Evaluation the effect of mastic Arnebia euchroma Ointment resin on wound healing and perineal pain after childbirth in women had episiotomy in alborz in 1397
To determine the effect of mastic Arnebia euchroma Ointment on pain intensity and healing of episiotomy in nulliparous women in Alborz in 2018.
Design
Design, The study population consists of nulliparous women referred to the maternity hospital and had episiotomy. This is a single-blind randomized clinical trial.
Settings and conduct
Setting and conduct, The sample size consists of 190 people. They will be randomly put into the two groups of control and intervention according to the inclusion criteria. Block randomization method will be used for random sampling.
Participants/Inclusion and exclusion criteria
Inclusion criteria: no systemic disease; no use of immunosuppressant drugs and corticosteroids; no acute disease and constipation
Exclusion criteria: history of mental and personality illness; difficult delivery; death of neonate, IUFD; Infection; grade three and four laceration; history of allergy to herbal medicines used in ointment
Intervention groups
Partcipants, Mothers’ entrance to the research will be done 4 hours after delivery with their consent. In control group, individuals will receive usual health recommendations according to the country’s protocol and the ones in the Arnebia euchroma Ointment group will be provided with Arnebia euchroma Ointment Data collection will be performed by completing the questionnaire from the 4 hours after delivery.
Main outcome variables
Pain, wound healing.
General information
Reason for update
Acronym
بهبود و شدت درد زخم اپی زیاتومی
IRCT registration information
IRCT registration number:IRCT20180110038302N2
Registration date:2018-04-29, 1397/02/09
Registration timing:registered_while_recruiting
Last update:2018-04-29, 1397/02/09
Update count:0
Registration date
2018-04-29, 1397/02/09
Registrant information
Name
Mansoureh Yazdkhasti
Name of organization / entity
Alborz University medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 4401 8856
Email address
m.yazdkhasti@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-20, 1396/12/29
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of mastic Arnebia euchroma Ointment resin on wound healing and perineal pain after childbirth in women had episiotomy in alborz in 1397
Public title
Evaluation the effect of mastic Arnebia euchroma Ointment resin on wound healing and perineal pain after childbirth in women had episiotomy in alborz in 1397
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
.Inclusion criteria؛ Healthy mothers (without anemia؛ HB>9g/dl ؛ lack of systemic disease؛ not taking immunosuppressive drugs and corticosteroids؛ lack of acute or chronic disease such as diabetes؛ high blood pressure and kidney failure؛ lack of constipation and hemorrhoids؛ sickle cell؛ and cancer treatment (chemotherapy؛ radiotherapy) ...)؛ avoiding the use of tobacco (cigarettes؛ hookahs؛ tobacco؛ naswar ...) and antibiotics during pregnancy؛ and gestational age؛ live fetus with head؛ spontaneous pain of labor without induction؛ no long-term rupture of water bag (more than 12 hours)؛
Exclusion criteria:
. Exclusion criteria؛ Evidence of infection (temperature higher than 38)؛ Meconium-stained amniotic fluid؛ rupture grade 3 and 4؛ a history of sensitivity to mastic gum؛ varicosity and hemorrhoids؛ The women suffering from hematoma will be excluded؛ Moreove the women with a history of mental and personality illnesses؛ preterm labor؛ difficult delivery؛ abnormal infant؛ hospitalized infants؛ neonatal death
Age
From 14 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
190
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Design, The study population consists of nulliparous women referred to the maternity hospital and had episiotomy in 2016 in karj
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Alborz University of Medical Science
Street address
Department of Nursing., Alborz University of Medical Science., Eshteraki St., Baghestan Blv
City
karj
Province
Alborz
Postal code
561-31452
Approval date
2018-03-09, 1396/12/18
Ethics committee reference number
1396.213َ
Health conditions studied
1
Description of health condition studied
epizytomy
ICD-10 code
O90
ICD-10 code description
Complications of the puerperium, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
4 hours after intervention Days3،5،10
Method of measurement
rule Pain
Secondary outcomes
1
Description
Wound healing
Timepoint
4 hours after intervention Days3،5،10
Method of measurement
REEDA observation form
Intervention groups
1
Description
Control group: In control group, individuals will receive usual health recommendations according to the country’s protocol.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali hospital
Full name of responsible person
Dr. Mansoureh Yazdkhshti
Street address
Karaj-Baghestan- Southern Common Blvd.-Alborz Nursing-Midwifery Faculty
City
Karj
Province
Alborz
Postal code
1829346253
Phone
+98 26 3430 4499
Email
Mansoyazd@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Mansoureh Yazdkhshti
Street address
Karaj-Baghestan- Southern Common Blvd.-Alborz Nursing-Midwifery Faculty
City
Karj
Province
Alborz
Postal code
1829346253
Phone
+98 26 3430 4499
Email
Mansoyazd@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Karaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Karaj University of Medical Sciences
Full name of responsible person
Dr. Mansoureh Yazdkhshti
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Karaj-Baghestan- Southern Common Blvd.-Alborz Nursing-Midwifery Faculty
City
karj
Province
Alborz
Postal code
1829346253
Phone
+98 26 3430 4499
Email
Mansoyazd@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Mansoureh Yazdkhshti
Position
استادیار
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Karaj-Baghestan- Southern Common Blvd.-Alborz Nursing-Midwifery Faculty
City
karj
Province
Alborz
Postal code
1829346253
Phone
+98 26 3430 4499
Email
Mansoyazd@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Shokufe Torkashvand
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Karaj-Baghestan- Southern Common Blvd.-Alborz Nursing-Midwifery Faculty
City
karj
Province
Alborz
Postal code
1829346253
Phone
+98 26 3430 4499
Email
shokufetorkashvand@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 program for its release
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