The effectiveness of olive and black seed oil combination in pain intensity and episiotomy wound healing in prim parous women referred to hospitals under the auspices of Babol University of Medical Sciences
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General information
2023-09-22, 1402/06/31
2025-03-19, 1403/12/29
20232025-0903-2219 00:00:00
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The impossibility of sampling in the initial forecast period due to the non-cooperation of some gynecologists
The impossibility of sampling in the initial forecast period due to the non-cooperation of some gynecologists
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عدم امکان نمونه گیری در مدت پیش بینی شده اولیه به دلیل عدم همکاری برخی متخصصین زنان
عدم امکان نمونه گیری در مدت پیش بینی شده اولیه به دلیل عدم همکاری برخی متخصصین زنان
Recruitment centers
#1
Name of recruitment center - English: Babol University of Medical Sciences
Name of recruitment center - Persian: دانشگاه علوم پزشکی بابل
Full name of responsible person - English: fereshteh behmanesh
Full name of responsible person - Persian: فرشته بهمنش
Street address - English: Babol, Keshavarz St. - Babol University of Medical Sciences
Street address - Persian: بابل، خیابان کشاورز- دانشگاه علوم پزشکی بابل
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4717647745
Phone: +98 11 3219 9594
Fax:
Email: f.behmanesh@mubabol.ac.ir
Web page address: https://yahya.mubabol.ac.ir
Name of recruitment center - English: Babol University of Medical Sciences
Name of recruitment center - Persian: دانشگاه علوم پزشکی بابل
Full name of responsible person - English: Fereshteh Behmanesh
Full name of responsible person - Persian: فرشته بهمنش
Street address - English: Babol University of Medical Sciences, Keshavarz St, Babol, Mazandaran
Street address - Persian: مازندران، بابل، خیابان کشاورز- دانشگاه علوم پزشکی بابل
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4717647745
Phone: +98 11 3219 9594
Fax:
Email: f.behmanesh@mubabol.ac.ir
Web page address: https://yahya.mubabol.ac.ir
Name of recruitment center - English: Babol University of Medical Sciences Name of recruitment center - Persian: دانشگاه علوم پزشکی بابل Full name of responsible person - English: fereshteh behmaneshFereshteh Behmanesh Full name of responsible person - Persian: فرشته بهمنش Street address - English: Babol, Keshavarz St. - Babol University of Medical Sciences, Keshavarz St, Babol, Mazandaran Street address - Persian: مازندران، بابل، خیابان کشاورز- دانشگاه علوم پزشکی بابل City - English: Babol City - Persian: بابل Province: Mazandaran Country: Iran (Islamic Republic of) Postal code: 4717647745 Phone: +98 11 3219 9594 Fax: Email: f.behmanesh@mubabol.ac.ir Web page address: https://yahya.mubabol.ac.ir
Protocol summary
Study aim
Determining the effectiveness of olive and black seed oil combination in pain intensity and episiotomy wound healing in prim parous women referred to hospitals under the auspices of Babol University of Medical Sciences
Design
A clinical trial with 2 intervention and 1 control groups. 3 blind strains, 108 randomized samples with blocks of four and open label in three groups
Settings and conduct
The researcher will select and randomly assign the samples to two intervention groups and one routine care group according to the study entry criteria.
Eligible people are placed in one of three groups A: 36 people, B: 36 people, and C: 36 people, using permuted block randomization and open label. The size of the blocks is 6 and in each block each intervention group will be repeated twice. 18 blocks of 6 will be produced to create a sequence of size 108.
In order to hide the list of random allocation, a special code will be assigned to each of the intervention groups, which only the main implementer of the project will be aware of.
Location: Hospitals covered by Aluk Medical University of Babol.
People in the intervention group use a glass containing oils with a dose of 10 drops locally and 3 times a day 24 hours after delivery, for 10 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: primiparous women, normal delivery with episiotomy, having literacy, BMI <30.
Exclusion criteria: lack of personal desire to continue the study, lack of regular use of oils, 4th degree tear,history of skin dermatitis, history of allergies and eczema to plants, history of gestational diabetes and obvious
Intervention groups
Two intervention groups receiving the combination of olive oil and black seed. Olive oil alone. Control group receiving routine care
The impossibility of sampling in the initial forecast period due to the non-cooperation of some gynecologists
Acronym
IRCT registration information
IRCT registration number:IRCT20180218038783N2
Registration date:2022-12-23, 1401/10/02
Registration timing:prospective
Last update:2023-12-29, 1402/10/08
Update count:1
Registration date
2022-12-23, 1401/10/02
Registrant information
Name
Fereshteh Behmanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0504
Email address
f.behmanesh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-05, 1401/11/16
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of olive and black seed oil combination in pain intensity and episiotomy wound healing in prim parous women referred to hospitals under the auspices of Babol University of Medical Sciences
Public title
The effectiveness of olive and black seed oil combination in pain intensity and episiotomy wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women
Normal delivery with episiotomy
Having literacy
BMI < 30
Exclusion criteria:
The personal unwillingness of the participants to continue the study,
Women who do not use oils regularly.
4th degree tear
History of diagnosed skin dermatitis
History of allergy and eczema diagnosed to plants
History of gestational diabetes and obvious
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher will select the samples according to the Inclusion criteria and assign them randomly (using the block randomized method) to two groups of intervention and routine care.
Eligible people are placed in one of three groups A: 36 people, B: 36 people, and C: 36 people, using permuted block randomization and open label. The size of the blocks is 6 and in each block each intervention group will be repeated twice. 18 blocks of 6 will be produced to create a sequence of size 108.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to hide the list of random allocation, a special code will be assigned to each of the intervention groups, which only the main executor of the project (supervisor) will be aware of. Also, the second moderator, who is a student and evaluator of the study and the person who performs the statistical analysis, will not know about the codes assigned to the drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Mazandaran, Babol, Ganj Afrooz Street, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4774547176
Approval date
2022-12-12, 1401/09/21
Ethics committee reference number
IR.MUBABOL.REC.1401.145
Health conditions studied
1
Description of health condition studied
Episiotomy pain intensity
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
2
Description of health condition studied
Episiotomy wound repair
ICD-10 code
O86.0
ICD-10 code description
Infection of obstetric surgical wound
Primary outcomes
1
Description
The intensity of pain in the episiotomy area is based on the person's statements, where 0 means the least pain and 10 means the most possible pain.
Timepoint
24 hours after delivery (before the start of the intervention) and on the 10th day after starting the topical use of oils
Method of measurement
10 cm pain ruler scale
2
Description
Healing of episiotomy wound based on measuring the variables of swelling, bruising, redness and the distance between the two edges of episiotomy wound in lithotomy position.
Timepoint
24 hours after delivery (before the start of the intervention) and on the 10th day after starting the topical use of oils
Method of measurement
ٍEpisiotomy wound healing REEDA scale
Secondary outcomes
1
Description
Burning and itching
Timepoint
The first ten days after delivery
Method of measurement
Examination
2
Description
Episiotomy opening
Timepoint
The first ten days after delivery
Method of measurement
Examination
3
Description
The need for painkillers
Timepoint
The first ten days after delivery
Method of measurement
Examination
Intervention groups
1
Description
Intervention group 1: recipient of black seed oil and olive:All the subjects of the study will be taught how to follow the health tips after childbirth, and the samples of the intervention group will be taught how to use the container containing the oils. In such a way that they use the container containing black seed and olive oil with a dose of 10 drops locally and three times a day 24 hours after giving birth, for 10 days. The researcher also examines the severity of perineal pain and healing of episiotomy wound in the first 24 hours after delivery and ten days after that.
Category
Treatment - Other
2
Description
intervention group 2: Recipient of olive oil alone:All the subjects of the study will be taught how to follow the health tips after childbirth, and the samples of the intervention group will be taught how to use the container containing the oils. In such a way that they use a container containing olive oil with a dose of 10 drops locally and three times a day 24 hours after giving birth, for 10 days. The researcher also examines the severity of perineal pain and healing of episiotomy wound in the first 24 hours after delivery and ten days after that.
Category
Treatment - Other
3
Description
Control group: They receive routine cares.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol University of Medical Sciences
Full name of responsible person
Fereshteh Behmanesh
Street address
Babol University of Medical Sciences, Keshavarz St, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9594
Email
f.behmanesh@mubabol.ac.ir
Web page address
https://yahya.mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mehdi Rajab Nia
Street address
Ganj Afrooz Sreet, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4774547176
Phone
+98 11 3219 9592
Email
info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, Keshavarz street, Kargar Ave
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0504
Fax
Email
f.behmanesh2015@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Babol University of Medical Sciences, Keshavarz street, Kargar Ave
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0504
Fax
Email
f.behmanesh2015@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fereshteh behmanesh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Keshavarz street, Babol University Of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4774547176
Phone
+98 11 3219 9594
Email
f.behmanesh2015@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
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