To determine the effect of Nigella sativa gel on pain and wound healing due to episiotomy
Design
Clinical trial with a control group, with parallel groups, triple blinded, randomized with blocking method, phase three on 60 patients. The randomizer software will be used for randomization.
Settings and conduct
This study will be performed in Dr. Mahzad Educational-Medical Center of Urmia. Nigella sativa gel will be used daily at the episiotomy site without massage for a week. Wound healing rate will be assessed by RIDA scale before discharge and 10±1 days after intervention. The mean pain intensity will be assessed before discharge and again on day 10±1 after the intervention by the Visual Pain Scale (VAS).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Live and single fetus delivery; Following a special diet; Willingness and possibility of the mother to visit the comprehensive women's center of Dr. Mahzad in Urmia on the 10th day.
Exclusion criteria: Using of specific medications (such as anti-inflammatory and anticoagulants); History of diseases that impair wound healing such as systemic, heart, kidney, lung, coagulation disorders, immunodeficiency, connective tissue disorders, diabetes, anemia, mental illness, hemophilia; Having severe anemia during pregnancy; Early bleeding after delivery; History of vaginal examinations and manipulations before delivery; Large or enlarged episiotomy; Long-term rupture of the amniotic sac (more than 18 hours); Addiction to drug and psychotropic substances.
Intervention groups
The intervention group 1 or treatment group: This group will receive Nigella sativa gel daily at the episiotomy site without massage for a week; The intervention group 2 or control group: This group will receive placebo gel daily at the episiotomy site without massage for a week.
Main outcome variables
Wound healing and pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N68
Registration date:2022-02-06, 1400/11/17
Registration timing:registered_while_recruiting
Last update:2022-02-06, 1400/11/17
Update count:0
Registration date
2022-02-06, 1400/11/17
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-29, 1400/11/09
Expected recruitment end date
2022-07-31, 1401/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Nigella sativa oil on pain and healing of episiotomy: a three-Blind randomized controlled trial
Public title
The effect of Nigella sativa oil on pain and healing of episiotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Delivery of a live and single fetus
Not following a special diet (according to the woman)
Willingness and possibility of the mother to visit the comprehensive women's center of Dr. Mahzad in Urmia on the 10th day
Exclusion criteria:
Long-term rupture of the amniotic sac (more than 18 hours)
Large or enlarged episiotomy
History of pre-delivery vaginal examinations and manipulations
Early vaginal bleeding after delivery
Having severe anemia during pregnancy
History of diseases that interfere with wound healing such as systemic, heart, kidney, lung, coagulation disorders, immunodeficiency, connective tissue disorders, diabetes, anemia, mental illness, hemophilia
Using of specific medications (such as anti-inflammatory drugs and anticoagulants based on the patient's statements)
Addiction to addictive and psychotropic substances (based on the woman's statements and case file)
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study will be assigned to two groups (one group receiving Nigella Sativa gel and one group receiving placebo gel with the same protocol) by block randomization method with block sizes of 4 and 6 and a allocation ratio of 1: 1. To hide the Allocation (Allocation Concealment), the allocation sequence will be identified by a person not involved in the study using a randomizer software, and the Nigella Sativa gel and placebo gel will be placed in the same packages numbered sequentially.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants, researcher and data analyst will be blinded in this study. Drug and placebo will be similar in appearance (shape, color, smell) and packaging of drug and placebo will be conducted by a person not involved in the research.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2021-11-28, 1400/09/07
Ethics committee reference number
IR.TBZMED.REC.1400.838
Health conditions studied
1
Description of health condition studied
Episiotomy wound healing
ICD-10 code
O90.1
ICD-10 code description
Disruption of perineal obstetric wound
Primary outcomes
1
Description
Wound healing score
Timepoint
Before discharge and 10±1 days after intervention
Method of measurement
REEDA scale
Secondary outcomes
1
Description
Pain score
Timepoint
Before discharge and 10 ± 1 days after intervention
Method of measurement
Visual Analog Scale
Intervention groups
1
Description
Intervention group or treatment group: Black seed gel with a concentration of 15% will be prepared by the pharmacy department of Tabriz University of Medical Sciences in the laboratory of the Pharmacy School and it will be used by the participants three times a day in the amount of one fingertip at the episiotomy site without massage for a week.
Category
Treatment - Drugs
2
Description
Control group: Placebo of black seed gel (paraffin) with a concentration of 15% will be prepared by the pharmacy department of Tabriz University of Medical Sciences in the laboratory of the Pharmacy School and it will be used by the participants three times a day in the amount of one fingertip at the episiotomy site without massage for a week.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Comprehensive Women's Hospital
Full name of responsible person
Afsaneh Alizadeh
Street address
Hassani Street
City
Urmia
Province
West Azarbaijan
Postal code
555751255
Phone
+98 44 3346 8815
Email
afsanehalizadeh@072gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947
Phone
+98 41 3479 6770
Email
afsanehalizadeh072@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Afsaneh Alizadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947
Phone
+98 41 3479 6770
Email
afsanehalizadeh072@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947
Phone
+98 41 3479 6770
Email
mirghafourvand@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afsaneh Alizadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947
Phone
+98 41 3479 6770
Email
afsanehalizadeh@072gmail.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
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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