term pregnancy; primiparous; normal delivery with episiotomy; normal body mass index.
Exclusion criteria: chronic disease; symptomatic vaginal infection; allergic diseases; rapture with grade of 3 or 4; puerperium fever.
Intervention groups
Intervention group: routine treatment plus topical use of a combination cream of olive and honey twice daily for 10 days.
Control group: just routine treatment.
Main outcome variables
Primary outcome: wound healing on 1, 7, 10, and 14 days after intervention through physical examination; severity of episiotomy pain on 1, 7, 10, and 14 days after intervention with using Mc Gill ruler.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N208
Registration date:2018-03-04, 1396/12/13
Registration timing:prospective
Last update:2018-03-04, 1396/12/13
Update count:0
Registration date
2018-03-04, 1396/12/13
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-11, 1396/12/20
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of a combination cream of olive and honey versus routine care on episiotomy wound healing and its pain severity in primiparous women: a randomized clinical trial
Public title
Comparison of the effect of a combination cream of olive and honey versus routine care on episiotomy wound healing and its pain severity in primiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 40 years
Term pregnancy
Primiparous
Normal delivery with episiotomy
Normal body mass index
Exclusion criteria:
Chronic disease
Symptomatic vaginal infection
Allergic diseases
Rapture with grade of 3 or 4
Puerperium fever
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-02-24, 1396/12/05
Ethics committee reference number
IR.UMSHA.REC.1396.823
Health conditions studied
1
Description of health condition studied
Episiotomy wound
ICD-10 code
O86.0
ICD-10 code description
Infection of obstetric surgical wound
Primary outcomes
1
Description
Wound healing
Timepoint
On 1, 7, 10, and 14 days after intervention
Method of measurement
Through physical examination
2
Description
Severity of episiotomy pain
Timepoint
On 1, 7, 10, and 14 days after intervention
Method of measurement
Using Mcgill ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus topical use of a combination cream of olive and honey twice daily for 10 days
Category
Treatment - Drugs
2
Description
Control group: Just routine treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Arezoo Shayan
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
arezoo.shayan2012@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Arezoo Shayan
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
arezoo.shayan2012@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arezoo Shayan
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
arezoo.shayan2012@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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
Undecided - It is not yet known if there will be a plan to make this available
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