The Compare of effect of Camellia sinensis (green tea) and the Myrtus communis ointment on the perineal pain and episiotomy wound healing in nulliparous women.
The Compare of effect of Camellia sinensis (green tea) and the Myrtus communis ointment on the perineal pain and episiotomy wound healing in nulliparous women.
Design
Participants randomly pick one card.The researcher does not know which card contains which ointment. Outcome Assessor (midwife) records the outcome of each individual trial without knowing the person participating in the study.
Settings and conduct
Prior to the intervention, the exper midwife will train face to face all three groups about how to care of the perineum and sutures, personal hygiene, nutrition, physical activity, and how to use ointment. Research samples are asked to put one finger strap on the suture area after washing and drying the perineal area, to cover it, and then use a sanitary pad after 10 minutes. Continue twice a day, morning and night before bedtime for 14 days after delivery. The first dose of the drug will be administered in the first 24 hours (at least 2 hours after episiotomy repair) by the patient with the supervision of a researcher at the hospital.If you do not relieve the pain of painkillers Research units will be free to use painkillers after completing the VAS questionnaire ( use 250 mg Mefenamic Acid Pain Score Score). episiotomy improvement will be evaluated on days 7, 10, and 14 .so researcher will Call the patient to observe episiotomy improvement in Elahadi and Ganjavian hospital at 6, 9, and 13 days postpartum based on Objective Wound Assessment (REEDA) and VAS Pain Assessment Tool (by the researcher) Check and record.
shoushtar alhadi Hospital - Ganjavian Dezful Hospital
Participants/Inclusion and exclusion criteria
nulliparous women
Singleton live fetus
BMI in the range of 19.8-29.9
Baby weight between 2500-4000 gr
Intervention groups
Green Tea Ointment
Myrtus communis ointment
Main outcome variables
perineal pain and episiotomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190804044428N1
Registration date:2019-10-04, 1398/07/12
Registration timing:registered_while_recruiting
Last update:2019-10-04, 1398/07/12
Update count:0
Registration date
2019-10-04, 1398/07/12
Registrant information
Name
Azam Jahngirimehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3622 8926
Email address
jahangirimehr-a@shoushtarums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Compare of effect of Camellia sinensis (green tea) and the Myrtus communis ointment on the perineal pain and episiotomy wound healing in nulliparous women.
Public title
The Compare of effect of Camellia sinensis (green tea) and the Myrtus communis ointment on the perineal pain and episiotomy wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
nulliparous women
Singleton live fetus
BMI in the range of 19.8-29.9
Baby weight between 2500-4000 gr
Exclusion criteria:
using the drugs that prevent the maternal wound healing
diseases affecting wound healing
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are sorted by random allocation. Cards will be prepared in three colors (for the three study groups) and placed in a bag and the samples will be asked to randomly pick one of the cards.The color of the card will determine the type of ointment tube. The color of the card and the tube will be recorded in the research sample questionnaire.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants randomly pick a card and a researcher unaware of what color of lipstick which each person has his own record cards. Outcome Assessor (midwife) records the outcome of each individual trial without knowing the person participating in the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shoushtar faculty of Medical sciences
Street address
Shahid Rajaee West intersection, Shoushtar faculty of Medical sciences
City
SHoushtar
Province
Khouzestan
Postal code
6451684534
Approval date
2019-07-10, 1398/04/19
Ethics committee reference number
IR.SHOUSHTAR.REC.1398.004
Health conditions studied
1
Description of health condition studied
perineal pain and episiotomy
ICD-10 code
085-092
ICD-10 code description
Chapter XV:Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Pain level
Timepoint
7, 10 and 14 postpartum
Method of measurement
VAS index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Green Tea Ointment
Category
Treatment - Other
2
Description
Intervention group: Myrtus communis ointment
Category
Treatment - Other
3
Description
Control group: Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
AL-Hadi Hospital
Full name of responsible person
Masoumeh Saiahi
Street address
Shahid Rajai intersection
City
shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3621 0399
Email
research@shoushtarums.ac.ir
2
Recruitment center
Name of recruitment center
Ganjavian Hospital
Full name of responsible person
Masoumeh Saiahi
Street address
At the beginning of Andimeshk Road - in front of the 292th Armored Brigade
City
dezfool
Province
Khouzestan
Postal code
6461665145
Phone
+98 61 4242 2040
Email
bbd@dums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Medical Sciences of shoushtar
Full name of responsible person
Sayahi Masoumeh
Street address
Faculty of Medical Sciences of shoushtar, Alhadi Hospital, Shahid Rajaei intersection
City
shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 8927
Email
research@shoushtarums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Medical Sciences of shoushtar
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
Faculty of Medical Sciences of shoushtar,
Full name of responsible person
Saiahi Masoumeh
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Medical Sciences of shoushtar, , Alhadi Hospital, Shahid Rajaei intersection
City
shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 8927
Email
m.saiahi430@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Medical Sciences of shoushtar
Full name of responsible person
Saiahi Masoumeh
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Medical Sciences of Shoushtar, AL-Hadi Hospital,Shahid Rajaei intersection
City
shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 8927
Email
m.saiahi430@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Medical Sciences of Shoushtar
Full name of responsible person
Saiahi Masoomeh
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Medical Sciences of Shoushtar , Al-Hadi Hospital,Shahid Rajaei intersection,
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 8927
Email
m.saiahi430@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
Because of the confidentiality of each person's study results
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