The aim of this study is to assess the effect of Green tea ointment on perineal pain and healing of episiotomy wound. In this double-blind, randomized, placebo-controlled trial, 99 postpartum women will be allocated into three groups. They will receive green tea or placebo ointment or betadin. They will be instructed to wash hands and the perineum thoroughly and dry it with a clean tissue every time before using the ointment, then put a length of one knuckle of ointment (approximately 2 cm) on the stitch area after 1-2 min using a sterile pad. This procedure will be repeated twice daily for 10 d. Perineal pain and wound healing will be assessed by using visual analogue scale and REEDA scale (0-15), before the intervention and 12 hours after delivery, 5 and 10 days postpartum. The investigators and participants will unaware of the type of ointment given to every participant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011225983N1
Registration date:2016-04-01, 1395/01/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-01, 1395/01/13
Registrant information
Name
Hadis Shahrahmani
Name of organization / entity
School of Nursing and Midwifery of Shahid Beheshti
Country
Iran (Islamic Republic of)
Phone
+98 21 23871
Email address
hadis.rahmani92@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Iran University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of the ointment of green tea on the intensity of episiotomy pain and wound healing in primiparous women
Public title
Assessing the effect of the ointment of green tea on the intensity of episiotomy pain and wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: primiparous woman; gestational ages between 37 to 42 weeks; aged 18 to 35 year; BMI between 19.8-30 kg/m2; resident in kerman; was educated; singleton birth with cephalic presentation; child weigh between 2500 to 4000 grams; have a vaginal delivery with mediolateral episiotomy without instrumental delivery and without tears; no rupture of membranes more than 24 hours; not eclampsia and pre-eclampsia; no manual removal of placenta; not taking the first stage of labor (more than 14 hours) and the second stage of labor (more than 2 hours) and the third stage of labor (more than 30 minutes); no fetal anomaly or bedfast to the neonatal unit; have hematoma episiotomy; no addiction; no allergies to topical drugs; the lack of diseases such as chronic systemic disorders, cardiovascular, respiratory, coagulation disorders and connective tissue, diabetes, anemia, immunosuppressant, hemophilia, malnutrition and psychological disorders; no history of injury, or previous surgery of lesions visible in the perineum (genital warts, hemorrhoids), persistent constipation
Exclusion criteria: do not visit for care; not interested to continue to participate in the study; do not use the ointment properly and as directed; do not use the betadin properly and as directed; allergic to use ointment; have a sex in the first 5 days after birth; manipulation of the perineum after episiotomy repair; Severe bleeding after childbirth; use drugs on wound healing (anticoagulant, antidepressants, antiepileptic, alcohol, immunosuppressant drugs, antibiotics, chemotherapy) during the study
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Velenjak St, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Postal code
1985717443
Approval date
2015-07-13, 1394/04/22
Ethics committee reference number
SBMU2.REC.1394.9
Health conditions studied
1
Description of health condition studied
episiotomy
ICD-10 code
O70.1
ICD-10 code description
Second degree perineal laceration during delivery
Primary outcomes
1
Description
Intensity of episiotomy pain
Timepoint
before intervention, 12 hours, 5 and 10 days postpartum.
Method of measurement
Visual Analogue Scale (VAS)
2
Description
wound healing of episiotomy
Timepoint
before intervention, 12 hours, 5 and 10 days postpartum.
Method of measurement
REEDA scale
Secondary outcomes
empty
Intervention groups
1
Description
Green tea ointment is used as much as one knuckle (2cm) on episiotomy wounds twice per day for 10 days.
Category
Treatment - Drugs
2
Description
placebo ointment is used as much as one knuckle (2cm) on episiotomy wounds twice per day for 10 days.
Category
Placebo
3
Description
betadin, 3 times a day for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Hadis Shahrahmani
Street address
Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Velenjak St, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery of Shahid Beheshti
Full name of responsible person
Hadis Shahrahmani
Position
Master of Science University Student of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Valiasr Ave, Niayesh Highway, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
hadis.shahrahmani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nourossadat Kariman
Position
Assistant Professor, PhD of Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Valiasr Ave, Niayesh Highway, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
n_kariman@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hadis Shahrahmani
Position
Master of Science University Student of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Valiasr Ave, Niayesh Highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 23871
Fax
+98 21 8820 2521
Email
hadis.shahrahmani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)