Evaluation the effect of Punica granatum var. pleniflora ( Persian Gulnar) ointment on pain severity and healing of episiotomy wound in primiparous women
Determination the effect of Punica Granatum var. pleniflora (Persian Gulnar) ointment on pain severity and healing of episiotomy wound in primiparous women referred to Niknafs maternity hospital of Rafsanjan in 2022
Design
Randomized Clinical Trial with one intervention groups and one control group; Three blindsides; Parallel groups; Permuted block randomization
Settings and conduct
The statistical population of the research; Includes all nulliparous pregnant women referring tomaternity hospital in Rafsanjan. The sample size will be estimated based on the statistical formula (45 people in each group). This research will be a triple-blind study. In order to blinding, the pharmacist will be asked to define the medicines and placebo with group A_B and will put the prescription of them inside each package. Blinding will be done for the researcher, samples, clinical caregiver, and analyzer.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Inform consent for participant in the study; Willingness to normal vaginal delivery,Selection of Niknafs Maternity Center of Rafsanjan as the place of delivery; Mother age between 18-35 years; Pregnancy age: 38 weeks; Single-fetal with a cephalic presentation based on the latest ultrasound results; primiparous women; Iranian nationality; vaginal delivery with median or medio laterl incision; BMI 18/5-30
Exclusion criteria: Sensitivity to Punica granatum var. pleniflora; known history of psychological illness; History of psychological problems during 6 month ago
Consumption of Antidepressant medication; Drug consumption
Intervention groups
The intervention group apply Persian Gulnar ointment and the control group apply usrine ointment from 2 hours after delivery every 12 hours as a fingertip on the episitomy
Main outcome variables
The mean intensity of pain, healing episiotomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190717044248N7
Registration date:2023-03-20, 1401/12/29
Registration timing:registered_while_recruiting
Last update:2023-03-20, 1401/12/29
Update count:0
Registration date
2023-03-20, 1401/12/29
Registrant information
Name
Zahra Saghafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
z.saghafi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Punica granatum var. pleniflora ( Persian Gulnar) ointment on pain severity and healing of episiotomy wound in primiparous women
Public title
Evaluation the effect of Punica granatum var. pleniflora ( Persian Gulnar) ointment on pain severity and healing of episiotomy wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inform consent for participant in the study
Willingness to normal vaginal delivery
Selection of Niknafs Maternity Center of Rafsanjan as the place of delivery
Mother age between 18-35 years
Pregnancy age: 38 weeks based on reliable first-trimester ultrasound or last menstrual period
Single-fetal with a cephalic presentation based on the latest ultrasound results
primiparous women
Iranian nationality
vaginal delivery with median or medio laterl incision
BMI 18/5-30
Exclusion criteria:
Sensitivity to Punica granatum var. pleniflora
known history of psychological illness
History of psychological problems during 6 month ago
Consumption of Antidepressant medication
Drug consumption
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals who will have the inclusion criteria will be selected with the Convenience Sampling method.
The Permuted block randomization will be used to allocate people to two groups.
In this study, nine blocks (every block has 10 paces) will be created, so that after determining Individuals who will have the inclusion criteria, the first 10 people who enter the study will be divided intotwo groups randomly (assigning 5 people to each group), then the next 10 people will be divided into two groups randomly in the same way, and this method will be continued until the last block.
The output of the software will be English letters (A& B ) and each letter will be the representative of one of the intervention or control groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
At first, participants will be justified about the study, and will be informed consent will be taken.
For blinding, the pharmacist will be asked to identify the medicine and placebo
with the A_B group and the prescription in each package will be placed. So that the researcher would not know about the content of packages (medicine or placebo). The medicine is also will be given to participants as A or B , and participants will not be informed of the content of packages (medicine or placebo).
This blinding will also be available for the analyzer, and after finishing the statistical analysis the content of packages (medicine or placebo) will be asked from pharmacists.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Emam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
77179335777
Approval date
2022-01-10, 1400/10/20
Ethics committee reference number
IR.RUMS.REC.1400.227
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intensity of pain
Timepoint
Determination of intensity of pain score before applying the ointment, fifth and tenth after delivery
Method of measurement
Visual Analogue Scales of intensity pain
Secondary outcomes
1
Description
healing of episiotomy
Timepoint
Determination of healing of episiotomy before applying the ointment, fifth and tenth after delivery
Method of measurement
REEDA
Intervention groups
1
Description
Intervention group apply as much as a fingertip 5% of Persian Gulnar ointment made by SHahid Beheshti School of Pharmacy in Tehran 2 hours after delivery on the episiotomy site
Category
Treatment - Drugs
2
Description
Control group apply as much as a fingertip of userin ointment made by SHahid Beheshti School of Pharmacy in Tehran 2 hours after delivery on the episiotomy site
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nik Nafs Maternity center of Rafsanjan
Full name of responsible person
Zohre Sahebi
Street address
No.38, 40th Alley, Meraj Shomali Aven
City
Rafsanjan
Province
Kerman
Postal code
7719678375
Phone
+98 913 191 0362
Email
sahebizm@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinezhad
Street address
Deputy of research and technology, Building Num 3, Central Organization of University of Medical Sciences, Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7718146890
Phone
+98 34 2834 7200
Email
vcrt@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Maryam Azarian far
Position
Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
NO.1, Keshavarz 2 Alley, Sharaf Abad Ave
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591637816
Phone
+98 74 3344 4656
Email
azarian.maryam.98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Zahra Saghafi
Position
Totur
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
nursing and midwifery scool, sahely Blvd, Motahary street
City
Rafsanjan
Province
Kerman
Postal code
7718145056
Phone
+98 34 2834 7100
Email
z.saghafi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Hossein GHaedamini
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Midwifery
Street address
No.30,15th Yadegar Alley, Yadegar Emam Ave, Yadegar Emam Town
City
Rafsanjan
Province
Kerman
Postal code
7714186759
Phone
+98 34 3434 0454
Email
ghaedaminih@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
Confidentiality of information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available